Off Script: A Pharma Manufacturing Podcast: Recent Episodes
Pharma Manufacturing
The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing's print and online coverage, which follows the industry's biggest issues surrounding scale-up, technology innovations, regulations and more
The demands on pharmaceutical manufacturing quality teams are growing as they manage larger volumes of data driven by increasingly complex therapies and evolving regulatory expectations. In response, artificial intelligence is emerging as a powerful tool to help quality professionals synthesize information more efficiently, improve consistency across investigations, and support more informed decision-making.
In this episode of Off Script, we spoke with Charlie Lickfold, Chief Technology Officer at Catalent, about how the company is deploying AI to modernize pharmaceutical quality management. Lickfold explains why advanced modalities like cell and gene therapies are driving demand for AI-enabled quality systems, how Catalent’s new QAI platform is assisting in quality management, and why human oversight remains essential in regulated quality operations. He also discusses evolving regulatory expectations, AI governance, and organizational strategies that can support successful enterprise AI deployment.
Single-use technologies have reshaped biopharma manufacturing facility design, capacity strategy, and flexibility over the past decade. The industry has expanded with a growing range of targeted therapies and emerging modalities, which has led to manufacturers adopting single-use systems to meet demand. The shift has enabled more flexible facilities, faster product changeovers, and manufacturing strategies better suited to scaling next-generation biologics.
In this episode of Off Script, we spoke with Charlie Heise, associate director of Bioprocess Strategy and Development at Fujifilm Biotechnologies, about how single-use technologies have transformed facility design over the past decade and where things are headed. Heise discusses the industry's shift from process-specific plants to flexible manufacturing platforms, the growing role of single-use systems in continuous manufacturing and process intensification, and why standardization and digital integration are essential. He also explores how hybrid manufacturing models, regional production, and evolving therapeutic modalities will shape the next generation of biopharma manufacturing.
Biopharmaceutical manufacturing processes are becoming more complex, prompting manufacturers to evaluate filtration based on its impact across the entire process rather than as a standalone unit operation. Filtration decisions can influence everything from system footprint and flow performance to integration complexity, product recovery, and overall operational efficiency. Growing emphasis on sustainability and yield is also leading manufacturers to examine hidden inefficiencies.
In this episode of Off Script, sponsored by Saint-Gobain Critical Process Solutions, we spoke with Hannah Hertrick, market development manager of Filtration Products at Saint-Gobain, about how filtration is evolving into a system-level optimization opportunity. The conversation explores why filtration decisions increasingly extend beyond membrane performance, how filter design and connectivity can simplify system integration, and why manufacturers are taking a more holistic approach to improving process efficiency. Hertrick also discusses the challenge of holdup volume in high-value biologics, the impact of hidden product losses on yield and cost of goods, and the overall importance of reducing system complexity and improving product recovery.
A unique team of specialists in data generation and artificial intelligence are co-developing an AI genomic model capable of predicting genomic edits that improve commercial-scale protein production. This collaboration between Triplebar and UC Berkeley—with funding from the U.S. Department of Defense and the National Science Foundation through a BioMADE grant—aims to accelerate strain optimization for more resilient, cost-effective protein manufacturing across therapeutic and industrial applications.
In this episode of Off Script, we spoke with Shawn Manchester, CEO of Triplebar, about how the company's ultra-high-throughput microfluidics platform is being paired with UC Berkeley's genomic language model to transform strain engineering. Manchester discussed the motivation behind the collaboration, explained how this genomic language model differs from traditional AI approaches, and explored how they could improve protein expression, shorten development timelines, and reduce manufacturing costs. He also shared his vision for how AI-driven strain optimization could help enable the next generation of protein therapeutics and other biomanufactured products.
The FDA recently announced the participants in its PreCheck pilot program, an initiative designed to encourage earlier collaboration between regulators and companies developing new domestic pharmaceutical manufacturing facilities. By shifting facility readiness discussions earlier in the development process, the program aims to improve regulatory predictability, reduce manufacturing risk, and accelerate commercial launches, an approach that could be particularly valuable for advanced manufacturing technologies and complex therapeutic modalities like cell therapy.
In this episode of Off Script, we spoke with Fabian Gerlinghaus, co-founder and CEO of Cellares, about the company's selection as one of seven participants in the inaugural PreCheck cohort and what the program could mean for both Cellares and the future of cell therapy manufacturing. The conversation explores how earlier regulatory engagement will help de-risk commercial launches, why automation is changing the scalability of autologous cell therapies, and how standardized manufacturing platforms may enable faster global tech transfer. Gerlinghaus also discusses Cellares' strategy for building a global network of automated manufacturing facilities, the company's recent fundraising efforts to support its expansion, and the milestones—including a planned IPO—that will shape its next phase of growth.
As pharmaceutical manufacturers work to reduce energy consumption and meet sustainability targets, attention is expanding beyond core production processes to the utility systems that support manufacturing. Steam systems, which play a critical role in sterilization, heating, and HVAC operations, can account for a significant share of a facility's energy consumption. Yet things like manual inspection practices and undetected steam trap failures often leave manufacturers with unnecessary energy losses, higher emissions, and increased operating costs.
In this episode of Off Script, sponsored by Emerson, we spoke with Tom Belling, global director of Life Sciences at Emerson, about the growing role utilities play in pharmaceutical sustainability strategies, and the significance of steam systems within that. The conversation explores why steam systems have become an important opportunity for improving operational efficiency and how continuous monitoring technologies are helping manufacturers identify failures earlier without disrupting operations. Belling also discusses how wireless sensing, acoustic monitoring, and data-driven maintenance can improve reliability, support sustainability, and reduce maintenance costs while protecting product quality.
The advancement of pharmaceutical manufacturing depends heavily on the research taking place in areas such as continuous manufacturing, automation, machine learning, and AI. The maturation of these technologies will foster improved process optimization, accelerate the development of medicines, and make manufacturing more efficient and reliable.
This is the second part of our conversation with Thomas Roper, PhD, co-director of pharmaceutical engineering at Virginia Commonwealth University’s Center for Pharmaceutical Engineering and Sciences and graduate program director for chemical and life science engineering. Roper discusses how graduate students in his research group have helped advance technologies ranging from computational fluid dynamics and process analytical technology to machine learning applications for process optimization. He also shares why he views AI as a powerful tool, not a replacement for people, and how it’s preparing the next generation of scientists and engineers.
The framework of modern pharmaceutical manufacturing is evolving as new technologies, advanced therapeutic modalities, and more sophisticated process control reshape how medicines are developed. While biologics, peptides, and other emerging therapies continue to expand the industry's capabilities, advances in engineering, automation, and continuous manufacturing are also transforming small molecule manufacturing. These shifts are redefining the skills, technologies, and manufacturing strategies needed to deliver high-quality medicines more efficiently and reliably.
In this episode of Off Script, we spoke with Thomas Roper, PhD, co-director of pharmaceutical engineering at Virginia Commonwealth University’s Center for Pharmaceutical Engineering and Sciences and graduate program director for chemical and life science engineering, about how pharma manufacturing has evolved over the course of his career and where it's headed. Roper draws on decades of experience to discuss the significance of chemical engineering in small molecule manufacturing, the growing significance of quality by control, the promise and challenges of continuous manufacturing, and how emerging catalytic technologies and automation are advancing process development. He also shares why preparing the next generation of pharmaceutical scientists and engineers will be critical as traditional boundaries between small molecules, biologics, and emerging modalities continue to disappear.
Biopharmaceutical manufacturers are facing mounting pressure to scale production faster while maintaining quality and operational reliability due to the ever-expanding pipeline of therapies. Meanwhile, onshoring initiatives, increasingly complex facilities, workforce challenges, and rising demand for biologics are exposing limitations in traditional manufacturing approaches. As a result, organizations are rethinking how digital technologies, automation, and quality systems work together across the manufacturing enterprise.
In this episode of Off Script, we spoke with Jim Masso, president and CEO of Honeywell Process Automation, about the operational challenges shaping the next generation of biopharma manufacturing. The conversation explores where manufacturers continue to encounter bottlenecks when scaling production, why workforce constraints and human error remain significant contributors to quality issues, and how AI-enabled process control and integrated digital quality systems can help improve reliability and accelerate facility startup. Masso emphasized the growing importance of connecting environmental controls, automation, and quality management, and stressed the organizational changes needed to fully realize the benefits of digital manufacturing.
Amid ongoing geopolitical uncertainty, regional manufacturing initiatives, and evolving supply chain risks reshaping the pharmaceutical industry, manufacturers are rethinking how biologics are produced and delivered around the world. Rather than relying on centralized production models, many organizations are expanding regional manufacturing footprints and developing more integrated production networks designed to improve resilience, reduce operational risk, and support long-term supply continuity.
In this episode of Off Script, we spoke with Jeff Mason, VP and head of the New Jersey Sales Office at Samsung Biologics, about how CDMOs are adapting to this changing landscape. The discussion follows Samsung Biologics establishing its first U.S. manufacturing presence through the acquisition of GSK's biologics facility in Rockville, Maryland, reflecting the broader industry shift toward regional manufacturing capacity.
The conversation explores the growing importance of regional manufacturing strategies, why customers are increasingly seeking manufacturing redundancy from the outset of commercialization, how vertically integrated service models can simplify complex supply chains, and what the next generation of global manufacturing ecosystems could look like as companies balance efficiency with resilience.
As biopharma pipelines become more complex and market conditions continue to evolve, manufacturers are rethinking how they scale capacity, deploy capital, and build supply chains. The industry’s focus is increasingly shifting toward developing the flexibility, resilience, and specialized capabilities needed to support rapidly evolving therapeutic modalities. At the same time, regionalization efforts, supply chain pressures, and changing sponsor expectations are prompting both CDMOs and drug developers to reassess long-term manufacturing strategies.
In this episode of Off Script, we spoke with Sebastián Arana, executive vice president and global head of process solutions at MilliporeSigma, about the forces reshaping the biopharma CDMO landscape. The conversation explores the industry’s shift from a capacity-driven market to a capability-driven one, how sponsors’ expectations around speed and flexibility are changing manufacturing partnerships, and why process characterization, tech transfer, and supply chain coordination remain persistent scaling challenges. Arana also discusses the growing trend toward retrofitting existing facilities for multi-modality production, the rise of region-for-region manufacturing strategies, and more.
Interest in macrocyclic peptides (MCPs) continues to grow, which means manufacturers are facing mounting pressure to develop production methods capable of supporting commercial-scale demand of these molecules. While they offer a unique combination of potency, selectivity, and drug-like properties, the structural complexity of MCPs has historically made them difficult and costly to manufacture using traditional peptide synthesis techniques. As a result, new manufacturing approaches are emerging that aim to improve efficiency, scalability, and sustainability while expanding access to this promising class of therapeutics.
In this episode of Off Script, we spoke with David Thaisrivongs, executive director, head of biocatalysis at Merck, about research recently published in Science detailing a biocatalytic manufacturing process for enlicitide, an investigational oral macrocyclic peptide designed to lower LDL cholesterol. The conversation explores the limitations of conventional solid-phase peptide synthesis, how Merck leveraged enzyme-driven manufacturing and crystallization strategies to significantly reduce process complexity, and why minimizing chromatography can be critical for commercial-scale peptide production. He also discussed the broader implications of biocatalysis for manufacturing increasingly complex therapeutic modalities and how the technology could help shape the future of pharmaceutical production.
As peptide therapeutics become larger, more complex, and increasingly purity-sensitive, manufacturers are confronting a new layer of execution challenges. Long-chain peptides introduce compounding scale-up inefficiencies, increasingly fragile purification requirements, and impurity profiles that become more difficult to characterize and control at commercial scale. At the same time, growing dependence on specialized amino acids, tightly specified reagents, and globally distributed supply chains are forcing developers and CDMOs to think more strategically about how process design decisions made early in development can ultimately determine long-term manufacturability and program risk.
In this episode of Off Script, we continued our conversation with Dr. Sharadsrikar Venkatesan Kotturi, chief scientific officer at Neuland Laboratories, about the operational and technical realities shaping modern peptide manufacturing. The discussion explores why long-chain and high-purity peptides become increasingly difficult to scale reproducibly, how aggregation, impurity control, and analytical sensitivity compound across larger sequences, and why process robustness ultimately determines whether peptide programs can succeed commercially. We also examine the growing intersection between process design and supply chain resilience, including how early route selection decisions can amplify sourcing risk for protected amino acids and specialized reagents.
Peptide pipelines continue to expand globally, and pharmaceutical companies are increasingly turning to CDMOs earlier in the development lifecycle to help manage growing technical and operational complexity. Outsourcing partners are being leaned on to support process development, analytical strategy, scale-up, and regulatory readiness from the earliest stages of a program. At the same time, rising demand for peptide therapeutics is placing new pressure on manufacturing capacity, raw material availability, and technical expertise across the industry.
In this episode of Off Script, we spoke with Dr. Sharadsrikar Venkatesan Kotturi, chief scientific officer at Neuland Laboratories, about how peptide development is reshaping relationships between sponsors and CDMOs. The conversation explores why pharmaceutical companies are engaging outsourcing partners earlier in the process, the growing execution challenges associated with peptide scale-up and impurity control, and how analytical complexity, raw material sourcing, and manufacturing scalability increasingly intersect across peptide programs. Kotturi also discusses the strain these shifting expectations are placing on both sponsors and service providers, along with the operational realities of supporting early-stage peptide development.
As municipal water utilities increasingly shift from free chlorine to chloramine disinfection strategies, pharmaceutical manufacturers are facing new challenges in maintaining consistent, high-purity water systems. While chloramines provide utilities with longer-lasting residual disinfection and reduced formation of regulated byproducts, they also introduce operational risks inside pharmaceutical facilities. As a result, manufacturers are reassessing traditional chloramine removal approaches and exploring more proactive treatment strategies that improve resiliency, monitoring, and long-term operational efficiency. In this episode of Off Script, sponsored by Trojan Technologies, we spoke with Wayne Lem, global applications manager at Trojan Technologies, about the evolving role of UV technology in pharmaceutical water treatment systems. The conversation explores how chloramine shifts at the municipal level are impacting pharmaceutical manufacturing operations, the limitations of traditional approaches like catalytic carbon and reducing chemicals, and how UV-based chloramine destruction can help facilities improve process reliability while reducing maintenance and chemical dependency. Lem also discusses the operational and economic considerations behind UV adoption, the importance of continuous monitoring and validation in regulated environments, and why hybrid, multi-barrier treatment strategies are becoming increasingly important as manufacturers modernize water infrastructure.
Amid increasing complexity in the drug development landscape, CDMOs are exploring new ways to streamline the path from early-stage formulation through commercial manufacturing. Rather than operating in isolated segments of the development lifecycle, some outsourcing partners are beginning to form more integrated collaborations designed to reduce handoffs, improve coordination, and simplify the client experience across multiple stages of manufacturing.
In this episode of Off Script, we spoke with David Leroux-Petersen, CEO of Corealis Pharma, and Jean-Baptiste (JB) Agnus, CCO of the CDMO division at Bora Pharmaceuticals, about the emerging role of CDMO-to-CDMO collaboration through the lens of a new partnership between their companies. The conversation explores how integrated outsourcing models can help reduce development risk and accelerate timelines, what operational alignment looks like across organizations with complementary capabilities, and why client-centricity, governance, and transparent communication are essential in complex manufacturing partnerships.
As pharmaceutical manufacturers push forward with massive capital expansion plans, challenges go beyond simply breaking ground on new facilities—it’s also managing the growing complexity, uncertainty, and resource strain that come with executing mega-projects. Persistent supply chain disruption, extended equipment lead times, rising material costs, and workforce constraints are forcing companies to rethink how they plan, govern, and prioritize capital investments in an increasingly volatile environment.
In this episode of Off Script, we continued our conversation with Steve Cabano, president of Pathfinder, and Mark Christopher, vice president and head of the company’s pharmaceutical division, about the operational realities shaping large-scale pharmaceutical construction projects today. Pathfinder is a project management consulting firm. The discussion explores how post-pandemic supply chain instability and tariff uncertainty are impacting procurement strategies, scheduling assumptions, and project economics, with lead times for critical equipment stretching far beyond historical norms. We also examine the growing importance of portfolio-level governance as companies attempt to manage dozens of overlapping billion-dollar initiatives while maintaining existing operations, avoiding internal resource conflicts, and preparing for a future shaped by modularization, robotics, and AI-enabled project delivery.
Rising capital investment in pharmaceutical manufacturing is pushing projects to unprecedented scale, but execution strategies haven’t fully kept pace. As companies commit billions to new facilities they’re encountering a new set of challenges around planning, coordination, and risk management. What worked for smaller, site-based upgrades is insufficient for multibillion-dollar builds involving thousands of stakeholders, constrained resources, and increasingly complex regional dynamics.
In this episode of Off Script, we spoke with Pathfinder President Steve Cabano and Mark Christopher, vice president and head of the company's pharmaceutical division, about what it takes to successfully deliver mega-scale capital projects in today’s environment. Pathfinder is a project management consulting firm. The conversation explores how the industry’s shift back toward large-scale North American manufacturing is exposing gaps in project controls, contracting strategies, and organizational readiness. They discuss the growing importance of early-stage planning, clearer decision ownership, and construction-driven execution models, as well as how labor competition, permitting hurdles, utility constraints, and global procurement risks are reshaping timelines and cost structures.
Ever since the revised Annex 1 was published, drug makers have been navigating a broader transformation of sterile manufacturing that extends beyond compliance. Contamination control, in turn, is becoming a more proactive, data-driven, and highly collaborative model, one that emphasizes continuous improvement, global alignment, and deeper integration across the supply chain. While the regulation itself builds on decades of precedent, its latest iteration is accelerating expectations around risk management, documentation, and end-to-end control strategies.
In this episode of Off Script, we spoke with Haley Johnson, senior manager of product management, and Bill Matakas, vice president of business transformation at West Pharmaceutical Services, about how Annex 1 is reshaping sterile manufacturing operations and supplier relationships. The conversation explores the industry’s shift from reactive remediation to proactive risk prevention, the growing importance of contamination control strategies as living systems, and how inspectors are increasingly focused on measurable, year-over-year improvement.
As the U.S. government pushes to reshore pharmaceutical manufacturing and rein in drug pricing, the implications for CDMOs and the broader outsourcing ecosystem are coming into sharper focus. While large-scale onshoring investments dominate headlines, questions remain around how policy will account for outsourced manufacturing and whether incentives align with the realities of global supply chains.
In this episode of Off Script, we spoke with Gil Roth, founder and president of the Pharma & Biopharma Outsourcing Association (PBOA), about how recent policy developments are impacting CDMOs and their customers. The conversation explores the role of CDMOs in onshoring efforts, the economic and structural barriers to reshoring API and generic drug manufacturing, and what current tariff frameworks signal about policy priorities. Roth also discusses FDA staffing challenges, potential impacts on drug review timelines, and the broader uncertainty shaping R&D, sourcing, and investment decisions across the industry.
While fully autonomous bioprocessing is within reach, adoption remains gradual as manufacturers navigate challenges around data maturity, regulatory expectations, and operational readiness. As companies modernize, the focus is shifting toward building the digital and organizational foundations needed to enable more intelligent, scalable process control, particularly through connected systems, stronger data infrastructure, and more explainable AI models that can support real-time decision-making.
In this episode of Off Script, we spoke with Mel Radford, director, life sciences global accounts at Rockwell Automation, about the key barriers to autonomy and how companies can move from reactive operations toward predictive and closed-loop process control. The conversation explores how hybrid models combining first-principles engineering with AI can improve control performance, stability, and yield while remaining transparent and easier to validate, as well as the importance of embedding compliance, governance, and human-centered change management into next-generation control strategies.
Generic medicines account for the vast majority of prescriptions in the U.S., yet much of their underlying supply chain remains heavily dependent on foreign-sourced active pharmaceutical ingredients (APIs). As concerns around drug shortages and supply chain resilience intensify, attention is shifting upstream toward how APIs are manufactured, where they are sourced, and what it will take to rebuild domestic production capacity. At the same time, advanced manufacturing approaches like continuous flow are gaining traction as a way to improve efficiency, safety, and cost competitiveness in a traditionally low-margin market.
In this episode of Off Script, we spoke with Brian Doty, vice president of R&D and programs at the API Innovation Center (APIIC), about the structural challenges facing generic drug manufacturing and the role advanced technologies could play in addressing them. The conversation explores why API supply is often the cause of downstream drug shortages, the technical and economic limitations of traditional batch processing, and how continuous manufacturing can reduce process steps, improve control, and enable safer production. Doty also discusses the practical barriers to adoption as well as the growing role of FDA engagement programs and policy incentives in accelerating change.
Antibody–drug conjugates (ADCs) are rapidly evolving from experimental hybrid molecules into mature, platform-driven therapeutics, with the global market projected to reach $36 billion by 2029. As pipelines expand and molecular designs grow more complex, developers are rethinking how ADCs are designed, characterized, and manufactured. In this episode of Off Script, we spoke with Lonza's Sandro Holzer, PhD, director and head of development bioconjugates, and Anette Sommer, PhD, head of bioconjugates research, about how the ADC field has changed over the last several years and what is driving the next wave of innovation.
The conversation explores the industry’s shift toward standardized linker–payload platforms, site-specific conjugation, higher drug-to-antibody ratios, and emerging dual-payload ADCs aimed at overcoming tumor heterogeneity and drug resistance. Holzer and Sommer discuss how rising molecular complexity is reshaping CMC strategy, analytics, and downstream processing, and why early integration of biology, chemistry, and manufacturability is essential to de-risk development and enable scale-up. The episode also examines how ADC manufacturing paradigms are now informing adjacent bioconjugate modalities signaling a broader move toward integrated, multi-component therapeutics beyond oncology.
Cell and gene therapies (CGTs) have demonstrated transformative clinical potential, but manufacturing remains a major barrier to broader patient access. Highly manual, labor-intensive production processes limit throughput, introduce variability, and drive up costs, making it difficult to scale these therapies to meet growing demand. As the industry looks to expand access, there is increasing focus on how automation, robotics, and digitalization can enable more consistent, efficient, and scalable manufacturing without compromising the underlying biology.
In this episode of Off Script, we spoke with Edwin Stone, PhD, CEO of Cellular Origins, about the core bottlenecks constraining CGT manufacturing and how automation is beginning to address them. The conversation explores why labor remains a dominant cost driver, how process variability extends beyond patient starting material into everyday manual operations, and what it takes to transition from fragmented workflows to fully integrated, robotic production environments. Stone also discusses the importance of preserving biological integrity during automation, the role of digital data capture in improving consistency and regulatory confidence, and more.
Producing uniform drug delivery particles at scale has long presented a challenge for pharmaceutical manufacturers. Techniques that offer tight control over particle size and structure often struggle with throughput, while traditional industrial methods deliver volume but less consistency. As advanced drug delivery systems become more important for long-acting therapies and targeted treatments, manufacturers are increasingly seeking production methods that can balance precision, scalability, and reproducibility.
In this episode of Off Script, we spoke with Nathalie Pinkerton, PhD, assistant professor of the chemical and biomolecular engineering department at the NYU Tandon School of Engineering, about Sequential NanoPrecipitation (SNaP), a continuous flow technique designed to bring greater control to polymeric particle manufacturing. The conversation explores how separating particle formation into sequential mixing stages enables more predictable control over particle size and composition, the role of micromixer design in achieving consistent mixing and scale-up, and why encapsulation efficiency plays a critical role in manufacturing economics. Pinkerton also discusses the remaining steps needed to translate emerging particle manufacturing technologies from the lab into commercially viable pharmaceutical production platforms.
In this episode of Off Script, we continue our conversation on the structural vulnerabilities in the global pharmaceutical supply chain with Ronald T. Piervincenzi, CEO, USP, turning the focus toward practical strategies for strengthening the resilience of the global medicine supply chain.
Piervincenzi discusses the economic and structural barriers to rebuilding domestic capacity for APIs and key starting materials, and explains why resilience will require coordinated incentives that reward supply security rather than simply the lowest price. He also explores how advanced manufacturing approaches could help make domestic production more viable by improving efficiency and reducing environmental impact.
The conversation also examines how global quality standards can enable trusted international manufacturing networks among allied countries, and how USP’s new Resilience Center aims to bring together data, benchmarking frameworks, and stakeholder collaboration to help industry and policymakers better measure supply chain resilience.
The global medicine supply chain faces mounting strain from chronic generic drug shortages, geopolitical tensions, and heavy reliance on geographically concentrated manufacturing. Quality failures, pricing pressures, and opaque sourcing of key starting materials have exposed structural vulnerabilities that extend beyond routine disruptions to broader national security and public health risks. This episode is part one of a two-part series examining the root causes of these vulnerabilities and the structural changes needed to address them.
In this series, we spoke with Ronald T. Piervincenzi, Ph.D., CEO of the U.S. Pharmacopeia, about how these risks emerged and what it will take to build a more resilient pharmaceutical supply chain. In part one, Piervincenzi explains why generic drug shortages and national security concerns are often conflated, how extreme price erosion is driving manufacturers out of the market, and what USP’s data reveals about supply concentration, including the critical role of key starting materials sourced from countries like China and India. The conversation also dives into USP’s new Resilience Center and the strategic role it will serve in improving supply chain security.
Pharmaceutical packaging is undergoing rapid transformation as connectivity, sustainability, automation, and evolving regulatory demands reshape how medicines are protected, tracked, and delivered. From smart packaging features and prefilled injectables to e-commerce fulfillment and digital compliance systems, packaging and equipment investment decisions are increasingly tied to flexibility, data visibility, and long-term modernization.
In this episode of Off Script, we spoke with Rebecca Marquez, director of custom research at PMMI, about the association’s latest Trends and Challenges in Pharmaceutical Manufacturing white paper. The conversation explores how connected packaging technologies are strengthening relationships between manufacturers, regulators, and patients; why sustainability initiatives are advancing despite material performance and validation challenges; and how growth in biologics and prefilled injectables is driving new packaging and equipment demands. Marquez also breaks down the regulatory documentation gap between OEMs and end users, the rise of automation technologies, and more.
As biologics grow more complex, cell line development remains a key driver of speed, yield, and manufacturability. What was once a technical milestone is now a competitive differentiator, directly impacting time to Investigational New Drug (IND), cost of goods, and long-term scalability.
In this episode of Off Script, we spoke with Brett Verstak, director of cell line development at Abzena, to discuss how advanced Chinese hamster ovary (CHO)-based platforms, glutamine synthetase (GS) knockout systems, automation, and AI-driven workflows are accelerating clone selection and reducing downstream risk. The conversation explores persistent bottlenecks in hard-to-express proteins, the value of integrated upstream development models, and how smarter platform design is helping drug developers move complex biologics to the clinic faster.
As cell and gene therapies continue to deliver promising clinical results, manufacturing remains one of the biggest barriers to broader commercialization. Persistent challenges around cost, complexity, labor intensity, and vein-to-vein timelines—particularly for autologous CAR-T therapies—are limiting the industry’s ability to scale beyond niche and last-line indications. Addressing these constraints will be critical if CGTs are to move earlier in treatment paradigms and reach more patients globally.
In this episode of Off Script, we spoke with Jon Ellis, CEO of Trenchant BioSystems, about the current state of cell and gene therapy manufacturing and where the industry must go next. The conversation explores why traditional centralized manufacturing models are struggling to scale, how automation and digital batch records can significantly compress manufacturing timelines, and how emerging platforms are rethinking cell recovery, analytics integration, and starting material strategies.
The technologies are playing an increasingly central role in pharmaceutical manufacturing as companies contend with labor constraints, rising demand, and the need to modernize highly regulated operations.
In this episode of Off Script, we spoke with Alexander Shikany, executive vice president of the Association for Advancing Automation (A3), about how robotics adoption is reshaping pharma manufacturing today. The conversation explores why automation is now considered a core manufacturing strategy, where demand is emerging across the production lifecycle, how collaborative robots are gaining traction in regulated environments, and why human-in-the-loop automation remains essential for quality, compliance, and operational resilience.
As biopharma pipelines grow more complex, manufacturers are under increasing pressure to scale faster, adapt to new modalities, and build resilience into highly regulated operations. Meeting these demands means manufacturing agility is no longer just a competitive advantage, it’s a necessity. Yet, structural constraints, talent shortages, and legacy processes continue to impact progress across the industry.
In this episode of Off Script, we spoke with Iwan Roberts, vice president of technology and innovation strategy at Cytiva, for a deep dive into Cytiva’s latest Global Biopharma Index. The conversation explores why manufacturing agility remains a major industry pain point, why modalities like cell and gene therapy and mRNA are uniquely difficult to scale, and how CDMOs, digitalization, and new supplier relationships are reshaping the path forward.
In this episode of Off Script, we continue our conversation with David Grote, vice president of strategy at GrayMatter Partners, focusing on the execution challenges that will define the success of today’s pharmaceutical manufacturing investment boom.
David explores the growing tension between speed, quality, and cost as companies race to bring new facilities online, and explains how early collaboration with regulators can help accelerate validation without sacrificing compliance or long-term resilience. He also discusses the strategic decisions that separate proactive manufacturers from reactive ones, the lasting impact this investment cycle will have on U.S. manufacturing footprints, and the expanding set of options that could open new opportunities for smaller companies.
After years of volatility, pharmaceutical manufacturing is entering a new investment cycle, with hundreds of billions of dollars flowing into U.S. facilities. The surge promises expanded capacity, but also raises questions about workforce availability, infrastructure readiness, and long-term execution.
In this episode of Off Script, we spoke with David Grote, vice president of strategy at GrayMatter Partners, about what this wave of funding means in practice. The conversation explores where investment is concentrating, how competition for skilled talent is shaping project timelines, the strain on shared resources, and why flexible facility design will be critical to sustaining growth beyond today’s political and economic cycle.
Artificial intelligence is rapidly reshaping drug development by accelerating timelines, enabling more complex biologics, and changing how therapies are designed, delivered, and scaled. But as innovation speeds up, manufacturers face new challenges around delivery platforms, regulatory expectations, and operational agility.
In this episode of Off Script, we spoke with Anthony Vico, Head of Business Line, US Technology Excellence Center at Stevanato Group, about how the industry is navigating this shift. The conversation explores the evolving role of drug delivery systems, where AI and machine learning are having the most immediate impact, how advanced therapeutic modalities fit into this changing landscape, and what manufacturers must do to remain competitive.
While pharma supply chains are becoming increasingly digitized, the cold chain segment continues to face major vulnerabilities, from aging infrastructure and equipment failures to new refrigerant regulations. As manufacturers work to protect temperature-sensitive products and avoid costly disruptions, predictive monitoring is emerging as a critical tool for strengthening resilience.
In this episode of Off Script: A Pharma Manufacturing Podcast, we spoke with Laurie and John Masiello, co-founders of Predictive Monitor, about how predictive maintenance solutions are helping pharma manufacturers prevent downtime, extend the life of cold chain assets, and safeguard product integrity.
In this episode of Off Script, we continue our conversation with Jason Bock, co-founder and CEO of CTMC, diving deeper into the operational and manufacturing challenges shaping the future of curative cell therapies.
Jason discusses how CTMC—through its partnership with MD Anderson Cancer Center—is eliminating inefficiencies across development timelines to significantly accelerate clinical progress without increasing risk. He also shares a forward-looking perspective on how cell therapies could one day be ordered and delivered like traditional pharmaceuticals, and what scientific, regulatory, and manufacturing innovations will be required to make that vision a reality.
Autologous cell therapies have shown the promise of single-dose, curative treatments for patients with advanced cancers. But even with major scientific and regulatory progress, the field now faces its toughest challenge yet: achieving sustainable, scalable manufacturing for highly personalized therapies.
In this episode of Off Script, we spoke with Jason Bock, co-founder and CEO of CTMC, a purpose-driven cell therapy accelerator. Jason discusses why scale remains the central barrier for autologous therapies, the significance of CTMC’s partnership with MD Anderson Cancer Center, and how fit-for-purpose manufacturing models can shorten vein-to-vein time and bring transformative treatments to patients faster.
Flow chemistry and modular continuous platforms are gaining momentum as pharma searches for faster, more flexible, and more sustainable ways to develop and scale small-molecule processes. Yet questions around integration, scale-up, and regulatory expectations continue to influence how quickly these technologies can be fully adopted.
In this episode of Off Script, we spoke with Hovione’s Christoph Brücher and Microinnova’s Dirk Kirschneck about their collaboration on advancing flow chemistry and continuous manufacturing. They discuss how plug-and-play modular systems can accelerate process transfer, streamline scale-up, and reduce waste and energy use, as well as how digital tools and regulatory guidance under ICH Q13 are shaping the next generation of continuous manufacturing.
In this episode of Off Script, we continue our conversation with John Murphy III, president and CEO of the Association for Accessible Medicines, to dig deeper into the vulnerabilities and structural challenges shaping U.S. generic and biosimilar drug production.
Murphy examines the most fragile links in the supply chain — from the lack of domestic API production to key starting-material constraints — and explains why long-term, coordinated policy action is essential for restoring supply chain resiliency. He also outlines the legislative, regulatory, and market reforms that could strengthen domestic capacity without compromising patient access or affordability.
In this episode of Off Script, we spoke with John Murphy III, president and CEO of the Association for Accessible Medicines, about the forces shaping the future of U.S. generic and biosimilar manufacturing.
Murphy provides a high-level look at the pivotal shifts defining the generic drug landscape and breaks down the economic realities driving drug shortages, the complexities of global ingredient sourcing, and the policy reforms needed to build a more resilient domestic supply chain.
While the cell and gene therapy space represents one of the most exciting therapeutic frontiers in modern biopharma by offering highly personalized, transformative treatments, the sector still faces significant hurdles before it can achieve widespread commercialization. From steep manufacturing costs and a lack of standardization to persistent inefficiencies in scaling production, the road to maturity remains complex.
In this episode of Off Script: A Pharma Manufacturing Podcast, we spoke with Sharon Anderson, VP of Scientific Affairs, Alliance for Regenerative Medicine, about what’s driving progress in CGT manufacturing and where the industry is still lagging.
In part two of our conversation with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, we explore how today’s CDMO funding trends are shaping the next phase of growth and specialization across the contract research and manufacturing ecosystem.
Brian shares his perspective on:
- The outlook for cell and gene therapies, where clinical setbacks, overcapacity, and high costs are balanced by steady innovation and cautious optimism;
- Why “specialization over scale” is defining the next wave of CDMO success, as niche providers in radiopharma, peptides, and other complex modalities gain traction; and
- How the evolving Biosecure Act and U.S. reshoring efforts are reshaping global supply chains and creating new opportunities for domestic manufacturing.
As we near the end of 2025, the CDMO industry finds itself at a pivotal financial and strategic juncture — shaped by constrained funding, shifting demand, and renewed investor scrutiny.
In this episode of Off Script, we speak with Brian Scanlan, Advisor of Life Sciences at Edgewater Capital Partners, to examine how the year’s market and investment trends align with his predictions from an earlier CPHI Annual Report.
Brian shares his perspective on:
- How accurately his forecast of stability and growth for clinical CROs and CDMOs has held up amid tighter capital markets;
- The ongoing softness among early-stage pharma service providers and what it reveals about funding flows across the sector; and
- Where investor interest is gravitating — from ADCs and small molecules to biologics — and what this signals for the next phase of CDMO evolution.
This episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Jana Falkenberg, senior legal counsel and corporate compliance officer at Vetter Pharma, a global contract development and manufacturing organization (CDMO) headquartered in Germany.
Falkenberg, who is responsible for the continuous improvement of the compliance management system at Vetter, makes the case that corporate compliance encompasses legal, ethical, and internal standards. At Vetter, which this year is celebrating its 75th anniversary, building trust and fostering an environment of integrity is a critical component of the company’s culture and operations as a family-owned business.
This episode is sponsored by Vetter Pharma.
Building on insights from CRB’s Horizons: Life Sciences 2025 report, this second installment of our conversation with Peter Walters, Fellow of Advanced Therapies at CRB, explores the modalities driving forward momentum across the life sciences industry, the expanding role of standardization in manufacturing networks, and how tariffs and domestic investment strategies are shaping the future of pharma manufacturing.
If you missed Part One, catch our discussion on the rise of continuous manufacturing and its growing adoption across large pharma.
Based on insights from CRB’s Horizons: Life Sciences 2025 report, this episode of Off Script: A Pharma Manufacturing Podcast features a conversation with Peter Walters, Fellow of Advanced Therapies at CRB. Walters discusses how the industry is advancing toward continuous manufacturing, highlighted by a key finding from the report — 65% of large companies are pursuing end-to-end continuous manufacturing.
This is part one of a two-part series. In part two, dropping Oct. 14, 2025, Walters will return to explore advanced therapies, tariffs, and regulatory changes shaping the global pharma manufacturing landscape.
Large biopharma companies in recent months have pledged billions of dollars in capital expenditures for U.S. manufacturing and R&D facilities. What if it’s not accurate?Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/editors-review/article/55314470/editors-review-it-matters-if-big-pharma-is-fudging-its-us-investment-numbers
The wildly popular drugs, prescribed for weight loss and type 2 diabetes, are putting a strain on the capabilities of contract development and manufacturing organizations.Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/sector/contract-manufacturing/article/55314756/can-cdmos-keep-up-with-the-increasing-demand-for-glp-1-medications
While the agency’s PreCheck regulatory framework is a good first step, it remains to be seen whether the program boosts U.S. drug manufacturing, says former FDA official.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55309136/fdas-program-to-speed-up-us-manufacturing-buildouts-is-short-on-detail
The Garden State, called the “medicine chest” to the world, continues to show robust activity with life sciences firms accounting for nearly 30% of all Q2 leasing activity.Greg Slabodkin Read by Brittany Duncan https://www.pharmamanufacturing.com/all-articles/article/55308250/new-jersey-remains-hot-life-sciences-hub-despite-macroeconomic-funding-headwinds
Generics, which make up approximately 90% of prescription volume in the U.S., are produced primarily in India as Hikma looks to onshore production of these critical drugs.Greg Slabodkin
Read by Brittany Duncan
https://www.pharmamanufacturing.com/all-articles/article/55302441/hikmas-planned-1b-us-investment-comes-at-critical-time-for-generic-medicines-supply
While macroeconomic uncertainty weighs on the sector, there are glimmers of hope in some areas of pharmaceutical outsourcing and services.Greg Slabodkin
Read by Brittany Duncan
Read Article Here: https://www.pharmamanufacturing.com/editors-review/article/55299879/editors-review-is-the-biopharma-industrys-glass-half-empty-or-half-full
Smart manufacturing is “nearly universal” with 95% of manufacturers saying they are using or evaluating smart technology, according to a new survey from Rockwell Automation.
Greg Slabodkin
Read by Brittany Duncan
While the pharmaceutical industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum.Greg Slabodkin
Read by Brittany Duncan
Enjoy the article Here: https://www.pharmamanufacturing.com/all-articles/article/55295669/flow-state-the-evolving-shape-of-continuous-manufacturing
Hydrogenation can serve as a critical link in chemical synthesis, particularly between nitration and phosgenation. When integrated strategically, it helps enable safer, more efficient production processes.
To better understand this connection, we spoke with Dr. Luca Mantilli, R&D Chemist at Valsynthese, the fine chemicals division of Société Suisse des Explosifs Holding (SSE). Dr. Mantilli discussed how hydrogenation was implemented to bridge the gap between two of the company’s core hazardous chemistries: nitration and phosgenation.
Learn more about Valsynthese: https://www.valsynthese.ch/
The three Big Pharma companies on their earnings calls this week tried to reassure investors that they have the global footprints to mitigate the effects of tariffs.
The good — Thermo Fisher opens center to boost cell therapy development
The bad — FDA cites Aurobindo plant after Raleigh inspection
The ugly — Trump probes pharma imports as tariff threat looms
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Novartis to invest $23B in U.S. manufacturing and R&D, including seven new sites
The bad — U.S. urged to invest $15B to counter China’s biotech rise
The ugly — Trump signals ‘major’ tariffs on pharma, urging manufacturing shift back to U.S.
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Cellares, Cabaletta validate automated CAR T production
The bad — FDA warns Aspen over sterility issues
The ugly — FDA rejects Hengrui, Elevar cancer combo again
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Axplora expands its antibody-drug conjugate (ADC) manufacturing capacity to support growing demand.
The bad — Merck KGaA’s CDMO business reports a decline
The ugly — The FDA issues a warning letter to Granules India over manufacturing violations
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad, and one ugly. Up this week:
The good — Eli Lilly expands manufacturing to boost supply
The bad — FDA blocks imports from two Indian API makers over manufacturing violations
The ugly — ICU Medical recalls potassium chloride injection bags over labeling error
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Novartis boosts Slovenia investment to $3.6B
The bad — Trump tariffs unsettle biopharma FDI
The ugly — FDA warns Global Calcium, blocks US imports
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Opdivo subcutaneous version
The bad — Marinus Pharmaceuticals sells operations
The ugly — Novo Nordisk pushes back against compounding pharmacies
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — EU approves Novo-Catalent acquisition
The bad — CDMO National Resilience announces layoffs
The ugly — FDA investigates blood cancer reports in gene therapy patients
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Imkeldi oral solution
The bad — Alector axes workforce
The ugly — Novartis announcnes layoffs
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA grants Regenxbio accelerated approval pathway for Duchenne gene therapy
The bad — Neurogene reports patient death in Rett syndrome gene therapy trial
The ugly — Halozyme withdraws acquisition proposal for Evotec
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — PTC secures FDA nod for brain-targeted gene therapy
The bad — Kronos Bio halts CDK9 development
The ugly — Marinus slashes 45% of workforce amid setbacks
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Ascendis, Novo ink partnership
The bad — Court blocks Sun Pharma launch
The ugly — FDA moves to delist phenylephrine
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — MilliporeSigma expands ADC manufacturing
The bad — EU fines Teva
The ugly — AZ exec under investigation
Join senior editor Andrea Corona and Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO), as they discuss the urgency of tackling antimicrobial resistance and the coordinated global efforts needed to save the struggling market of antibiotics.
Extended Release is an Off Script series to revisit conversations with our sources and explore new developments, gain deeper insights, and provide updates on the impact of their work.
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Nucleus RadioPharma expands production with new sites
The bad — FDA issues CRL to Camurus' hormone disorder drug
The ugly — NHS rejects Alzheimer's drug over cost concerns
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves AbbVie 24-hour Parkinson’s treatment
The bad — Sage Therapeutics axes workforce
The ugly — FDA halts Novavax's COVID-flu vaccine trials
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Roche snags breast cancer FDA nod
The bad — FDA places clinical hold on Kezar lupus nephritis drug trial
The ugly — FDA rejects Zealand Pharma hypoglycemia drug over manufacturing reinspection
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Gilead inks deal with generics manufacturers to expand HIV drug access
The bad — J&J announces layoffs at New Brunswick headquarters
The ugly — Amgen sued for hiding $10.7B tax bill
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good —FDA approves BMS schizophrenia drug
The bad — bluebird bio announces layoffs
The ugly —J&J talc subsidiary files for bankruptcy
Join senior editor Andrea Corona and Sam Clark, CEO and founder of Terran Biosciences, for a discussion on KarXT's landmark approval, schizophrenia treatment barriers, prodrugs, and more.
Extended Release is an Off Script series that allows us to revisit conversations with our sources to explore new developments, gain deeper insights, and provide updates on the impact of their work. Each episode goes beyond the initial story, offering a richer understanding of key topics and ongoing innovations in the pharma industry.
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Novo Nordisk shares phase 2a trial data for obesity treatment
The bad — Achilles Therapeutics to discontinue TIL-based therapy
The ugly — Express Scripts files lawsuit against FTC
Drugmakers face stringent regulations to ensure that products remain free from contaminants that could compromise safety and efficacy. Effective contamination control requires meticulous monitoring of environmental conditions, rigorous testing of products, and implementation of robust cleaning and sterilization procedures.
To better understand these challenges, we sat down with Emily Alkandry, analytical services and quality control manager and Gabrielle Wilson, sterility assurance program manager at Saint-Gobain Life Sciences about the importance of comprehensive contamination control strategies for ensuring product quality and regulatory compliance.
Learn more about Saint-Gobain Life Sciences: https://www.lifesciences.saint-gobain.com/
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Roche snags FDA nod for subcutaneous cancer immunotherapy
The bad — Moderna to cut R&D expenses by $1.1B
The ugly — Teva reaches $80M opioid settlement with Baltimore
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Pfizer, Valneva share phase 2 positive Lyme vax data
The bad — IN8bio axes workforce, halts trial
The ugly — AstraZeneca employees detained in China
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Illumina cancer biomarker test
The bad — BioMarin reveals more layoffs
The ugly — FDA hits API maker Global Calcium with 483
The concept of healthspan has recently gained new attention in the pharma industry and rightfully so, given the surprisingly large chasm in the U.S. between average years lived (77.5) and average years lived in good health (63.9). Facing a growing demographic of unhealthy seniors, a handful of innovative biotechs are reframing the longevity discussion: Rather than treat the symptoms of aging one disease at a time, what if we could instead focus on the root causes, enabling treatment of multiple chronic diseases simultaneously?
During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, discussing the compelling new research and novel genetic medicines that may help close the gap between healthspan and lifespan.
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Emergent donates 50,000 doses of mpox vaccine to Africa
The bad — FDA rejects Regeneron blood cancer bispecific antibody
The ugly — China indicts Astellas exec for espionage
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Ascendis hypoparathyroidism drug
The bad — FDA rejects Lykos MDMA PTSD drug
The ugly — Judge blocks Novartis bid to stop generic blockbuster heart drug
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly.
Up this week:
The good — Amneal gets FDA nod for Parkinson’s pill
The bad — Novo Nordisk withdraws bid for Wegovy label expansion in heart failure
The ugly — FDA delays decision on BeiGene Tevimbra as a first-line therapy
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Adaptimmune engineered cell therapy
The bad — FDA puts clinical hold on vTv Therapeutics diabetes program
The ugly — Sanofi sues Sarepta over manufacturing patents for Duchenne gene therapy
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Sun Pharma hair loss drug
The bad — FDA issues harsh warning letter to Indian CDMO Brassica
The ugly — EMA issues negative opinion on Eisai-Biogen Alzheimer's drug
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Genentech's oral weight loss drug shows promise
The bad — FDA denies accelerated approval for Agenus' cancer drug
The ugly — Orexo's opioid overdose drug rejected again
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Pfizer advances once-daily obesity pill
The bad — FDA rejects Novo Nordisk once-weekly insulin
The ugly — FTC releases long-awaited report on PBMs
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA grants Eli Lilly Alzheimer’s drug full approval
The bad — FDA rejects Rocket gene therapy
The ugly — Eisai, BMS end ADC partnership
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Verona wins FDA nod for COPD
The bad — FDA issues CRL to Merck-Daiichi lung cancer ADC
The ugly — Glenmark recalls 114 batches of potassium chloride capsules
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Gilead twice-yearly HIV shot delivers zero infections in trial
The bad — Takeda epilepsy drug misses endpoints in trials
The ugly — Eli Lilly goes after counterfeiters
By integrating a Quality by Design (QbD) approach, developers can design robust packaging from the outset, drastically reducing development time and costs. Understanding how moisture affects a product is key, allowing developers to use industry-accepted and validated models to predict and address potential stability issues early in the design phase, thereby reducing the need for prolonged probe stability testing and potential reformulations or packaging redesign.
To understand more about the issues at hand, senior editor Andrea Corona recently spoke with Adrian Possumato, president and Chris Gilmor, director of sales, at Sanner of America.
Learn more about Sanner of America: https://www.sanner-group.com/
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA AdComm backs Eli Lilly Alzheimer’s drug
The bad — Pfizer gene therapy fails phase 3 Duchenne trial
The ugly — Talc plaintiffs seek restraining order on J&J bankruptcy tactic
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — AstraZeneca’s Tagrisso delivers 84% progression-free survival in trial
The bad — BMS to let go of 863 employees at NJ site
The ugly — FDA inspection uncovers multiple violations at Jiangsu Hengrui Pharmaceuticals site
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — J&J depression drug aces late-stage trial
The bad — Takeda plans layoffs at Massachusetts sites
The ugly — FDA delays review of Sanofi-Regeneron's Dupixent in COPD
When the pandemic hit and Americans found themselves looking to China for critical medical supplies, the idea of reshoring — a concept that had drifted along the currents of the manufacturing sector for over a decade — embedded itself into pharma discourse with renewed luster.
During this podcast, Chief Content Director Karen Langhauser will share a summary of our most recent cover story, Mining pharma's reshoring rush, and discuss where the industry stands amid the U.S. movement to bring the manufacturing of generic drugs, APIs and ingredients home.
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves first interchangeable biosims to Regeneron Eylea
The bad — Evotec exits gene therapy
The ugly — J&J reports deaths in early-stage radioligand trial
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Amgen T-cell engager for small cell lung cancer
The bad — BioMarin announces 170 layoffs
The ugly — FDA delays review of Ascendis hypoparathyroidism drug
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Vertex submits NDA for CF drug
The bad — MacroGenics reports patient deaths in prostate cancer ADC trial
The ugly — FTC extends review of Novo-Catalent deal
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Neurocrine wins FDA nod for 'sprinkle' Ingrezza formulation
The bad — Moderna, Metagenomi end gene editing collab
The ugly — Emergent announces layoffs, closes sites
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Novartis wins rare cancer pediatric indication for Lutathera
The bad — BMS unveils cost-saving initiative, layoffs
The ugly — McKinsey under fire for alleged role in opioid crisis
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — GSK antibiotic hits phase 3 goals in gonorrhea
The bad — Genentech ends $3B Adaptimmune T-cell collab
The ugly — Par Pharmaceutical recalls Treprostinil injection for potential contamination
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — BMS schizophrenia drug shines in phase 3 trial
The bad — Novartis to axe 680 jobs
The ugly — Lilly compounding suit dismissed
Politics, whether we like them or not, weigh heavy on manufacturing’s future.
In case you haven’t heard, it is an election year! Which means, global trade, regulations, immigration, national security and taxation will all be part of the national discourse, and all of those topics touch on manufacturing in one way or another.
During this podcast, we will share a discussion courtesy of our sister brand, IndustryWeek, as part of their livestream program, Production Pulse. The broadcast features insights from Pharma Manufacturing’s chief content director Karen Langhauser as well as from editors on Machine Design and Food Processing.
Editor's Review: Week of April 1
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Basilea Pharmaceutica receives FDA approval for its IV antibiotic
The bad — Verve Therapeutics halts gene editing trial, again
The ugly — Amylyx removes ALS treatment from market
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — FDA approves Akebia Therapeutics' Vafseo anemia drug
The bad — Bristol Myers Squibb's Crohn's disease drug disappoints
The ugly — FDA rejects Regeneron Pharmaceuticals lymphoma treatment
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Orchard gene therapy wins first FDA nod for rare pediatric disease
The bad — Abiomed recalls heart pump instructions due to perforation risks
The ugly — J&J files lawsuit against a former employee for allegedly taking over 1,000 files to Pfizer
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Madrigal wins first FDA nod for NASH
The bad — Acadia abandons plans to expand pimavanserin indications
The ugly — BIO backs BIOSECURE Act, boots WuXi
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Boehringer Ingelheim to cap out-of-pocket inhaler prices
The bad — Amylyx ALS drug falls short in phase 3 trial
The ugly — FDA delays Eli Lilly Alzheimer's drug decision with last-minute AdComm
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Iovance has launches Amtagvi
The bad — FDA rejected Theratechnologies HIV instramuscular injection
The ugly — BioMarin receives a subpoena from the DOJ
Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:
The good — Amtagvi approval
The bad — Rapt clinical hold
The ugly — Novavax and Gavi settlement
Across the board, the pharma industry is facing sky-high pressures to bring drugs to market quickly, safely and affordably. Facing this daunting landscape, pharma companies are enlisting the help of focused contract manufacturers to shape their therapies from the ground up. CDMOs, who so often go unnamed and unsung, have now become integral to forging the future of pharma.
During this podcast, Chief Content Director Karen Langhauser will introduce you to the four promising CDMOs we’ve chosen to profile in our March issue — ten23 health, Cellares, INCOG BioPharma Services and Matica Biotechnology.
Launching a new company into a crowded contracting space isn’t for the faint of heart — it demands expertise, ingenuity and a willingness to embrace risk. Fortunately, a new generation of CDMOs are boldly positioning themselves to become pillars of pharmaceutical progress.
In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Derek Duncan Product Line Director, at Lighthouse Instruments to discuss the significance of CCI and the evolving landscape of CCI testing, regulatory guidance, and the unique considerations posed by innovative therapies with extreme storage and transport requirements.
Read the transcript: https://www.pharmamanufacturing.com/home/article/33011904/solutions-spotlight
Learn more about Lighthouse instruments: https://lighthouseinstruments.com/
In this latest episode of Off Script: A Pharma Manufacturing Podcast, Karen Langhauser is joined by Veronica Ghidotti Product Manager, Visual Inspection Systems at Stevanato Group, to discuss how pharma markets have shifted towards drugs that require syringes and vials — which are historically difficult to inspect — and how new automatic inspection solutions can help.
Read the transcript: https://pharmamanufacturing.com/33009598
Learn more about Stevanato Group: https://www.stevanatogroup.com/en/
In this latest episode of Off Script: A Pharma Manufacturing Podcast, Andrea Corona is joined by Daniel Price, director and head of excipients, solid applications at MilliporeSigma, to discuss his work driving innovation in the fields of 3d printing of oral solid dosage forms, next generation pharmaceutical manufacturing, oral delivery of novel modalities and predictive formulation, and how these innovations can help overcome today's drug formulation challenges.
Read the transcript: https://pharmamanufacturing.com/21438233
For those in the pharmaceutical industry, the recent challenge has been in figuring out how to extend the digital capability of our everyday lives into pharma asset management. How do you bring all of a plant's activities and the data behind them into one place? Furthermore, if you could do that, what benefits would it bring to asset management? Karen Langhauser is joined by Ethan Smith, general manager of Life Sciences for Nuvolo, to get a better understanding of how pharma can bring its asset management into the digital age.
Learn more about Nuvolo: https://www.nuvolo.com/
Read the transcript: https://pharmamanufacturing.com/21436830
Ophthalmic drug formulation and manufacturing brings with it unique challenges and regulatory requirements. To discuss methods to overcome these challenges, Pharma Manufacturing Senior Editor Andrea Corona speaks with Smita Rajput, field marketing manager at MilliporeSigma.
Learn more about MilliporeSigma: https://www.emdmillipore.com/US/en
Read the transcript: https://pharmamanufacturing.com/21436478
The digitalization journey for pharmaceutical manufacturing can reap many benefits and there are many choices to be made in terms of these technologies and how to deploy them. In this episode, Andrea Corona talks about how digitalization is delivering a competitive advantage and assembly and inspection with Veronica Ghidotti and Fabio Bertacchini from Stevanato Group.
Learn more about Stevanato Group: https://www.stevanatogroup.com/en/
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/how-digitalization-can-provide-a-competitive-advantage
Predictive maintenance can help pharma companies can capture enormous value. Digital solutions can help eliminate downtime, reduce maintenance costs and maximize productivity, ultimately unlocking the capacity that is necessary to get the highest quality product to patients who need them most. Senior editor Andrea Corona discusses this with Zach Gilulah, pharma machine health lead at Augury
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/stop-the-stall-the-time-is-now-for-predictive-maintenance-in-pharma
Endotoxin testing serves a vital function in pharma quality control by ensuring that products are safe for patients. But the traditional approach to Bacterial Endotoxins Testing (BET) is an area ripe for disruption and improvements. Now, the Sievers Eclipse BET platform by Suez offers new levels of automation, compliance and sustainability, ushering in the next generation of BET.
Learn more about Suez: https://www.suezwatertechnologies.com/
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-a-groundbreaking-approach-to-bet-testing
In pharma, the use of gas analysis in fermentation bioreactors is critical for monitoring the health of a culture, and measuring small changes to oxygen and carbon dioxide concentrations at key phases of the process. Whether using continuous or batch fermentation for bacterial, microbial or mammalian cell culture expression, Thermo Fischer Scientific's gas analysis mass spectrometry product range provides precise off-gas analysis through every stage of fermentation. To learn more about the Prima BT and Prima PRO models, senior editor Meagan Parrish chats with Daniel Merriman, strategic marketing manager, Thermo Fischer.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-gas-analysis-mass-spectrometer-applications-in-fermentation-and-cell-culture-process
RNA-based vaccines have played a starring role in the ongoing COVID-19 pandemic and there is great potential for RNA to be applied to further indications. But nucleic acids are highly negatively charged and fragile and the right delivery systems are needed to protect RNA from degradation. One technology — lipid nanoparticles — has proven to enable the drug delivery of RNA-based therapeutics. Karen Langhauser and MilliporeSigma’s Dr. Estelle Beguin discuss lipid nanoparticles and the role they will play in the success of emerging therapies and vaccines.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-special-delivery-lipid-nanoparticles-usher-in-new-treatments
Poor ergonomics have been linked to a host of physical problems and can have an impact on workplace efficiency. Improving posture and physical habits has been linked to increased worker productivity and reduced errors. A reduction in injuries also saves money for companies, and helps businesses retain healthier and happier employees. However, many companies might overlook this aspect of workplace safety and this is where artificial intelligence can come to the rescue. Meagan Parrish and Blake McGowan, Director of Ergonomics Research for VelocityEHS, discuss.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solutions-spotlight-harnessing-ai-to-improve-workplace-ergonomics
Many inside and outside of the pharma industry think so. Now, one group is putting pressure on the FDA and Congress to move pharma away from animal modeling in drug development.
Learn more about the White Coast Waste Project: https://www.whitecoatwaste.org/
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/is-it-time-to-call-the-dogs-off-drug-testing
When doctors administer treatments to patients, some amount of drug is often left behind in the vial. What happens next? It gets tossed. Now, Congress is taking a closer look at this issue and considering new policies aimed at reducing this kind of medical waste.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/drugs-down-the-drain
The importance of quality in pharma manufacturing can't be overstated. Fortunately, the industry has stepped up drug quality. While much of this can be attributed to better science and clearer guidance, technology improvements — like the application of AI to visual inspection equipment — have potential. Chief content director Karen Langhauser and Giacomo Girotto, vision inspection project manager for Stevanato Group discuss.
Learn more about Stevanato Group: https://www.stevanatogroup.com/en/
Read the full transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/solution-spotlight-elevating-quality-inspection-with-ai
If Biogen’s controversial aducanumab is approved, it could become the best-selling drug of all time — and it’s a drug that has only shown modest efficacy. Here’s more on why the Alzheimer’s pipeline is primed for such a remarkable situation.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/inside-the-fdas-fateful-alzheimers-decision
The complex development and manufacturing processes needed to bring biologic drugs to market almost always translates into exorbitant prices, even after the drugs go off patent. Consequently, many areas of the world simply do not have access to the accepted standard of care. Chief content director Karen Langhauser sat down with the founders of Phylloceuticals to discuss how they plan to change this.
Learn more about Phylloceuticals at http://phylloceuticals.com.
Read the transcript: https://www.pharmamanufacturing.com/podcasts/off-script-a-pharma-manufacturing-podcast/growing-the-biologic-drug-supply/
What has allowed the government to — for once — move at the speed of industry to help curb the pandemic? And will the FDA be able to maintain this pace once the pandemic winds down?
We caught up a long-time regulatory expert to find out.
Read the transcript.
Pharma stepped up to the plate this year to deliver vaccines in record time and desperately needed therapeutics. Will these historic achievements change the industry's reputation in the eyes of the public? Chief Content Director, Karen Langhauser, and Senior Editor, Meagan Parrish, take a look back at pharma's accomplishments — and stumbles — during the pandemic.
Read the transcript .
Audio clips used:
CNBC: "How pharmaceutical companies are responding to the coronavirus outbreak"
CNA: "Pharmaceutical companies scramble to produce coronavirus vaccine"
CNBC: "The Race To Develop A Coronavirus Vaccine"
CBS News: "Trump to meet with pharmaceutical CEOs amid growing coronavirus outbreak"
CNBC: "Trump meets with big pharma to tackle coronavirus"
CBNC: "Moderna CEO Stephane Bancel on executive stock sales"
The threat of superbugs hasn’t gone away and in many ways the pandemic has made this problem loom even larger. But a new organization called the AMR Action Fund is working to infuse needed dollars and resources into the dwindling pipeline for needed antibiotics.
Read the full transcript
As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.
Read the transcript here: https://bit.ly/34PEeb6
Chief Content Director Karen Langhauser is joined by Richard Wood, Executive Director of Technical Solutions at Softbox Systems. Read the full transcript: https://bit.ly/2JaQOsQ Learn more: https://bit.ly/2G8oWo3
It's been called the biggest logistical challenge of all time. What does pharma and the government need to do to quickly and successfully deliver COVID-19 vaccines into the waiting arms of Americans? Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out.
Read the full transcript here: https://bit.ly/3dJdhZs
Should America reshore more generic drug manufacturing? Will it really keep our supply chains safe from disruptions? For our September cover story, we took a deep dive into these questions to untangle the arguments around reshoring generic drug production. Find out why we walked away so obsessed with Rosemary Gibson and why Phlow Corp. might be the company that settles the debate around reshoring once and for all.