Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturing
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  • 两周一更

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!

  1. 3天前

    How the Framework of Modern Pharma Manufacturing Is Being Rebuilt: Part One

    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.

    22 分钟

  2. 6月30日

    Accelerating Biopharma Manufacturing Through Integrated Automation

    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.

    21 分钟

  3. 6月23日

    The Future of Global Biopharma Manufacturing Networks

    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.

    12 分钟

  4. 6月16日

    Building Flexibility into Biopharma Manufacturing

    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.

    20 分钟

  5. 6月9日

    How Biocatalysis Is Changing Pharma Manufacturing

    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.

    19 分钟

  6. 6月2日

    How Peptide Development Complexity Is Reshaping CDMO Partnerships: Part Two

    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.

    21 分钟

  7. 5月26日

    How Peptide Development Complexity Is Reshaping CDMO Partnerships: Part One

    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.

    20 分钟

  8. 5月22日

    Solutions Spotlight: Managing Chloramines in Pharmaceutical Water Systems

    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.

    18 分钟
查看全部 130 集

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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!

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