Off Script: A Pharma Manufacturing Podcast

Pharma Manufacturing
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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!

  1. 2 DNI TEMU

    Why Cell Line Development Determines Biologics Success

    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.

    14 min

  2. 10 LUT

    Designing CGT Manufacturing for Scale, Speed, and Access

    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.

    20 min

  3. 3 LUT

    Robotics and Automation in Pharma Manufacturing

    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.

    19 min

  4. 27 STY

    Manufacturing Agility in a Changing Biopharma Landscape

    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.

    18 min

  5. 20 STY

    Understanding Pharma Manufacturing’s Domestic Investment Surge: Part Two

    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.

    10 min

  6. 13 STY

    Understanding Pharma Manufacturing’s Domestic Investment Surge: Part One

    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.

    17 min

  7. 6 STY

    AI and the Future of Drug Development

    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.

    24 min

  8. 30.12.2025

    Predictive Maintenance for a Modern Cold Chain

    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.

    15 min
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O programie

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!

Informacje