Off Script: A Pharma Manufacturing Podcast

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 ...

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 deve...

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 d...

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 seekin...

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 wh...

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 ...

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 moderniza...

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 o...

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...

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 exp...

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 S...

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 acc...

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 o...

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 Ce...

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 Manufact...

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 s...

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. J...

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 Kirs...

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, coo...