Off Script: A Pharma Manufacturing Podcast

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.