Off Script: A Pharma Manufacturing Podcast

As drug development grows increasingly complex, 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 manufact...

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, an...

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, constraine...

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 preceden...

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...

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 ...

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...