Off Script: A Pharma Manufacturing Podcast

The FDA recently announced the participants in its PreCheck pilot program, an initiative designed to encourage earlier collaboration between regulators and companies developing new domestic pharmaceutical manufacturing facilities. By shifting facility readiness discussions earlier in the development process, the program aims to improve regulatory predictability, reduce manufacturing risk, and accelerate commercial launches, an approach that could be particularly valuable for advanced manufacturing technologies and complex therapeutic modalities like cell therapy.

In this episode of Off Script, we spoke with Fabian Gerlinghaus, co-founder and CEO of Cellares, about the company's selection as one of seven participants in the inaugural PreCheck cohort and what the program could mean for both Cellares and the future of cell therapy manufacturing. The conversation explores how earlier regulatory engagement will help de-risk commercial launches, why automation is changing the scalability of autologous cell therapies, and how standardized manufacturing platforms may enable faster global tech transfer. Gerlinghaus also discusses Cellares' strategy for building a global network of automated manufacturing facilities, the company's recent fundraising efforts to support its expansion, and the milestones—including a planned IPO—that will shape its next phase of growth.

As pharmaceutical manufacturers work to reduce energy consumption and meet sustainability targets, attention is expanding beyond core production processes to the utility systems that support manufacturing. Steam systems, which play a critical role in sterilization, heating, and HVAC operations, can account for a significant share of a facility's energy consumption. Yet things like manual inspection practices and undetected steam trap failures often leave manufacturers with unnecessary energy losses, higher emissions, and increased operating costs.

In this episode of Off Script, sponsored by Emerson, we spoke with Tom Belling, global director of Life Sciences at Emerson, about the growing role utilities play in pharmaceutical sustainability strategies, and the significance of steam systems within that. The conversation explores why steam systems have become an important opportunity for improving operational efficiency and how continuous monitoring technologies are helping manufacturers identify failures earlier without disrupting operations. Belling also discusses how wireless sensing, acoustic monitoring, and data-driven maintenance can improve reliability, support sustainability, and reduce maintenance costs while protecting product quality.

The advancement of pharmaceutical manufacturing depends heavily on the research taking place in areas such as continuous manufacturing, automation, machine learning, and AI. The maturation of these technologies will foster improved process optimization, accelerate the development of medicines, and make manufacturing more efficient and reliable.

This is the second part of our conversation 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. Roper discusses how graduate students in his research group have helped advance technologies ranging from computational fluid dynamics and process analytical technology to machine learning applications for process optimization. He also shares why he views AI as a powerful tool, not a replacement for people, and how it’s preparing the next generation of scientists and engineers.

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.

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. 

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.

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.

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.

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.

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.