Off Script: A Pharma Manufacturing Podcast

The pipeline of biologic products entering the market is becoming increasingly complex, and biomanufacturers are incorporating newer technologies and manufacturing strategies into their processes to meet unique production needs. CDMOs, for example, are developing advanced platforms to improve their adaptability and flexibility as the biologics market continues to grow and evolve. In this episode of Off Script, we spoke with Randal Bass, executive vice president of process design and innovation for Just-Evotec Biologics , a Seattle-based CDMO specializing in the development and manufacturing of biologic products. The conversation explored the challenges of meeting the demands of an expanding but increasingly fragmented biologics market, how single-use and continuous technologies are influencing the industry, and how integrated development strategies can help reduce scale-up risk. Bass also discussed the growing role of AI and machine learning in process development and what could drive broader adoption of advanced biomanufacturing technologies.

The Trump administration’s plan to impose 100% tariffs on imported generic drugs by August 2028 is spurring conversations about whether manufacturers can realistically reshore production before that deadline. But bringing production back to the U.S. will require more than tariffs alone, as manufacturers consider challenges around cost, capacity, workforce and infrastructure. In this episode of Off Script, we spoke with Tom Strohl, president of Oliver Wight Americas , about the critical factors manufacturers need to consider to make pharmaceutical reshoring a reality. Strohl discussed the importance of considering the total landed cost of domestic versus overseas production, the capacity and workforce challenges associated with large-scale reshoring, and why moving API production back to the U.S. could prove even more difficult than finished-dose manufacturing. We also discussed if manufacturers have enough time to prepare for the 2028 tariff cliff, how manufacturers can balance cost with the long-term benefits of a more resilient domestic supply chain, and how AI and robotics could support a new generation of domestic manufacturing.

Researchers have developed a new sensor-enabled bioreactor that uses machine learning technology for improved enzyme production. This advanced technology—created by researchers at Iowa State University and Novonesis , with funding by BioMADE —pairs continuous monitoring with AI-guided control to give manufacturers a faster, more precise way to manage enzyme production. In this episode of Off Script, we connected with Mike Hess, senior regional technology manager at Novonesis, and David Nathan, program director at BioMADE, to discuss the development of the new bioreactor and how real-time monitoring and AI-based control help manufacturers automate previously manual processes, improve batch consistency, and ultimately accelerate the path to market. The conversation also explored how the project led to the development of low-cost bioreactors that researchers are now working to turn into hands-on bioprocessing educational kits for students.

Sterile ophthalmic manufacturing is facing growing demand as more preservative-free therapies move through development, while manufacturers also contend with increasingly stringent expectations around contamination control, inspection, and quality. Blow-fill-seal (BFS) technology offers a closed, highly automated approach that can reduce contamination risks while producing billions of unit doses at scale. In this episode of Off Script, we spoke with Jody Chastain, CEO of The Ritedose Corporation , about the role of BFS in the future of sterile ophthalmic manufacturing. Chastain discussed how automation is improving manufacturing speed and container integrity, why packaging decisions are increasingly being made earlier in development, and how manufacturers are adapting to evolving FDA expectations and Annex 1 principles. He also explored manufacturing redundancy, AI-enabled quality operations, automated inspection, and the future of BFS technology.

Radiopharmaceuticals are a rapidly growing area of oncology, fueled by advances in targeted therapies and expanding product pipelines. But bringing these therapies from development to commercialization presents unique manufacturing challenges, from isotope supply and specialized GMP facilities to the “just-in-time” distribution models required by the short half-lives of these radioactive medicines. In this episode of Off Script, we spoke with Thijs Spoor, CEO of Perspective Therapeutics , about the current state of radiopharmaceutical manufacturing and what the industry needs to support the next phase of growth. Spoor discussed why manufacturing capacity has become one of the industry's biggest bottlenecks, how companies are approaching facility expansion and supply chain resilience, and why distributed manufacturing networks are integral. He also touched on workforce challenges, evolving regulatory expectations, and continued investment that is supporting the industry's growth.

The demands on pharmaceutical manufacturing quality teams are growing as they manage larger volumes of data driven by increasingly complex therapies and evolving regulatory expectations. In response, artificial intelligence is emerging as a powerful tool to help quality professionals synthesize information more efficiently, improve consistency across investigations, and support more informed decision-making. In this episode of Off Script, we spoke with Charlie Lickfold, Chief Technology Officer at Catalent , about how the company is deploying AI to modernize pharmaceutical quality management. Lickfold explains why advanced modalities like cell and gene therapies are driving demand for AI-enabled quality systems, how Catalent’s new QAI platform is assisting in quality management, and why human oversight remains essential in regulated quality operations. He also discusses evolving regulatory expectations, AI governance, and organizational strategies that can support successful enterprise AI deployment.

Single-use technologies have reshaped biopharma manufacturing facility design, capacity strategy, and flexibility over the past decade. The industry has expanded with a growing range of targeted therapies and emerging modalities, which has led to manufacturers adopting single-use systems to meet demand. The shift has enabled more flexible facilities, faster product changeovers, and manufacturing strategies better suited to scaling next-generation biologics. In this episode of Off Script, we spoke with Charlie Heise, associate director of Bioprocess Strategy and Development at Fujifilm Biotechnologies , about how single-use technologies have transformed facility design over the past decade and where things are headed. Heise discusses the industry's shift from process-specific plants to flexible manufacturing platforms, the growing role of single-use systems in continuous manufacturing and process intensification, and why standardization and digital integration are essential. He also explores how hybrid manufacturing models, regional production, and evolving therapeutic modalities will shape the next generation of biopharma manufacturing.

Biopharmaceutical manufacturing processes are becoming more complex, prompting manufacturers to evaluate filtration based on its impact across the entire process rather than as a standalone unit operation. Filtration decisions can influence everything from system footprint and flow performance to integration complexity, product recovery, and overall operational efficiency. Growing emphasis on sustainability and yield is also leading manufacturers to examine hidden inefficiencies. In this episode of Off Script, sponsored by Saint-Gobain Critical Process Solutions , we spoke with Hannah Hertrick, market development manager of Filtration Products at Saint-Gobain, about how filtration is evolving into a system-level optimization opportunity. The conversation explores why filtration decisions increasingly extend beyond membrane performance, how filter design and connectivity can simplify system integration, and why manufacturers are taking a more holistic approach to improving process efficiency. Hertrick also discusses the challenge of holdup volume in high-value biologics, the impact of hidden product losses on yield and cost of goods, and the overall importance of reducing system complexity and improving product recovery.

A unique team of specialists in data generation and artificial intelligence are co-developing an AI genomic model capable of predicting genomic edits that improve commercial-scale protein production. This collaboration between Triplebar and UC Berkeley —with funding from the U.S. Department of Defense and the National Science Foundation through a BioMADE grant—aims to accelerate strain optimization for more resilient, cost-effective protein manufacturing across therapeutic and industrial applications. In this episode of Off Script, we spoke with Shawn Manchester, CEO of Triplebar, about how the company's ultra-high-throughput microfluidics platform is being paired with UC Berkeley's genomic language model to transform strain engineering. Manchester discussed the motivation behind the collaboration, explained how this genomic language model differs from traditional AI approaches, and explored how they could improve protein expression, shorten development timelines, and reduce manufacturing costs. He also shared his vision for how AI-driven strain optimization could help enable the next generation of protein therapeutics and other biomanufactured products.

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.

As municipal water utilities increasingly shift from free chlorine to chloramine disinfection strategies, pharmaceutical manufacturers are facing new challenges in maintaining consistent, high-purity water systems. While chloramines provide utilities with longer-lasting residual disinfection and reduced formation of regulated byproducts, they also introduce operational risks inside pharmaceutical facilities. As a result, manufacturers are reassessing traditional chloramine removal approaches and exploring more proactive treatment strategies that improve resiliency, monitoring, and long-term operational efficiency. In this episode of Off Script, sponsored by Trojan Technologies , we spoke with Wayne Lem, global applications manager at Trojan Technologies, about the evolving role of UV technology in pharmaceutical water treatment systems. The conversation explores how chloramine shifts at the municipal level are impacting pharmaceutical manufacturing operations, the limitations of traditional approaches like catalytic carbon and reducing chemicals, and how UV-based chloramine destruction can help facilities improve process reliability while reducing maintenance and chemical dependency. Lem also discusses the operational and economic considerations behind UV adoption, the importance of continuous monitoring and validation in regulated environments, and why hybrid, multi-barrier treatment strategies are becoming increasingly important as manufacturers modernize water infrastructure.