Off Script: A Pharma Manufacturing Podcast

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.