Off Script: A Pharma Manufacturing Podcast

Tighter funding conditions are putting greater pressure on emerging biotech to reach key development milestones quickly while managing limited budgets. That environment is also changing what sponsors expect from their manufacturing partners, driving demand for development models that emphasize speed, predictability, and cost certainty. In this episode of Off Script, we spoke with Sanjay Konagurthu, PhD, senior director of science and innovation, Pharma Services, at Thermo Fisher Scientific, about how today's funding landscape is influencing manufacturing and development strategies. The conversation explored why emerging biotechs may benefit from fixed-scope development programs, how parallel development activities can shorten timelines without compromising quality, and how CDMOs are adapting their offerings to help sponsors move programs forward more efficiently.

Despite ongoing geopolitical and regulatory pressures, life sciences manufacturers continue to invest in their product pipelines while also being more deliberate about long-term portfolio decisions. As interest in peptides, ADCs, and cell and gene therapies continues, manufacturers are weighing the complexity and costs of developing these medicines against the need to scale production and improve patient access. Decisions about outsourcing and building in-house capabilities are also shaping investment strategies. This episode of Off Script closes out our series exploring findings from CRB’s Horizons: Life Sciences 2026 report, focusing on the section addressing pipeline expansion in a pressure-tested market. We spoke with Mark Hsu and Maddie Kelly, process engineers at CRB and co-authors of the section, to discuss what's driving investment in emerging modalities, the challenges of scaling complex therapies and making them more affordable, and how manufacturers are weighing CDMO partnerships against developing their own capabilities.

Pharmaceutical manufacturers working with hazardous and difficult-to-control chemical reactions face challenges in managing process safety, heat transfer, and reaction conditions. Flow chemistry offers an alternative to traditional batch processing in applications where improved mixing, temperature control, and smaller quantities of hazardous materials in the reactor can help reduce operational risks and improve process performance.  In this episode of Off Script, sponsored by Valsynthese, we spoke with Luca Allievi, PhD, R&D Chemist and Project Manager at Valsynthese, about the role of flow chemistry in complex pharmaceutical manufacturing. The conversation explores how flow reactors work, where continuous processing offers advantages over batch production, and how the technology is being applied to azide chemistry, gas-liquid reactions, and highly reactive reagents. Allievi also discusses the practical challenges of implementing flow chemistry and why the future of process development will depend on selecting the right technology for each reaction.

Increased regulatory scrutiny, onshoring efforts, and supply chain vulnerabilities are reshaping how life sciences manufacturers are making investment decisions across the industry. Pharma manufacturers are weighing facility locations, workforce availability, and manufacturing costs while looking for ways to strengthen supply chain resilience and improve operational efficiency. In this episode of Off Script, the third in our series exploring CRB’s Horizons: Life Sciences 2026 report, we spoke with Christa Myers, senior fellow of aseptic and sterile products at CRB and a co-author of the report. The conversation explored how manufacturers are evaluating established and emerging biopharma hubs, developing workforces to support advanced manufacturing technologies, and addressing supply chain risks. Myers also discussed how company size impacts decisions on investment and modernization, and the growing significance of process intensification to help manufacturers improve efficiency while keeping costs under control.

Life sciences manufacturers are cautiously optimistic about the potential for emerging technologies like AI, robotics and automation to improve manufacturing operations. While many manufacturers anticipate that these technologies will drive greater operational efficiencies and lower the cost of goods, concerns still remain about affordability, integration into regulated manufacturing environments — particularly for AI — and what these technologies mean for the future of the workforce. This episode of Off Script continues our series exploring findings from CRB's Horizons: Life Sciences 2026 report. We spoke with Niranjan Kulkarni, PhD, senior director of consulting services, and Matt Edwards, director of digital innovation, who co-authored a section of the report that explores the role of technology and people in life sciences manufacturing. The conversation explored why some manufacturers are expecting emerging technologies to increase costs, the challenges of implementing AI in regulated manufacturing, and how manufacturers can prepare their workforces for responsible AI adoption while maintaining human oversight.

Life science manufacturers are investing in expanded production capacity while rethinking facility design and technology strategies to improve efficiency, manage costs, and prepare for the future. Balancing upfront investments with long-term operating costs, while navigating the opportunities of automation, single-use technologies and AI, is becoming an increasingly important part of manufacturing decisions. In this episode of Off Script, we spoke with Peter Walters, fellow of advanced therapies at CRB and a co-author of the company's Horizons: Life Sciences 2026 report, about some key findings from the report. The conversation explored how manufacturers are weighing technology investments against potential cost savings and designing facilities for greater flexibility and efficiency. Walters also discussed how manufacturing strategies may differ across modalities, where AI could have the greatest impact, and why phased implementation, human oversight and careful planning remain important as companies adopt new technologies.

As biopharmaceutical manufacturers work to accelerate facility timelines while managing complex production environments, greater integration between automation, manufacturing systems and other digital technologies is becoming essential. Moving to more connected manufacturing is also driving companies to rethink how different capabilities are brought together, including a growing focus on integrating project delivery, automation, IT and manufacturing operations. This episode of Off Script explores that push toward greater integration via biomanufacturing consultancy firm Project Farma’s recent acquisition of SimoTech, a company specializing in manufacturing automation and GMP IT services for the life sciences industry. We spoke with Rich Tree, president of Project Farma, and Pat Desmond, CEO of SimoTech, about what the deal says about the industry’s broader move toward digital integration. They also more broadly discussed barriers to digital transformation, the role of standardization in accelerating projects and supporting flexible manufacturing, and how manufacturers can better connect technology investments with broader manufacturing strategies.

While artificial intelligence is expected to transform biopharmaceutical manufacturing, many manufacturers still face challenges in adopting these technologies at scale. Fragmented data, disconnected manufacturing systems and differences in how information is shared across organizations are creating barriers to AI adoption, raising questions about what manufacturers need to prioritize before investing in more advanced tools. In this episode of Off Script, we spoke with Justin Byers, founder and CEO of Axio BioPharma, about some of the findings from the company's report, AI in Biomanufacturing: The 2026–2029 Outlook. The conversation explored the gap between AI ambitions and the reality of manufacturing facilities, the importance of building a strong data foundation, and how digital twins could support more advanced biomanufacturing processes. Byers also discussed the challenges of sharing manufacturing data across industry partners, the evolving regulatory expectations around AI in GMP environments, and how AI and digital technologies could reshape biologics manufacturing in the coming years.

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.