Off Script: A Pharma Manufacturing Podcast

The Off Script podcast offers in-depth interviews and discussions with industry experts about hot-button topics in pharma, and goes behind the scenes of Pharma Manufacturing’s print and online coverage, which follows the industry’s biggest issues surrounding scale-up, technology innovations, regulations and more.

Can Pharma Manufacturers Realize AI's Potential?

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.

10-13
29:55

How Life Sciences Manufacturers are Scaling Smarter

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.

10-06
36:19

Connecting Digital Technologies Across Biomanufacturing

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.

09-29
33:18

Are Biomanufacturers Ready for AI?

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.

09-22
27:23

Adapting Biologics Manufacturing to a More Complex Market

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.

09-15
39:03

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