Episode 64: Compliance in the Biotech Industry with Paul Michel

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management.

In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing.

Together, they explore the realities of GxP compliance in biopharma manufacturing — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.

Key Takeaways

02:11 Why biologics manufacturing is fundamentally more complex than small molecule production

04:10 How living cell systems introduce variability and demand tight process control

05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone

10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance

13:06 The growing demand for advanced quality skills in biologics and digital environments

17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches

20:47 Why automation and digitalization are critical to closing the CDMO capacity gap

Contact Paul Michel on LinkedIn here: Paul Michel (He/Him) | LinkedIn

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