Episode 64: Compliance in the Biotech Industry | Paul Michel

Paul Michel, Senior Consultant at Skillpad, recently featured on Episode 64 of the Automating Quality podcast, produced by SOLABS.

Titled “Compliance in the Biotech Industry with Paul Michel”, the episode explores the realities of GxP compliance in modern biopharma manufacturing.

With over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing, Paul specialises in GMP training, compliance readiness, and supporting organisations through the complexities of product development and commercial manufacturing.

In this 20 minute discussion, the conversation focuses on the evolving compliance landscape within biotech and biologics.

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 digitalisation are critical to closing the CDMO capacity gap

Thank you to SOLABS for producing this episode of the Automating Quality podcast. The series includes 63 additional episodes covering automation and quality in the life sciences sector.