In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Eric Doerr, a drug substance technical lead in the manufacturing science and technology (MSAT) group at Sanofi. The two discuss how the industry can support the next generation of biomanufacturing workers in North America, comparing incentives and initiatives in both the U.S. and Canada, where Doerr is based. Doerr also shares his thoughts on the need to proactively train workers in using AI to ensure that it serves as an enabling tool, rather than a disruptive force.

Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/

Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/

Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. Bozenhardt outlines his concerns with the current outsourcing environment, noting a rising rate of noncompliance driven by poor facility maintenance and a shortage of reliable workers. He offers advice to sponsor companies working with CDMOs to help ensure their assets don’t fall victim to poor partnerships and operational mismanagement.

Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/

Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/

Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance. They discuss Annex 22, the EMA’s GMP annex addressing the use of artificial intelligence (AI) in regulated manufacturing, including where it is sufficient and where it is lacking. Baker reflects on his time at the FDA and offers his own advice on AI and technology adoption and validation in GXP.

Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/

Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/

Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions