Newsletter | November 4, 2026

11.04.26 -- Making The Jump To GMP

Demonstrating GMP Readiness And Understanding Common Pain Points

In this segment from the Bioprocess Online Live event, panelists discuss the most common challenges in scaling and transitioning a process into GMP manufacturing. They identify things such as supplier or CDMO constraints, facility fit, and technology transfers as some of the more prevalent challenges in this transition.

 

CMC Considerations Around Unique Materials And Reagents

In this segment from the Bioprocess Online Live event, the panelists advise on what to do when no GMP-grade equivalents exist for certain starting materials. When an equivalent is unavailable, development teams must determine whether the material can still be used without compromising product quality.

 

How Raw Material Decisions Can Impact Process Performance

In this segment from the Bioprocess Online Live event, panelists discuss how early-stage raw material decisions impact later-stage manufacturing and process performance, as well as the specific trade-offs to consider when it comes to raw materials for clinical manufacturing. 

 

The CDMO's Perspective: Audience Q&A With Thermo Fisher Scientific

During this final segment from the Bioprocess Online Live event, a representative and SME enters the conversation. Mike Brewer, director and global principal consultant of regulatory and bioproduction, joins the panel for a Q&A session with the audience, discussing the challenges he’s witnessed companies face in the transition to clinical manufacturing.