Regulatory Open Forum

We’re curious about this group’s thoughts on a few of the topics that’ll be covered next month during the Biologics CMC: Phase Appropriate Product Development online workshop on 8-9 May. 

We’d love to hear from any RA or QA folks or managers or scientists who are currently working in biopharmaceutical CMC development and preparation. 

What are your top challenges in your upstream process (preparation of media, fermentation, harvesting/recovery, critical process parameters, PAT) and how do they differ from your downstream issues? 

Also, if you have any advice on what analytical methods you’re finding successful that would be helpful to hear too.  

Thanks for sharing your expertise and experiences.