Bioproduction

As I was researching our Quality by Design track for this years’ BioProduction PAT was a topic that many people wanted hear more about.  

Regulatory guidelines encourage biopharm manufacturers to implement PAT to improve and advance their process developments, in order to reduce time and cost in the whole production line.  However, there are aspects of the guidelines that are still unclear to many. Industry do not know when and where to implement PAT and what technology platforms to use. 

Have you successfully implemented PAT into your production system? 

If so please share your experiences with us as I found that very few people have practical experience with this and true case study material.  

Where does PAT fit with the lifecycle initiative and Quality by Design? 

Does it sit alone or fit in the whole system? 

I look forward to hearing your thoughts on this hot topic.  

Gemma Burns