01.30.21 -- Is Your Definition Of Quality Culture The Same As The FDA's?

Steven Niedelman and Christina Markus boast more than 70 collective years of pharmaceutical regulatory experience, which will be on full display when they tell you where your quality culture may be falling short at the upcoming FDA/Xavier PharmaLink conference in March. Here’s a sneak peek.

Recent improvements in our understanding of the human genome, together with advanced DNA editing and analytical tools, position the cell and gene therapy market for explosive growth. However, these technologies have significant formulation development, cGMP manufacturing and aseptic filling challenges. The engagement of a CDMO partner with a broad portfolio of delivery technologies, a strong formulation track record and manufacturing flexibility is the preferred pathway for success.

FDA warning letters due to incomplete data in the pharma and biotech industries can be prevented by ensuring the reliability of electronic records, a process known as Compliance with Data Integrity. 

This paper explores one approach for overcoming several scale-up issues with the use miniature bioreactors for process development.

This eBook describes automation of continued process verification and offers a one-click solution for statistical trending of data, campaign reports, and annual product quality review.