Manufacturing outlook on cell and Gene and aseptic processing according the EU GMP Annex 1

Title : Manufacturing outlook on cell and Gene and aseptic processing according the EU GMP Annex 1

Abstract:

The new EU GMP Annex 1 for sterile Manufacturing was published in August 2022. The industry does now have one year's time for implementation. Exception loading and unloading for the Lyophilization which provides an implementation time of two years. What does this mean for sterile Manufacturing but also for the Manufacturing of Cell and Gene Products. For Cell and Gene (ATMPs) the PIC/s published in 2021 Annex 2A for ATMPs and it might be that PIC/s link their Annex 1 with Annex 2 A which would mean higher requirements also for the manufacturing of ATMPs. The presentation will be focused on Contamination Control Strategy, Barrier Systems as those on of the major new areas to consider.  

Audience Take Away Notes:

• Comparison between EU GMP Annex 1 and PIC/s Annex 2A
• What to consider when implementation a CCS
• What is the right Barrier Solution for my process

Biography:

Richard Denk is working at the company SKAN AG, headquartered in Allschwil  in the position Senior Consultant Aseptic Processing & Containment. Richard is member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is Member of the ISO TC 198 WG-9 Aseptic Isolator Group. Richard was on the Annex 1 and PIC/s Annex 2 commenting team of the ISPE, Richard founded 12 years ago the Containment expert group of the ISPE D / A / CH. The Containment Group published the Containment Manual Richard was responsible for in September 2015. Richard has spent more than 20 years with the subject on Aseptic Processing and  highly active / highly hazardous substances and has developed the containment pyramid.