Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly. This Points-to-Consider document provides a summary of microbiological challenges for ATMPs and guidance on how to address these challenges based on the current state of technology, regulatory environment, and industry best practices. The PtC addresses ATMP process technologies from cell-free production of mRNA therapeutics to viral vector-induced in-vivo gene therapies to ex-vivo engineering of human cells for autologous or allogeneic cell therapies. The control aspects covered include facility design, equipment and instrumentation design and maintenance, analyst and operator gowning and qualification, and microbiological process monitoring.

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Table of Contents:

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Introduction

1. Planning and Notification of a Remote Inspection
2. General Considerations
3. Topic 1: Incoming Apheresis/Leukapheresis Material
4. Topic 2: ATMP Stability Studies
5. Topic 3: Materials Used to Manufacture ATMPs
6. Topic 4: General Requirements for Microbiological Samples for ATMP Testing
7. Topic 5: Aseptic Processing Aimulations
8. Topic 6: Bioburden and Sterility Testing
9. Topic 6.1: Bioburden Testing
10. Topic 6.2: Sterility Testing
11. Topic 6.3: Rapid Sterility Test Methods
12. Topic 7: Endotoxin Testing
13. Topic 8: Mycoplasma Testing
14. Topic 9: Adventitious Virus Safety
15. References

Figures and Tables Index