antihama, I should have said that Advent is not licensed for commercial production at Sawston. Advent received MHRA authorization for the manufacture of Investigational Medicinal Products (IMP). You’re correct that this requires Good Manufacturing Practice, but GMP for an investigational product are different than for a commercial product. Each clinical or investigational batch can vary widely depending on the skill of the technician or other factors, but commercial manufacturing requires far more consistency and reliability. Each stage in the commercial manufacturing process must be characterized and fully validated, which builds quality into the final product. The FDA defines process validation as, “…the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product”. Investigational products do not require process validation, and only require end-product testing. There will also be different requirements for cleaning, packaging, distribution, and documentation, etc., for a commercial product.
After Northwest Bio applies for an MAA, the MHRA will still need to conduct another inspection of Sawston to insure that Advent’s Quality Management Systems are designed to meet the challenges, and comply with the principles of Good Manufacturing Practice for a commercial product.
It seemed to me that everyone was equating Flaskworks certification with commercial production readiness, which isn’t necessarily true, and why I wrote a post a while ago about the necessity of commercial process development. If the Flaskworks system is simply certified for use in investigational medicinal products, it would be an important validation for the system, but it would later require process validation for commercial production, which doesn’t make sense to me, unless commercialization is further away than I thought.
