With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and gene therapy manufacturing can make operating companies feel like they are walking on a precarious limb. The majority of the commercial processes have taken a “one off” approach involving risk assessment and discussions with the FDA. In light of the new pipeline of products, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has developed draft guidance to help point the way. Today that draft guidance is still pointing toward risk assessing certain aspects of manufacturing to get to a new paradigm. One of those aspects is sampling and testing.
Read more on Cell & Gene: https://www.cellandgene.com/doc/sampling-and-testing-of-atmps-gaining-insights-from-pic-s-annex-2a-0001