You mentioned that reprocessing for biotech applications might require higher scrutiny than as outlined in Section 14.2. What criteria should be considered as unique to biotech applications to allow reprocessing? Is validation required prior to lot release?

The general answer there would be yes. There have been a few reprocessing examples where
they’ve come in either as one time exceptions or they’ve come in as part of a larger reprocessing
scheme. The problem is by running a product from a biotech process back through the same
process you can have minor changes in the process that would affect the product quality, so it
may need to be validated. There’s going to be a separate CBER guidance document on
reprocessing and reworking, especially for the biotech products, and some of the other biological
products.