As per the presentation, Q7A isn’t intended to raise the GMP expectations for classical fermentation. It was mentioned that cell culture fermentation was one of the two differences between Q7A and the FDA’s previous draft guidance. Confirm or clarify that the main difference is the moving of the line from isolation/purification back to the introduction of cells into the fermentation.

The distinction made in the presentation was that FDA’s March 1998 draft industry guide for
manufacturing, processing and holding APIs was essentially biased toward chemical synthesis
activities or operations. It did not provide guidance for APIs produced by biotech or fermentation.
It has always been the expectation that APIs produced by biotech or fermentation be
manufactured under cGMPs. So this is not a new expectation. The difference is that these APIs
were not specifically addressed in the FDA 1998 draft guide.