But......
Every time I lean on the F word, I end up remembering what FDA was like, when I entered pharma/biotech. The only two platforms where they were known to be ultra-careful, perhaps to a fault? Cell lines used in the production of viral vaccines and adjuvants used for same.
My task was to convince FDA that we (Bayer) should be allowed to produce human monoclonals from EBV transformed cell lines. I walked into Bethesda meetings, not knowing that PCR had been invented down the road from us at Cetus. FDA scientists were fascinated with our yields in both hollow fiber and stirred tanks, and were well aware of what PCR meant to the future of quality control for proteins produced from cell culture. They did everything they could to get us together, but Cetus was our fierce competitor. We ended up exchanging info re. specificity, yield, etc., but I got nada re. production and Q.A. It was at least a year after my first presentation in Bethesda before I learned of PCR.
Picture me, walking in for major presentations re. a project of significant interest to FDA. We (Bayer/Genetic Systems) were the clear leader in human monoclonals, and there I was, talking about Q.A. standards which FDA knew would soon seem primitive. |
