By Louis Garguilo, Chief Editor, Outsourced Pharma
A representative for U.S.-based CDMOs recently testified before Congress regarding the fact 80% of our API is manufactured overseas. If you ask me, they picked the right guy to hear from. “The irony is the same biopharma companies that come to me for clinical material don’t want to go to India and China because of quality issues, but then their API gets manufactured there anyways,” said Edward Price, President & CEO, SEQENS N.A.
The EMA recently issued two new publications containing information on nitrosamines for marketing authorization holders (MAHs). Every MAH and manufacturer of chemically synthesized APIs and resulting drug products should carefully read the new EMA expectations on potential nitrosamine contamination.
During the past decade there have been innumerable and contentious comparisons between stainless-steel and single-use (SU) biomanufacturing systems. The reality is that stainless steel and SU can coexist — and often do — in today’s hybrid bioprocessing manufacturing environments.