Dedicated equipment, minimal operator intervention, and single-use technologies are just a few keys to success in the aseptic processing of biopharmaceuticals.
By Bruce Flickinger
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Although biological products and their potential contaminants are fickle entities, the manufacture of sterile biopharmaceuticals has matured into a well-characterized, industrialized endeavor. Much of the uncertainty is gone, the constraints and opportunities are largely understood, and incidents of compromised products reaching consumers are relatively rare. These facts speak volumes about the technologies, training, processes, and ongoing research involved in bringing aseptically processed drug products to market