Decides to amend Paragraph 121 of the Operational Guidelines with the addition of the highlighted bold text as follows: The Upstream Process advice provided regarding a site will not prejudge the ...

Modern upstream bioprocessing relies on tighter control strategies as regulators and manufacturers push toward real-time decision making. Yet the inherent variability of living cell systems makes it ...

Cell and gene therapies offer hope for previously untreatable diseases, with viral vectors currently favored as the primary gene delivery method. To meet patient needs, reliable and cost-effective ...

Polyethylenimine (PEI)-assisted transfection is a mainstay in upstream processing (USP) for viral vector manufacturing. But recent developments are shifting it from a ...