Friday, July 21, 2023 Daily Archives

Maintaining Aseptic Processes Using Small-Volume, Closed Systems

by

As targeted cell and gene therapies gain more ground in today’s healthcare landscape, small-batch aseptic processing has become integral in producing these precision medicine treatments.  This shift, coupled with downstream challenges and a widespread push to close aseptic processes earlier in upstream development, has forced manufacturers to reevaluate how to optimize sterility throughout the process.  One of the key factors in enabling closed aseptic processes is with sterile connections – maintaining the integrity of a fluid path from start to…

July 21, 2023

Tornado hits Pfizer injectable plant in NC

by

The Rocky Mount, North Carolina facility, which produces a quarter of Pfizer’s sterile injectables in the US, has been damaged by a tornado. Drug maker Pfizer confirmed its Rocky Mount plant suffered damage from a tornado, which hit the site on Wednesday. The extent of the damage caused has not been divulged, however a spokesperson for the firm confirmed the site was hit and told BioProcess Insider, “Pfizer colleagues at the site followed our established safety protocol and were able…

July 21, 2023

FDA 483 for Catalent behind CRL for Regeneron

by

The inspection at the Bloomington, Indiana site resulted in three observations and is believed to be the cause of the rejection of Regeneron’s aflibercept 8 mg last month. The US Food and Drug Administration (FDA) published the Form 483 (below) with three observations last week, following an inspection in April and May at Catalent’s Bloomington site. The Agency criticized the failure of the contract development and manufacturing organization (CDMO) to follow written and process control procedures, citing various issues with…

July 21, 2023