Friday, September 14, 2018 Daily Archives

Seamless Transition from R&D to Manufacturing

Fast and cheap: These criteria are becoming ever more urgent drivers for manufacturers of biologics, faced with increased scrutiny on the costs of developing novel drugs, the lengthy timelines for delivering these drugs to patients, and the tightening competition to capitalize on new targets. The challenge for manufacturers is further heightened by the expectations to deliver on quality as well. Although development and production of molecules such as monoclonal antibodies (MAbs) have greatly benefited from the “platformization†of core technologies…

Catalent clears up FDA 483 concerns at Indiana plant

The plant in Bloomington received a Form 483 with five observations in May, but Catalent says a second US FDA inspection shows issues have been resolved. The US Food and Drug Administration (FDA) recently published a Form 483 it issued to Catalent’s biomanufacturing facility in Bloomington, Indiana following an inspection in April and May this year. The Agency made five observations at the 875,000ft2 production and fill/finish facility, which the contract development and manufacturing organization (CDMO) gained as part of…