Tuesday, March 2, 2021 Daily Archives

Catalent dismisses production problems in J&J COVID vaccine rollout

CDMO Catalent has refuted claims that US rollout of the recently approved J&J vaccine has been slowed down by problems at its fill-finish facilities. Shortly after the US Food and Drug Administration (FDA) approved Johnson & Johnson’s single-shot  vaccine making it the third authorized COVID vaccine  in the US, the Financial Times reported that Catalent is suffering production problems that “have contributed to the US government being set to receive millions fewer doses than it expected this month.†The British…

MilliporeSigma to manufacture biologics for Alteogen

South Korean firm Alteogen has partnered with CDMO MilliporeSigma to develop and produce biotherapeutics and monoclonal antibody drugs. The collaboration will see MilliporeSigma (the life sciences business of Germany’s Merck KGaA) provide Alteogen with late-stage manufacturing services which includes developing and producing recombinant biologics for clinical evaluation. “This agreement supports large-volume subcutaneous administration of biologics that would otherwise be administered as an IV infusion,†said head of Process Solutions at Merck, Andrew Bulpin. “This advances Merck’s strategy of providing breakthrough,…

Avid kicks off second phase of $60-70m capacity expansion

After beginning a $15 million expansion of its Myford, California facility late last year, CDMO Avid Bioservices is starting work on a second extension estimated to cost $45 to $55 million. Contract development and manufacturing organization (CDMO) Avid Bioservices had been looking to build out the Myford, Tustin, California production facility for several years to prepare for continued high demand from the biologics sector. Plans for a $30-40 million expansion finally materialized last July, but no date or details were…

Eurofins on how to get faster sterility results

Due to the 14-day incubation requirement for compendial sterility, this is often the last data available when testing BioPharmaceutical products for release or stability. So turnaround time pressure has always been an inherent part of sterility testing. This pressure has become more acute with the emergence of ATMPs, particularly autologous cell therapies which are often given to patients before traditional testing results can be obtained. Eurofins BioPharma Product Testing has responded to the demand for faster sterility results by streamlining…