Wednesday, May 19, 2021 Daily Archives

bioCERTIFIED: Turn Your Quality Management System into a Competitive Advantage

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This webcast features: Jigisha Patel, VP of Regulatory Compliance & Technical Services, Spectrum Chemical Mfg. Corp. What can go wrong will go wrong—unless you eliminate unpredictability that results in reworks, rising costs, nonconformance, and unreliable product performance. Learn how to implement quality management systems throughout your entire supply chain and help accelerate biopharmaceutical development and production time for first-mover advantages. Whether it’s upstream or downstream processing, you will gain new insight that enables you to eliminate unpredictability and batch-to-batch variability…

Argenx confident with manufacturing supply ahead of potential efgartigimod launch

Argenx says it is ready to launch antibody fragment efgartigimod late this year despite alleged supply chain concerns stemming from its CDMO Lonza. Argenx’s lead candidate efgartigimod is a first-in-class investigational antibody fragment targeting the neonatal Fc receptor (FcRn). The candidate is being evaluated for the treatment of patients with severe autoimmune diseases and has been accepted for review by the US Food and Drug Administration (FDA) for Generalized Myasthenia Gravis (gMG). With a Prescription Drug User Fee Act (PDUFA)…

Chime’s in: Humanigen adds Chinese CDMO to support COVID mAb

Humanigen has contracted Chime Biologics to supply its potential COVID-19 therapy lenzilumab outside of the US. Lenzilumab is in late-stage trials as a treatment for ‘cytokine storm’, an overreaction of the immune system, which has occurred in those suffering from COVID-19. With planned emergency use authorization (EUA) submissions in the US by the end of May and in the UK and Europe thereafter, Humanigen has increased its manufacturing capacity through a contract with Wuhan, China-based Chime Biologics. “Globally there is…