Monday, February 13, 2023 Daily Archives

For CGT training, the future’s made of virtual reality

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Students in Birmingham, UK are being trained in the production and administration of cell and gene therapies (CGTs) using virtual reality software. BioProcess Insider spoke with Professor Ivan Wall, co-founder and CEO of FourPlus Immersive, to find out more. Wall’s company produces virtual reality (VR) software that students and biopharmaceutical industry professionals use to train in good manufacturing practices (GMPs), which recreates the hands-on experience of cleanroom manufacturing. Apprentices train at the National Training Centre for Advanced Therapies Manufacturing at…

February 13, 2023

US FDA again delays Biocon bevacizumab approval on back of 483s

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The Complete Response Letter (CRL) outlines the need for Biocon Biologics to resolve observations made during facility inspections in August 2022. Biocon confirmed the US Food and Drug Administration (FDA) has issued a CRL for the Biologics License Application (BLA) for a biosimilar version of Roche’s Avastin (bevacizumab) filed by Viatris (formerly known as Mylan). Biocon   acquired the biosimilars division from its partner Viatris in February 2022 in a deal worth $3.3 billion. “The US FDA has issued a CRL…

February 13, 2023

Roche building commercial plant as part of $700m CA spend

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Following the inauguration of a Clinical Supply Center in South San Francisco, Roche’s Genentech has begun construction of a small-batch commercial plant at its Oceanside site. Acquired from Biogen Idec by Genentech (later part of the Roche Group) in 2004, the Oceanside, California site boasts seven buildings with 575,000 square feet of manufacturing capacity spread across 60 acres. Now the firm has broken ground on another facility, which will produce small-batch commercial biologics. According to the firm, the plant will…

February 13, 2023

AGC and Genenta expand manufacturing agreement

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AGC Biologics has entered into a development and manufacturing services agreement with Genenta to produce its cell therapy lentivirus-based product. The agreement, of which financial details have not been divulged, builds on the existing relationship between hematopoietic stem progenitor cell therapy developer Genenta and contract development manufacturing organization (CDMO) AGC. Genenta already had an existing manufacturing services agreement with Molecular Medicine’s (MolMed’s) Milan, Italy facility, which AGC acquired for $284 million in August 2020. Since 2016, the site has been…

February 13, 2023