Friday, February 26, 2021 Daily Archives

Ins and outs: Changes at Moderna, ReForm Biologics, Daiichi Sankyo

Moderna has appointed executive search firm Russell Reynolds to find Tal Zaks replacement as he steps down from his position as CMO. Meanwhile, there are high level changes at ReForm Biologics and Daiichi Sankyo. Zaks has been chief medical officer (CMO) of Moderna for six years. Now with its first approved mRNA COVID-19 vaccine, Zaks will step down from his position in late September though it is unknown where he will embark on the next leg of his career. Moderna’s…

MS-Based Impurities Investigations in Biopharmaceutical Laboratories

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This webcast features: Andrew Hanneman, Scientific Advisor, Charles River Laboratories One of the major challenges to developing successful biopharmaceutical products is understanding and characterizing potential impurities. Finding the source and magnitude of these impurities allows us to minimize and remove them during the manufacturing process to create a safe and effective drug. Development also needs to include supporting stability and forced degradation studies to ensure long-term safety and efficacy. Some impurities, such as protein degradants, host cell proteins, and various…

Moderna investing $400m in mRNA capacity for COVID-19 and beyond

Moderna aims to up capacity for its COVID-19 vaccine to 1.4 billion doses through investment in ‘flexible’ manufacturing, which it says will offset any risk from variants or future overcapacity. What a year it has been for Moderna Therapeutics. For the fourth quarter 2020, the firm reported sales of $200 million – up from nothing the previous year – as regulatory approvals began rolling in for its messenger RNA (mRNA) COVID-19 vaccine mRNA-1273. Since it began working on a COVID-19…

CDMO quadruples lentiviral capacity on the back of cell gene demand

VIVEbiotech has responded to the high demand for lentiviral vectors in the cell and gene therapy space by expanding its facilities. While no financial details have been disclosed, the Spanish contract development manufacturing organization (CDMO) said it is ramping up its manufacturing capacity and processes enabling it to respond to lentiviral demand. “We are based in San Sebastian in northern Spain, very close to the French border,” a spokesperson told BioProcess Insider. “Our facilities will be increased in around 3,000…

COVID-19 MAbs should be made with combination in mind says US FDA

Monoclonal antibody (mAb) manufacturers aiming for an EUA should prepare for their SARS-CoV-2 therapies to be combined with others, according to the US FDA. The US regulator issued the advice in guidance this week in which it also urged developers to collaborate and share data. The FDA said, “Strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the…