Friday, May 5, 2023 Daily Archives

Rapid Discovery and Characterization of Monoclonal Antibodies Against the SARS-CoV-2 Delta Spike Protein

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The COVID-19 pandemic has led to a rapid and wide-ranging search for therapeutics to protect against and treat the illness. Besides the vaccines and antivirals that have been developed against SARS-CoV-2, a number of mAbs have been given emergency use authorization (EUA) by the FDA. Unfortunately, the neutralizing effect of mAb therapeutics can be reduced or negated by the evolution of viral variants. For this reason, the expedited discovery and development of new mAbs with neutralizing activity selective for novel…

May 5, 2023

FDA hits both Lilly and Rentschler with 483s

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Aseptic manufacturing concerns have landed Eli Lilly and Rentschler separate Form 483s at facilities that have previously fallen foul of the US FDA. The US Food and Drug Administration (FDA) inspection of the 1555 South Harding Street, Indiana, Indianapolis facility in October 2022 resulted in Eli Lilly receiving a Form 483 with three observations. The document cites Lilly’s aseptic technique for drug product filling operation as “deficient,” with concerns surrounding unprotected sterile surfaces and the actions of operators at the…

May 5, 2023