The US Food and Drug Administration (FDA) has issued draft guidance to assist manufacturers in complying with its good manufacturing practice (GMP) regulations under 21 CFR 211.110 governing batch ...
Learn how viral vector release testing for AAV and lentiviral vectors utilizes orthogonal assays for titer, capsid content, ...
Automated quality control using rapid PCR assays is replacing 28-day culture tests, cutting biopharmaceutical lot release ...
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