Articles with "manufacturing regulatory" as a keyword



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Enabling development, manufacturing, and regulatory approval of biotherapeutics through advances in mass spectrometry.

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Published in 2021 at "Current opinion in biotechnology"

DOI: 10.1016/j.copbio.2021.08.001

Abstract: Rapid technological advances have significantly improved the capability, versatility, and robustness of mass spectrometers which has led to them playing a central role in the development, characterization, and regulatory filings of biopharmaceuticals. Their application spans… read more here.

Keywords: enabling development; product; manufacturing regulatory; development manufacturing ... See more keywords