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Autor:
Marie Murphy, Stephanie Ramsey, Barbara Daddis, Christine Arbesser-Rastburg, Mousumi Paul, Sofia Asefi, David Bain, Tracy Landeryou, Anita Bawa, Bindhu Reddy, Fran Leira
Publikováno v:
PDA journal of pharmaceutical science and technology. 71(5)
The biopharmaceutical industry produces non-sterile and/or low-bioburden intermediates and bulk biologics (i.e. Drug Substances) using bioburden controlled processes in accordance to Q7A and Annex 2. In many cases, single mold isolation events have r