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Lancaster Laboratories has introduced a new cGMP compliant mycoplasma assay, harmonizing both United States Pharmacopeia (USP) Chapter monograph and European Pharmacopoeia Chapter 2.6.7 guidelines.
November 22, 2010
By: Tim Wright
Editor-in-Chief, Contract Pharma
Lancaster Laboratories has introduced a new cGMP compliant mycoplasma assay, harmonizing both United States Pharmacopeia (USP) Chapter monograph and European Pharmacopoeia Chapter 2.6.7 guidelines. The USP’s recently published Chapter requires biopharmaceutical companies performing mycoplasma to comply with this new guideline, which is intended to further harmonize U.S. and European requirements for mycoplasma testing. “By offering validated assays performed in compliance with FDA, PTC,...
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