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, EP and USP, we are ensuring compliance for mycoplasma screening of cell lines and biological products for our global customers,” said Dr. Jeri Ann Boose, Lancaster Laboratories’ director of biopharmaceutical services.

The mycoplasma testing program features include: traceable, characterized and qualified positive control strains; formalized analyst training program; limited access pressure-controlled labs, HEPA-filtered, and operate on independent air handling systems; separate labs for testing of client test articles and handling of positive control strains; mycoplasmastasis testing to qualify each assay for each test article; support for mycoplasma clearance studies; and access to the company’s LabAccess system, allowing 24/7 easy access to study information, reports and study data.


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