LANCASTER, Pa., November 17, 2010—Lancaster Laboratories, a global leader in biological safety testing, has introduced a new cGMP compliant mycoplasma assay, harmonizing both United States Pharmacopeia (USP) Chapter <63> monograph and European Pharmacopoeia Chapter 2.6.7 guidelines.
With the USP’s recently published Chapter <63> Mycoplasma Tests, biopharmaceutical companies performing mycoplasma testing need to comply with this new guideline, effective October 1, 2010. Chapter <63> was intended to bring requirements in the U.S. closer to those outlined in the EP and to further harmonize mycoplasma testing by bringing greater alignment in the monographs.
Mycoplasma contamination of cell culture represents a significant issue in the development and production of biologics. Mycoplasma contamination events can lead to altered physiological properties of cells, leading to reduced or altered cellular products and perhaps unsafe biopharmaceuticals. Thus, testing for the presence of mycoplasma contamination in development and manufacturing is a requirement by the worldwide regulatory agencies, including the United States, Europe and Japan. Guidance for this testing is provided in the FDA 1993 Points to Consider (PTC), European Pharmacopoeia Chapter 2.6.7 Mycoplasmas, and the Japanese Pharmacopeia XV,14. 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.” says Dr. Jeri Ann Boose, Lancaster Laboratories’ director of biopharmaceutical services.
Features of Lancaster Laboratories Mycoplasma testing program include:
Founded in 1961, Lancaster Laboratories is the global leader in pharmaceutical and biopharmaceutical laboratory services, providing innovative and timely scientific solutions that enable customers to better manage the drug development process. Visit lancasterlabspharm.com and discover why customers rank Lancaster Laboratories #1.