19-Nov-2010

Lancaster Laboratories launches mycoplasma USP <63> assay

Biological safety testing company Lancaster Laboratories, part of Thermo Fisher Scientific, has introduced a cGMP compliant mycoplasma assay, harmonising both United States Pharmacopeia (USP) Chapter <63> monograph and European Pharmacopoeia Chapter 2.6.7 guidelines.

With effect from 1 October 2010, biopharmaceutical companies performing mycoplasma testing need to comply with the USP’s recently published Chapter <63> Mycoplasma Tests. Chapter <63> was intended to bring requirements in the US closer to those outlined in the EP and to further harmonise 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 cause 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.

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 programme include:

  • Fully traceable, characterized and qualified positive control strains
  • Formalised analyst training programme, including required proficiency assessments using blind samples
  • Limited access laboratories that are pressure-controlled, HEPA-filtered, and operate on independent air handling systems to prevent cross contamination
  • Separate laboratories for testing of client test articles and handling of positive control strains, including a unidirectional workflow that ensures handling of test articles prior to manipulating positive controls on each working day
  • Assays performed in strict compliance with cGMPs
  • Mycoplasmastasis testing to qualify each assay for each test article
  • Support for mycoplasma clearance studies, including consultation and study design
  • Access to Lancaster Labs’ proprietary LabAccess system, allowing 24/7 easy access to study information, final reports and actual raw study data

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