Protect your Biopharmaceuticals from Mycoplasma
November 3, 2011 - Mycoplasma is one of the most common cell culture contaminants. Not only can mycoplasma contamination of cell lines affect cell growth in culture, production yields of biomolecules can be influenced as well.
Charles River Biopharmaceutical Services (BPS) offers two new harmonized protocols for mycoplasma testing. One protocol is for routine testing (GP-V611.19), while the other is for routine testing and mycoplasmastasis (GP-V611.20). Each satisfies both EP and USP regulatory requirements, allowing you to run one protocol instead of two individual assays.
- Customizable – Both protocols provide optional controls and cell substrates, allowing for customization based on the material type being tested.
- No increase in cost – Testing is offered at no additional cost over our previous non-harmonized individual methodologies.
- No additional materials required – Send the same amount of material as you would for a single compendial methodology.
BPS provides microbiology support for lot release programs, manufacturing and stability testing. Testing can be carried out according to the Japanese Pharmacopoeia (JP), the FDA Points to Consider (PTC), the European Pharmacopoeia (EP), or the United States Pharmacopeia (USP).
For additional information about these harmonized protocols, please contact us at askcharlesriver@crl.com.
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