Biopharmaceuticals, pharmaceuticals, biologics and medical devices need to be produced according to the strict requirements of Good Manufacturing Practice (GMP) and must have release testing packages carefully designed to demonstrate compliance. The Biopharmaceutical Services (BPS) group at Charles River provides microbiology support as needed for lot release programs, manufacturing, stability testing and other related situations. Testing is carried out according to the compendial methods outlined in the European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP) and the United States Pharmacopeia (USP).
Sterility Test Methods (available in isolator or clean room environments)
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Direct inoculation
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Membrane filtration
Bacteriostasis/Fungistasis
In conjunction with the sterility test, a bacteriostatsis/fungistasis (B/F) test is performed to determine whether the test article is inhibitory to the growth of microorganisms.
Monocyte Activation Test (MAT)
Charles River is committed to expanding our portfolio to offer in vitro alternatives to in vivo tests. We now offer testing using the Monocyte Activation Test (MAT) according to EP 2.6.30. The MAT works by predicting the human response to pyrogens on the basis of human fever rather than animal models. This test may be used as an alternative to the rabbit pyrogen test after a product-specific validation. MAT can test for Gram-positive and Gram-negative organisms, other biological pyrogens (e.g., yeast) as well as parasitic and viral pyrogens.
Mycoplasma/Mycoplasmastasis Testing
Charles River now offers harmonized mycoplasma protocols. There are two to choose from, each satisfying both EP and USP regulatory requirements: one for routine testing (GP-V611.19) and one for mycoplasmastasis (GP-V611.20).
Other Microbial Testing
The following microbial testing capabilities are provided:
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Endotoxin
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Bioburden
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Cytotoxicity
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Water analysis
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Identification of bacterial isolates
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Spore count verification on biological indicators
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Spiroplasma
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Mycobacterium
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Microbial limits test
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Preservative efficacy testing (PET)
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Antibiotic testing
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Disinfectant testing
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Environmental monitoring
For details on the location of services performed, please click here.
For additional information about our microbiology and sterility testing services, please contact us at askcharlesriver@crl.com.