Sterility and Mycoplasma Throughout the development process, raw materials, cell banks, and bulk and final drug products need to be tested for the absence of microbial, fungal and mollicute (Mycoplasma and Spiroplasma) contaminants. This testing is also essential for the release of final products to the market. Charles River can partner with you in all phases of drug development to help ensure that your materials are contaminant-free. The methods developed at Charles River comply with different compendial guidelines outlined by multiple global regulatory authorities. If a product is being released into multiple regulatory environments, single methods have been developed to satisfy more than one guideline in order to decrease costs and material consumption. Product-specific method development and consultation is also available. Bacteria & Fungi Mycoplasma & Spiroplasma Charles River offers multiple microbial detection methods based on the type of material being tested, including: Sterility Testing - isolator environment available Direct inoculation Membrane filtration Bacteriostasis and Fungistasis (B&F) Testing Bioburden Testing Microbial Limits Testing The size and structure of Mycoplasma and Spiroplasma allow them to pass through filters and go unnoticed. The technical experts at Charles River are skilled in the detection and identification of mollicutes using the following techniques: Quantitative Fluorescence PCR (QF-PCR), including protocols with broth enrichment steps Individual protocols meeting PTC, EP, JP or USP requirements EP/USP harmonized protocol EP/USP/JP harmonized protocol Mycoplasma detection by the large volume method Mycoplasmastasis Spiroplasma QF-PCR, for products that have been in contact with plant or insect materials Mycoplasma clearance studies You may also be interested in... Release Testing Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets. Regulatory Document Library Access regulatory documents from the FDA, EMA, MHLW, WHO and more. Viral and TSE Clearance Studies Expertise in the design and execution of studies for multiple products and materials. Cell Line Characterization Services Design and execution of a complete testing program for your cell line that is customized to meet your exact specifications and is compliant with international regulatory guidelines.
Charles River offers multiple microbial detection methods based on the type of material being tested, including: Sterility Testing - isolator environment available Direct inoculation Membrane filtration Bacteriostasis and Fungistasis (B&F) Testing Bioburden Testing Microbial Limits Testing
The size and structure of Mycoplasma and Spiroplasma allow them to pass through filters and go unnoticed. The technical experts at Charles River are skilled in the detection and identification of mollicutes using the following techniques: Quantitative Fluorescence PCR (QF-PCR), including protocols with broth enrichment steps Individual protocols meeting PTC, EP, JP or USP requirements EP/USP harmonized protocol EP/USP/JP harmonized protocol Mycoplasma detection by the large volume method Mycoplasmastasis Spiroplasma QF-PCR, for products that have been in contact with plant or insect materials Mycoplasma clearance studies
Release Testing Release testing services for bulk drug substances and clinical and marketed products for the European Union (EU), United States (US) and other regulatory-distinct markets.
Viral and TSE Clearance Studies Expertise in the design and execution of studies for multiple products and materials.
Cell Line Characterization Services Design and execution of a complete testing program for your cell line that is customized to meet your exact specifications and is compliant with international regulatory guidelines.