Mycoplasma Tests
Mycoplasma contamination presents significant challenges for research laboratories and commercial facilities developing and manufacturing cell-derived biological and biopharmaceutical products for therapeutic use. Undetected mycoplasma in these products can pose safety risks to patients and business risks to manufacturers. Mycoplasma testing can help address these concerns and develop a mycoplasma-free environment. Our services include the industry standard USP/EP/JP compliant culture methods, as well as automated real-time PCR assays. These methods are optimized for a wide range of test articles that may have challenges such as short shelf-lives or limited volumes.
Our PCR assays are designed to match or exceed the detection limits of traditional culture methods and can distinguish between viable and non-viable mycoplasma contaminants, offering a reliable alternative to the traditional testing approach.
USP/EP/JP/PTC Compliant Mycoplasma Assays
Mycoplasma safety is critical for biologics and vaccines produced for clinical studies and licensed products for human use. Submissions of Investigational New Drug (IND) and Biological License Application (BLA) must include sampling and testing plans for raw materials, in-process samples and the final product to confirm the safety of the manufacturing process and the absence of mycoplasma contaminants in the final product. Fully harmonized compendial (culture) and rapid (PCR) methods that meet or exceed USP<63>, EP2.6.7 and JP XVII G3 requirements are available
The culture method involves inoculating samples into both liquid and solid media, followed by incubation under specific growth conditions to promote the growth of any free mycoplasmas.
The indicator cell culture method is designed to detect cell-associated mycoplasmas. This method involves inoculating samples onto a monolayer of indicator cells that support growth of cell-associated mycoplasma species.
The mycoplasmastasis assay is essential to ensure that test samples do not interfere with the detection of mycoplasmas using both the culture method and the indicator cell culture method. This assay confirms the absence or presence of inhibitory substances in the test sample that could potentially suppress the growth of mycoplasmas.
The Enrichment MycoSEQ RT-PCR assay combines an initial enrichment step using both the culture method and the indicator cell culture method with subsequent MycoSEQ Plus RT-PCR amplification for detection of viable mycoplasma contaminants. This assay provides several advantages over compendial culture methods and PCR methods including improved specificity and robustness, increased sensitivity, and reduced sample volume.
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Thank you for your interest in our mycoplasma testing services. Whether you need routine testing, method development or validation, our team is here to assist you.