The MycoSEQ Mycoplasma Detection Kit is a real-time PCR assay designed and validated to meet the requirements of European Pharmacopeia Chapter 2.6.7. The primers were designed using a proprietary bioinformatics pipeline to detect >90 mycoplasma species with high specificity and no cross-reactivity to closely-related bacterial species. The assay's sensitivity has been demonstrated by internal and external validations to detect 10 cfu/mL or the genomic equivalent of 10 GC/mL as recommended by regulatory guidance.
Real-time PCR provides rapid results, making this assay ideal for in-process testing or part of a microbial risk mitigation strategy across a bioprocess workflow, including cell line characterization, raw material tests, etc. Additionally, it allows for rapid lot release testing across multiple biotherapeutic modalities (e.g., biologics, vaccines, cell therapy products) and has been widely used and accepted by regulatory authorities following the required validation.
The PrepSEQ nucleic acid extraction module included with this version of the kit offers a robust and easy workflow to overcome complex matrix challenges to ensure the required sensitivity. Unlike other mycoplasma kits available, the MycoSEQ kit also includes a proprietary Discriminatory Positive Control to differentiate a true positive from any potential cross-contamination positives. This is a key feature in avoiding false positive results from mycoplasma controls used during validation or routine testing.
To date, there are more than ten global manufacturers of therapies subject to U.S. Food and Drug Administration, European Medicines Agency, and/or local regulatory agency review that have received regulatory acceptance for accelerated lot release protocols that specify the Thermo Fisher Scientific MycoSEQ method.