Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

Applied Biosystems™ MycoSEQ™ Mycoplasma Detection Kit

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

Features

• PCR Method: qPCR
• Detection Method: SYBR

Contents

• This kit contains Power SYBR Green mix, assay mix, and discriminatory positive control/inhibition control