Mycoplasma testing is a critical quality control requirement in the pharmaceutical and biotechnology industries. It ensures that biological products, such as biopharmaceuticals, vaccines and cell and gene therapy products are free from mycoplasma contamination.
At RSSL, we understand that timely and reliable Mycoplasma detection is essential to maintaining regulatory compliance and keeping your projects on schedule. Our rapid Mycoplasma real-time PCR test provides a highly sensitive, specific and compliant solution aligned with European Pharmacopoeia (Ph. Eur) Chapter 2.6.7 Mycoplasma and United States Pharmacopeia (USP) Chapter <63>.
RSSL has launched nucleic acid amplification (NAT) based PCR (qPCR) technology to enable mycoplasma testing, meeting the evolving needs of the life science industry. This service offering provides the following key advantages:
High Sensitivity and Specificity
Detection of trace levels of Mollicute DNA (Mycoplasma, Acholeplasma, Spiroplasma) with high specificity.
Rapid turnaround
Rapid results, crucial for timely decision-making and faster batch release.
Broad Detection Spectrum
Detection of multiple mycoplasma species in a single qPCR assay.
Culture Independent:
Analysis can be completed directly on material and negates the time-consuming requirement of the mycoplasma culture dependent methods.
Versatility:
Suitable for various matrices, during different stages of biopharmaceutical production from cell banks to final products.
Cost-Effective
Rapid detection reduces downtime and resource requirements.
Regulatory Compliance
Validated in accordance with European Pharmacopoeia (Ph. Eur.) General Chapter 2.6.7, demonstrating sensitivity to ≤10 CFU/ml. In the event of a qPCR positive mycoplasma test, RSSL offers dedicated confirmatory procedures in accordance with the EP and USP Mycoplasma standards.
In addition to rapid real time PCR screening, RSSL offers:
With extensive experience in compendial monographs, Pharmacopeial testing including USP and EP, GMP testing along with many years experience handling biological material, RSSL is uniquely positioned to support your biosafety, release and validation testing needs.
Our scientists combine deep technical expertise with a client-focused approach ensuring every test supports your regulatory, quality, and commercial objectives.
