Mycoplasma testing is a critical quality control requirement in biological products, including biopharmaceuticals, vaccines and cell and gene therapy products. RSSL offers a nucleic acid amplification-based qPCR technology for mycoplasma detection, designed to meet the evolving needs of the life science industry. With quick turnarounds, we eliminate the delays that can hold up your development and manufacturing timelines .
Contact RSSL to find out how our rapid qPCR mycoplasma detection service can support your project.
Sensitive mycoplasma detection aligned with Ph.Eur. 2.6.7 and US <63>
Flexible testing for cell cultures, viral vectors, biologics, CGT products and other matrices
From cell line qualification and in-process monitoring to final product testing
Access mycoplasma confirmation alongside biosafety and product characterisation services
RSSL's mycoplasma qPCR testing delivers a rapid, highly sensitive and specific solution fully aligned with:
Our mycoplasma detection service supports testing across a wide range of biological sample types and at multiple stages of the drug product lifecycle.
We perform routine mycoplasma testing to support the qualification and on going monitoring of cell lines used in research, development and manufacturing workflows as well as final products.
Testing can be performed using any of the following approaches:
In addition to rapid real time PCR screening, RSSL offers:
RSSL is a trusted partner for global pharmaceutical and biotech leaders, with state-of-the-art laboratories featuring bioassay suites and one-directional PCR suites designed to prevent cross-contamination and deliver world-leading analytical services.
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.
Contact RSSL to find out how our rapid qPCR mycoplasma detection service can support your project.
Mycoplasma testing detects contamination by mycoplasma organisms (the smallest self-replicating bacteria) which can compromise cell cultures, alter experimental results and pose a safety risk in biological products. Regulatory authorities require mycoplasma testing at defined stages of biopharmaceutical manufacturing.
RSSL offers 48 hour and 5 day mycoplasma testing results using qPCR technology. Results are received significantly faster than traditional culture-based methods which can take 28 days.
Our qPCR mycoplasma detection method is fully aligned with European Pharmacopoeia (Ph. Eur.) Chapter 2.6.7 and United States Pharmacopeia (USP) Chapter <63> ensuring global regulatory acceptance.
Yes. Our service is highly versatile, supporting testing across cell lysates, culture supernatants, bulk drug substance, final drug product, viral vectors and other biological matrices at any stage of the product lifecycle.
