GMP-compliant Regulatory Mycoplasma Testing
A number of mycoplasma species are infectious agents which represent a serious health risk to humans and animals. A contamination with mycoplasma in biopharmaceutical and biotechnological manufacturing thus can compromise the safety of therapeutic medicinal products. GMP-compliant tests for confirming the absence of mycoplasma contamination in biological products being manufactured in cell cultures are therefore mandatory for the biopharmaceutical and biotechnological industries. Outsourcing these tests to Mycoplasma Biosafety guarantees that the task is carried out by experts that are knowledgeable about all details of the international regulatory standards.
Conventional Culture Methods
The international regulatory (compendial) protocols according to EP 2.6.7., USP <63>, FDA/CBER (PTC 1993/Guidance for Industry 2010), JP 17th Ed., and VICH GL34 requirements include the following two conventional culture methods for regulatory mycoplasma testing:
- The broth and agar cultivation procedure
- The indicator cell culture method applying a DNA-specific fluorochrome staining procedure
The results obtained with both procedures are only reliable in the hands of experienced operators. Mycoplasma Biosafety’s staff is well-trained to perform mycoplasma testing according to the stringent requirements of the regulatory agencies, and is well-educated on all relevant regulatory standards and latest developments. This way Mycoplasma Biosafety can ensure the best possible and reliable service for its clients. Over the years, Mycoplasma Biosafety’s experienced staff has conducted a few thousands of regulatory-compliant mycoplasma biosafety tests at various steps of the production process:
- Master cell banks
- Working cell banks
- Virus seed lots
- Control cells
- Virus harvests
- Bulk vaccines
- Final lots
- Raw materials
Rapid NAT-based Methods
Alternative rapid methods based on validated commercial PCR assays can after successful product-specific validation in compliance with EP 2.6.7. or JP 17th Ed. requirements also be implemented on customer request
- as direct PCR test
- as culture/PCR hybrid assay including an enrichment step in our mbsABO universal mycoplasma culture medium as rapid enrichment medium for all common cultivable mycoplasmas and the cell culture-adapted highly fastidious Mycoplasma hyorhinis cultivar-α strains.
We offer to our clients to design the sample preparation and PCR test layout individually as client-specific assays for their in-process control and lot-release testing needs or as "early-warning system”. Our experts have long-standing experience in validation of commercial or "home-brew" mycoplasma PCR tests and can advise you on all aspects regarding the sample preparation and testing method etc. Please contact us: email@example.com for detailed information.
Rapid Cell Culture Screening Services
In several circumstances, e.g. for research purposes, stringent regulatory GMP-compliant mycoplasma testing of cell cultures is not required. Whenever non-regulatory testing methods are requested, Mycoplasma Biosafety offers test procedures according to its in-house protocols.
These non-regulatory mycoplasma testing procedures include
- direct PCR (endpoint PCR)
- PCR including an enrichment step by cultivation
and can be applied for rapid screening of cell cultures for the presence of mycoplasmas.