Why do clients choose Mycoplasma Biosafety?
Our clients benefit from our high level of scientific and regulatory experience in the management of mycoplasmas in an industrial environment.
What we offer:
- GMP-compliant mycoplasma testing according to all international regulatory guidelines
- Long-standing experience in validation of commercial or "home-brew" mycoplasma PCR tests as early-warning system or for in-process control or lot-release testing
- Excellent support from specialists and highly qualified and well-educated staff
- Consultancy services based on scientific experience in Industrial Mycoplasmology
- Individual customer care
- Strict confidentiality
- Client-specific SOPs
- Timely reporting
Individual client care is our priority. We establish individual standard operating procedures (SOPs) for each testing assay based on client-specific requirements, as well as client protocols (CPs) describing the principles of the procedures given in the corresponding SOPs. Our priority is us to adapt test procedures to the needs of our customers without unnecessary delay or compromising the compliancy with GMP or regulatory standards. This special service is much appreciated by our clients.
Furthermore, we have the necessary expertise and flexibility to adapt to our clients’ requirements. Even though mycoplasma testing needs to follow stringent regulatory protocols, special circumstances may demand special procedures, e.g. due to the nature of the test sample material. We therefore strive to offer perfect solutions for such unique circumstances.
What our clients gain:
- Avoiding the risk of mycoplasma contaminations in in-house facilities
- Saving costs for in-house facility
- Time and resources to concentrate on core business
- Obtaining services from mycoplasma experts
Where do our clients come from?
Local and global companies appreciate our services and rely on us in terms of their cell lines and products meeting the required quality and safety standards. Since 2014 Mycoplasma Biosafety has attracted over 60 clients from 19 countries and 4 continents relying on our services and products.
- Vaccine manufacturers
- Contract Manufactoring Organizations (CMOs)
- Cell therapy companies
- Detection kit manufacturers
- Contract Research Organizations (CROs)
- Academic research institutions
- Regulatory agencies
- Diagnostic laboratories
Mycoplasma Biosafety is one of the few providers worldwide specialized in detection and management of mycoplasma contamination. We can offer the required sound scientific and regulatory state-of-the-art know-how. Building on the expertise of our employees in customer-focused services and first-class quality standards we are currently on our way to establish a reputation as a key biosafety company among the international biotechnology and biopharmaceutical industry.
Products that have been tested for mycoplasma contamination in our laboratory
- Human investigational medicinal products of Phase I, Phase II or Phase III
- Biopharmaceutical market products licensed by international regulatory agencies, such as the EMA and the FDA
Studies carried out by our mycoplasma testing specialists
- Method and product-specific validations of rapid NAT-based mycoplasma detection assays
- Comparability studies for comparison of the respective detection limits of the NAT method and the compendial culture-based methods
Examples of successful experiences of our mycoplasma experts with method and product-specific validation studies for detection kit manufacturers and end-user clients:
- MycoTOOL Mycoplasma Real-Time PCR Kit (Roche)
- MycoSEQ Mycoplasma Real-Time PCR Detection Kit (Thermo Fisher Scientific/Life Technologies)
These have been used either for direct PCR testing or as hybrid assay including an enrichment step in mbsABO medium as universal rapid mycoplasma enrichment medium.