Mycoplasma Biosafety

Mycoplasma Biosafety Services GmbH is a biotechnology service provider for GMP-compliant testing for mycoplasma contamination in the biopharmaceutical industry.

As technological market leader in mycoplasmology, we offer the most comprehensive range of mycoplasma tests by conventional culture methods and new rapid PCR-based assays. We also develop and produce culture media and reference standard products for mycoplasma testing and test validations.

Services:

  • Mycoplasma Testing according to international regulatory protocols for in-process surveillance and lot-release verification
  • Validation of mycoplasma detection assays in compliance with EMA and FDA requirements
  • Process validation for mycoplasma removal
  • Implementation of in-house quality control systems
  • Species identification & genotyping of mycoplasma contaminants
  • Root cause analysis
  • Scientific consulting and risk assessment

Mycoplasma Culture Media:

  • Ready-to-use liquid culture media and precast solid plates for mycoplasma testing according to EP 2.6.7, USP <63> and FDA/CBER guidance (1993, 2010)
  • mbsFRIIS & mbsFREY: Detection of common cultivable Mycoplasma, Acholeplasma and Spiroplasma species
  • mbsSELECT: Selective detection of highly fastidious ‘non-cultivable’ cell culture-adapted M. hyorhinis cultivar α and Ureaplasma strains
  • mbsALL: Detection of ALL common cultivable and ‘non-cultivable’ mycoplasma strains
  • mbsMHYO: rapid growth and detection of usually slow-growing, fastidious Mycoplasma hyopneumoniae strains

Mycoplasma Reference Standards:

  • Comprehensive portfolio of mycoplasma strains, including all strains referenced in EP 2.6.7, USP <63>, JP17 and FDA/CBER guidance (1993, 2010)
  • Accepted by EMA and FDA as reference standards for NAT validation
  • Mid-log phase cells from low-passage strains
  • High viability (viable/total cell ratio)
  • Low genome copy to colony forming units (GC/CFU) ratio

Precisely quantified or calibrated in colony forming units (CFU) Providing our clients of the biotech, biopharma and cell therapy industry with GMP-compliant mycoplasma testing, test validation, R&D and consultancy services and high-quality products for mycoplasma testing to contribute to the development, production and safety of biological medical products.

We are committed to fast turnaround testing with absolutely reliable and trustworthy results, excellent mycoplasma expert advisory services and a maximum level of individual client care with the permanent desire to improve its services in interaction with its customers.

Mycoplasma Biosafety Services GmbH, BioTech Center Muthgasse, Muthgasse 11/2, 1190 Vienna

+43 1 367 20 45 0