Mycoplasma Biosafety Services GmbH - Driving Innovation in Mycoplasma Detection, Prevention & Control
Mycoplasma Biosafety is the global technological and scientific innovation leader in mycoplasma detection, prevention and control. We offer the most comprehensive range of mycoplasma tests by the compendial culture methods and new rapid NAT-based assays, including culture media and reference standard products for mycoplasma testing, test and process validations.
Who we are
Mycoplasma Biosafety Services GmbH is a Contract Research Organization (CRO) founded in late December 2013 by two successful financial investors, DI Peter Pilz and DI Rainer Schrems, on initiative of Prof. Renate Rosengarten, who is an internationally renowned mycoplasma expert, and was the original founder and Managing Director of the previous company and niche market leader Mycosafe Diagnostics GmbH. Prof. Rosengarten is Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna and was the previous Head of the Institute of Bacteriology, Mycology and Hygiene, a renowned academic expert center in the area of basic and applied mycoplasma research. With Prof. Rosengarten and our key team, Mycoplasma Biosafety has academic roots and can look back on long-standing expertise and experience in mycoplasma detection, prevention and control. Our company is the only one in Austria and one of the few suppliers worldwide specialized in the area of Mycoplasma Biosafety services and products for mycoplasma testing.
What we do
Mycoplasma Biosafety is a supplier of high-quality GMP-compliant mycoplasma testing and related services and products. We help ensuring the absence of mycoplasma contamination in cell banks, virus stocks, biologicals, biopharmaceuticals, vaccines and ATMPs for cell therapy applications.
Beyond this, Mycoplasma Biosafety is considered as a leading consulting organization in the field of Mycoplasma Biosafety assurance. As such, Mycoplasma Biosafety acts as a competent advisor to biopharma and biotech companies and for health authorities.
Services & Products at a glance
- Product-specific PCR test validation in compliance with EMA, FDA or Japanese PMDA requirements:
- Feasibility and pre-validation studies - validation and comparability studies - spiking service
- Product-specific mycoplasma growth kinetics analysis for risk mitigation
- Process validation for mycoplasma removal, including mycoplasma retention validation of membrane filters
- GMP-compliant mycoplasma testing according to all international regulatory (compendial) protocols: EP, USP, FDA/CBER, JP, VICH
- Conventional culture methods and alternative rapid PCR methods
- Planning and execution of client-specific contract research projects
Consulting Services & Root-Cause Analysis
- Product lines specific for Pharma QC, Microbiology or Diagnostics
- Standard mycoplasma culture media mbsFRIIS & mbsFREY
- Unique media products for specific client needs, like mbsABO, mbsALPHA, mbsMHYO and mbsUREA
- Culture and DNA Reference standards of more than 20 mycoplasma type strains and 10 mycoplasma reference field strains
- Accepted by EMA and FDA for PCR validation studies
Mycoplasma Antigen Preparations for Serodiagnostic Assays
For whom we work
Our client portfolio includes research laboratories and companies from small biotech start-ups to large multinational biopharma leaders. Particularly we are planning to expand our international business operations also to the Asia-Pacific region through intensified contact with clients and distributors in that region.
History & Milestones
With Prof. Rosengarten as mycoplasma expert, original founder and entrepreneur as well as our key personnel previously employed by the former Mycosafe Diagnostics GmbH we are looking back on a long history starting from academic roots.
|12/2013||Foundation of Mycoplasma Biosafety Services GmbH by DI Peter Pilz and DI Rainer Schrems, on initiative of Prof. Renate Rosengarten|
|01/2014||Mycoplasma Biosafety Services GmbH takes over the activities of Mycosafe Diagnostics GmbH in the premises and facilities at the BioTech Center Muthgasse in Vienna|
|03/2014||Market launch of mbsABO as universal rapid mycoplasma enrichment medium|
|03/2014||Market launch of mbsALPHA, a selective culture medium for Mycoplasma hyorhinis cultivar-α strains|
|03/2014||Market launch of the first culture reference standard for Mycoplasma hyorhinis cultivar-α strains, which are considered as "non-cultivable"|
|09/2014||GMP certificate and manufacturers's authorization obtained from the Austrian Federal Office for Safety in Health Care (BASG)|
|05/2015||Market launch of mbsMHYO, a nonselective growth medium for "the 3 Mhyo" mycoplasma species, M. hyopneumoniae, M. hyorhinis, and M. hyorsynoviae|
|05/2015||Entry of ARAX Capital Partners as investor|
|07/2015||Start of a FFG -funded project focusing on the development of an innovative mycoplasma detection method|
|10/2016||First license for a mycoplasma culture media product sold|
|11/2016||Funding support obtained from the Austrian federal promotional bank aws|
|02/2017||Start of global expansion in the APAC region financially supported by the Austrian Economic Chambers WKO|
|04/2017||GreenRocket crowd funding campaign|