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Company

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

Validation Services

  • 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

Mycoplasma Testing Services

  • 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

Contract Research Services 

  • Planning and execution of client-specific contract research projects

Consulting Services & Root-Cause Analysis

Mycoplasma Culture Media

Mycoplasma Reference Standards

  • 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
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