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European Biopharmaceutical Review

Rapid Methods

Testing for the absence of mycoplasmas is an essential part of quality control (QC) measures in biopharmaceutical production processes. However, the detection of mycoplasmas by traditional culture methods, as required by official regulatory protocols, sometimes poses a major challenge. Hurdles include their small cell size, the wide diversity of species, the cell invasiveness of some species, their special nutrient requirements, the limited generation of turbidity in liquid culture and the non-cultivability of some species and strains in standard mycoplasma growth media. Therefore, low-grade mycoplasma contaminations might go unrecognised for a long time, as a number of spectacular mycoplasma contamination cases have previously shown. The often catastrophic consequences are lost production time and considerable revenue losses.

Despite extensive recent efforts to develop and implement nucleic acid amplification techniques (NAT) for rapid mycoplasma detection as in-process control and release tests, the number of biologics approved by regulatory authorities using such assays is still very low. However, recent developments, technical improvements and increased experience with product-specific validation approaches have enabled the establishment and regulatory approval of rapid NAT-based test systems as early warning systems for in-process control testing and for lot release testing. The combination of these rapid tests with the latest innovations in automated sample preparation instrumentation allows cost-effective sameday high-throughput testing to reliably exclude the presence of mycoplasmas throughout the entire production process until lot release. Due to their considerable advantages, they are expected to be used increasingly in the future to replace traditional culture methods for regulatory mycoplasma testing. This could revolutionise QC and lot release in the biotechnology and biopharma industries.

Safety Issues

Mycoplasmas are true bacteria, but they lack a cell wall, making them less rigid and much more pleomorphic than ‘classical’ bacteria (1). Due to their plasticity in cell morphology and their small cell size, mycoplasmas pass 0.1μm ‘sterilising grade’ filters. This is one reason why they are of major concern as potential contaminants of cell culture-derived biologics, particularly as bioreactors provide favourable conditions for mycoplasma growth. They are also prevalent in humans, animals, plants and insects, so, in principle, any animal- or plant-derived raw material used in biopharma production processes or R&D can potentially contain mycoplasmas. Another point to consider is that, through biofilm formation, some mycoplasmas are even capable of longterm survival in the environment (2).

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Professor Renate Rosengarten DVM, PhD, has been Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna, Austria, since 1996. Beside numerous academic research activities and functions, she has almost 15 years of experience in entrepreneurship, business and leadership in the biotech area. She was founder and Managing Director of the niche market leader Mycosafe Diagnostics GmbH, which she re-established as Managing Partner in 2014 under the company name Mycoplasma Biosafety Services GmbH. As a scientific and business expert with an extensive network in the biotech, biopharma and academic research communities, she serves as a consultant to the company and its business expansion worldwide.

Dr Carl-Ulrich Zimmerman PhD is Head of R&D at Mycoplasma Biosafety Services GmbH and holds a doctorate in molecular biology from the University of Heidelberg, Germany. As a postdoctoral scientist at the University of Veterinary Medicine Vienna, Austria, he dedicated almost 10 years to basic mycoplasma research. Carl-Ulrich joined the company in 2014 and is the driving force behind all contract research and innovation projects.

Dr Martina Sauert PhD is Chief Operations Officer at Mycoplasma Biosafety Services GmbH and has been driving the international business development and public relations since joining the company in late 2016. She holds a PhD in molecular microbiology from the University of Vienna, Austria, and provides clients, partners and the interested public with profound background knowledge on mycoplasma detection and the company’s services and products.

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Professor Renate Rosengarten
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Dr Carl-Ulrich Zimmerman
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Dr Martina Sauert
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