Course No 17483
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Mycoplasma contamination of biopharmaceutical products (also known as biologics or large molecules) resulting from cell culture contamination in the manufacturing process poses a potential health risk to patients. Mycoplasmas can affect virtually every cell culture parameter with often only minor visible effects, creating an uncontrollable environment that is undesirable in the pharmaceutical industry. Therefore, regulatory agencies require manufacturers to test their biopharmaceutical products and to ensure the absence of mycoplasmas in released products. Most regulatory agencies have issued guidelines that provide protocols for mycoplasma testing, and some give recommendations for the validation of rapid NAT (nucleic acid amplification techniques) testing methods. This satellite symposium will give you a scientifically sound introduction into the field of Rapid Mycoplasma testing with a specific focus on NAT and more specifically on qPCR methods. It includes talks, case studies as well as interactive round table discussions from users to users.
The satellite symposium is directed to responsible personnel involved in Quality Control testing of biopharmaceuticals and biologics, e.g.:
- QC Director, Manager, Scientists, Microbiologists, and Process Microbiologists
- Analytical Experts
- Biosafety and Pathogen Safety departments
- Bioassay Developer
- Regulatory departments
It is also useful for service providers, such as contract research organisations and contract manufacturers.
Pitfalls and Issues on Mycoplasma Testing according to Pharmacopoeial Requirements -
A Regulator´s View on ATMPs
Jan-Oliver Karo, Paul-Ehrlich Institut (PEI)
MycoTOOL – Method Development and Generic Validation Strategy
Christiana Schnitzler, Boehringer Ingelheim
Comparative Evaluation of 2 real-time PCR-based Mycoplasma Kits
Dr Christie English, Mycoplasma Experience
Automatization of Mycoplasma detection using a new fast and easy to use molecular method
Dr Félix A. Montero Julian, bioMerieux
Detection of Mycoplasma contaminations in High Cell Density Cell Cultures
Dr Alexandra Müller-Scholz, Sartorius Stedim Biotech
Mycoplasma detection system and its verification
Andrej Steyer, University of Ljubljana (co-author: Dr. Marjanca Blas, Sandoz, Slovenia)
Dr Peter Steinhardt, Roche