Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

Why Should You Attend:

If you use continually passaged cell lines for the production of biologics in a pharmaceutical or biotechnology setting and you do not currently test for mycoplasma contamination, awareness for the need for this testing of contamination should not be ignored or overlooked. It is estimated that 15-35% of continually cultured cell lines are contaminated with mycoplasmas. Mycoplasma contamination of a cell line does not kill the host cell, but adversely affects metabolism and slows growth. Mycoplasmas are bacteria of very small size that cannot be removed by filtration and are resistant to most antibiotics. For these reasons, controlling and testing of mycoplasma contamination of continually passaged cell lines used in the development and manufacture of biologics is paramount.

• What is mycoplasma contamination?
• What is the impact of mycoplasma contamination on the development and manufacture of biologics?
• What are the U.S. and international regulatory standards for mycoplasma testing?
• How to control mycoplasma contamination?
• What are the methods of detection of mycoplasma contamination?
• What are the resources needed for mycoplasma testing?
• How can you ensure elimination of mycoplasma from infected cultures?

This webinar will address these core questions around the subject and more.

Areas Covered in the Webinar:

• Background
• What is mycoplasma
• Number of mycoplasma species
• Need for Testing of Mycoplasma Infection
• Effects of contamination of cell lines
• Sources of infection
• Types of test samples in biological and pharmaceutical manufacturing
• U.S. and international regulatory standards
• Methods of Detection
• Direct culturing
• Indicator cell co-cultivation
• PCR
• Resources for Detection
• In-lab with commercial kits
• Commercial lab services
• Mycoplasma elimination and prevention
• Methods of eliminating mycoplasma contamination
• Processes to prevent mycoplasma contamination

Who Will Benefit:

This webinar will benefit those in the pharmaceutical, biotechnology and medical device industries that are using continually passaged cell lines for production of biologics and are not currently testing for mycoplasma contamination.

• Research and development managers, supervisors and technicians
• Manufacturing managers, supervisors and technicians
• Quality control managers, supervisors and technicians
• Senior management

Michael Simonian
Biotechnology Consultant, MHS Biotech Consulting

Michael Simonian, Ph.D., has over 30 years of experience in both basic research in academia and industry product development. Dr. Simonian is owner of MHS Biotechnology Consulting, which is a company that provides consultation and on-site laboratory services to medical device, pharmaceutical and biotechnology companies that range from start-ups to established multinational companies.

Dr. Simonian’s experience in industry includes application and product development for scientific instrumentation and research and development for in vitro diagnostic kits for infectious diseases. His experiences with scientific instrumentation includes high performance chromatography, both gel and capillary electrophoresis, and UV-visible spectrophotometers. Dr. Simonian has extensive experience both in academia and industry with animal cell culture with establishing primary cultures and use of cell culture lines. Recently, Dr. Simonian has developed and validated cell-based assays and immunoassays for medical device companies to be used in lot release testing. In addition, he has experience as a quality assurance internal auditor, root cause analysis of quality issues and risk analysis for new products.

Dr. Simonian has a Ph.D. in biochemistry and formerly was on the faculty at the University of Iowa where he taught and did basic research. He is member of the following professional societies: American Association for the Advancement of Science, American Association for Cancer Research, American Chemical Society (Division of Biological Chemistry), American Society for Biochemistry and Molecular Biology, and American Society for Cell Biology.

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