Methods for Detecting Mycoplasma Contamination In The Manufacture Of Pharmaceuticals and Biologics
Duration : 90 Minutes
This course covers the aspects of mycoplasma contamination that impact the manufacture of pharmaceutical biologics. If continually passaged cell lines are used for the production of biologics in a pharmaceutical or biotechnology setting, the need for testing of mycoplasma 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.
Course Objectives:
This course will help the attendee understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as will the methods of mycoplasma detection. Also the resources for testing will be described.
Course Outline:
Attendees will leave the Course clearly understanding of how mycoplasma contamination impacts pharmaceutical biologics manufactured with cell cultures. At the conclusion of this webinar, the attendee will have the knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting. Specifically the areas that will be covered include:
• A description of what are mycoplasma.
• The impact of mycoplasma contamination on the development and manufacture of biologics.
• The regulatory standards & guidelines for mycoplasma testing.
• Methods of mycoplasma detection.
• Resources for mycoplasma testing.
• Elimination of mycoplasma from infected cultures.
• How to control mycoplasma contamination.
• Background – What is mycoplasma
• Characteristics and effects of mycoplasma contamination
• Need for testing of mycoplasma infection
• Methods of detection
• Resources for detection tests
• Mycoplasma elimination and prevention
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This 90-minute overview 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. The course will benefit the following stakeholders.
• Research and development managers.
• Supervisors and technicians.
• Manufacturing managers.
• Quality control managers.
• Senior management professionals.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
