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25th August 2014  Content supplied by: LABS, Inc.

Mycoplasma Testing for Cell Therapy Products


LABS, Inc., a clinical reference testing laboratory serving the transplantation community, have a white paper available on Regulatory Aspects of Mycoplasma Testing for Cell Therapy Products written by experienced testing professionals Russell C. Marians, Ph.D., Matthew Brenton, Stacey LaBombard, Aaron Schieving, Sara Dionne, Ph.D., and Michael Bauer, M.D.

This paper will be of interest if you are involved in the research, development, manufacturing, quality assurance or commercialization of stem cell and regenerative medicine products, the paper tracks the progression of culture-based testing methods to the use of PCR based mycoplasma testing currently being considered by the U.S. Food and Drug Administration (FDA) in lot release tests for all biologics, including cell therapies.

Some examples of the valuable information you will find in the White Paper:

  • Culture-based mycoplasma testing is currently the method most commonly approved by the FDA for lot release testing of biologics, cell therapies and viral vaccines.
  • PCR-based mycoplasma testing has not been universally approved for release of clinical material or marketed product.
  • PCR-based mycoplasma testing can be the most viable option available in your product development process.
  • LABS, Inc has validated the MycoSEQ™ Mycoplasma Detection Kit from Life Technologies for mycoplasma testing.
  • After sample qualification, the MycoSEQTM test can currently be used to assess the presence of mycoplasma in raw materials and media components, primary cells, research materials, product intermediates, and early phase clinical products, with FDA advisement.

To download the paper (registration is required) visit www.labs-inc.org


    

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Date Published: 25th August 2014

Source article link: http://www.labs-inc.org/regulatory-aspects-mycoplasma-testing-cell-therapy-products-white-paper/?utm_source=alert&utm_medium=website&utm_campaign=mycoplasma%20white%20paper


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