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Mycoplasma Testing for the 21st Century



Russell C. Marians, PhD., Sr. Scientist, Manager, Molecular and Cell Biology, LABS, Inc.

Dr. Russell Marians joined LABS, Inc. as a Senior Scientist in 2010, and was promoted to Manager of Molecular and Cellular Biology in 2012. He also serves on the Scientific and Technical Advisory Committee of the American Association of Tissue Banks. Previously, Dr.Marians conducted research at Taligen Therapeutics. His work on developing key PK/PD assays for preclinical studies, manufacturing processes development, production clone selection, and target validation, was instrumental in the sale of Taligen to Alexion Pharmaceuticals for $111 million. Dr. Marians received his PhD from the Mount Sinai Graduate School of Biological Sciences in 2001, and was a post-doctoral fellow at the University of Colorado.

Webinar Info

Use of a rapid, real-time PCR–based detection method for Mycoplasma detection enables in-process monitoring throughout the cell culture manufacturing process and helps to enable the earliest possible detection of a contamination event. Benefits of in-process testing include:

• Rapid time-to-results (typically 4-5 hours)
• Helps you qualify suppliers and source materials
• Enables you to perform risk assessment
• And helps with root-cause analysis

Viral contamination, including MMV and Vesivirus, is a potential threat to mammalian cell culture manufacturing processes. Many cell culture manufacturing facilities have been negatively impacted following contamination with these viruses.

The MycoSEQ^™ Mycoplasma Detection Kit allows for highly specific and comprehensive contamination species detection and prevents the detection of other closely related species, with benefits including:

• Detection of greater than 90 species
• Demonstrated sensitivity and specificity
• And efficient sample preparation with high DNA yields

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• Area of Bioprocessing *
  Upstream (i.e. cell line development, cell culture, cell therapy)Downstream (i.e. purification, chromatography, pre-packed process scale columns)

  Pharma Microbiology (i.e. QC micro)Biopharma Process Analytics (i.e. bacterial/fungal id, mycoplasma detection, micro virus detection)
• The contaminants you currently test for are (check all that apply): *
  MycoplasmaMouse minute virusVesivirus

  Other virusesNot presently testing for contaminants, but will have a need in the near future
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• Which of the following impurities do you currently analyze? *
  Residual host cell DNA testingResidual Protein AHost Cell Proteins
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  CHOE.coliMDCKHuman

  PicchiaVeroOther
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