How to monitor protein impurities to ensure consistent cell and gene therapy products

February 15 2022
Live webinar

One of the main challenges of cell and gene therapies is that they are complex and often use several organisms in production. It results in a broad population of process-related impurities from different sources, such as viral proteins, host cell proteins, and growth mediums. In addition, many developers utilize rare growth mediums. With such complexity, neither ELISA, SDS PAGE, nor Western blotting can sufficiently identify and quantify the impurities. And what’s more, these traditional methods offer only minimal monitoring of individual protein impurities. Therefore, many CMC managers are turning to mass spectrometry (LC-MS) to characterize and monitor process-related impurities.

  • Find out how regulatory agencies expect you to document process-related impurities
  • Understand why the complexity of gene therapy products makes it difficult to use classical analysis methods
  • Learn how one standardized mass spectrometry assay can identify and quantify all proteins in Cell and Gene Therapy products
  • Get case examples from AAV, Lentivirus, and Adenovirus products

Tuesday 15th February 2022 8:00 PST; 11:00 EST; 16:00 GMT; 17:00 CET

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