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Analysis of Process Related Impurities in Cell & Gene Therapy Products by SWATH LC-MS

The manufacturing process for cell and gene therapies is complex and can contain process-related impurities from multiple organisms. A commercial host cell protein (HCP)-ELISA kit is often not available for the cell line or is not suitable for the specific process due to a low HCP coverage. Development of a process-specific ELISA can be unfeasible as the product often requires a short development time.

HCP analysis by SWATH LC-MS is overcoming several of these challenges and has multiple advantages:

  • Enables quantification of the total HCP amount in ng/ml drug substance
  • Identifies and quantifies each individual HCP
  • Provides identification and quantification of each individual viral protein
  • Identification of other process related impurities, such as benzonase, and bovine serum albumin.

By attending this webinar, you will learn:

  • Regulatory guidelines for process-related impurities in cell & gene therapy products
  • How to identify and quantify protein impurities by SWATH LC-MS for process consistency and product purity
  • Case examples of immunotherapy products based on oncolytic viruses in human cell lines

Ejvind Mortz, PhD.
Ejvind Mortz, PhD.
Co-Founder & COO, Alphalyse