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