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:

 

1. Enables quantification of the total HCP amount in ng/ml drug substance

2. Identifies and quantifies each individual HCP

3. Provides identification and quantification of each individual viral protein

4. Identification of other process related impurities, such as benzonase and bovine serum albumin

 

Learning Objectives