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.
Co-Founder & COO, Alphalyse