Last week we got exciting news:
FDA approved an Investigational New Drug Application (IND) for one of our clients who used ONLY our mass spectrometry data – NO ELISA data – to analyze the host cell proteins (HCPs) in their biological drug.
The approval marks a significant advancement for HCP analysis by mass spectrometry, where HCP-ELISA has been the classical approach. It paves the way for using LC-MS data in regulatory documentation, perhaps even for testing for specific, problematic HCPs in commercial manufacturing.
Moving HCP LC-MS analysis into a GMP environment
Many people ask us when it will be possible to use LC-MS as a release assay for HCP analysis under Good Manufacturing Processes (GMP).
So far, it has been challenging to move the analysis into GMP-compliant laboratories:
The complexity of the sample preparation and data analysis, the sophistication of the high-end mass spectrometers, and the lack of reproducibility of the complete workflow have stopped many from trying or succeeding.
Therefore, at the virtual BEBPA Host Cell Protein Conference last week, we presented the measures Alphalyse has put in place to control and monitor the variabilities.
If you like to hear the presentation, please watch our webinar.
- Is it possible to transfer the method to the GMP level?
- Which parameters are most important to track?
- Data from the assay qualification