Current guidelines recommend using several orthogonal methods to determine your ELISA’s coverage of host cell protein (HCP).
Now Alphalyse and Biogenes pool our know-how and 20 years of experience in the HCP field for the combined use of our respective methods. We thus offer several HCP coverage methods:
- LC-MS-based coverage analysis (ELISA-MS™),
- Immunoaffinity Chromatography IAC combined with LC-MS, and
- 2D DIGE comparative analysis of spot patterns for HCP Coverage percentage.
You may combine these methods with LC-MS identification and quantification of relevant HCPs for a solid HCP surveillance strategy. The combination creates maximized certainty regarding HCP levels and improved HCP documentation for approval by regulatory entities.