Our client had used commercial HCP ELISAs for Host Cell Protein analysis during early process development but found that the measured HCP levels were inconsistent. Thus, they decided to support their HCP analysis using a complementary method – mass spectrometry.
This particular European biopharma company develops highly targeted immunotherapies for cancer patients. They specialize in immune activators that target hard-to-treat solid tumors.
They established contact to Alphalyse after referral from their CMO, which already collaborated with Alphalyse on several projects. Previously, the company used commercial ELISA kits for HCP analysis but found that they were not that reproducible and consistent in the determined HCP amounts.
Therefore, they were looking for a more robust and reproducible HCP analysis for the total HCP amount in final batch samples, along with detailed information about individual HCPs. Once they received the first results, they could easily compare impurity levels between different batches.
Lessons learned: Never rely on just a single method for your HCP analysis.