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