Study: Comparison of impurity profiles & problematic HCPs – in mAbs

13 November 2020

Have you ever wondered..

  • If mAb products on the market contain small amounts of problematic Host Cell Protein (HCP) – undetected by old analysis techniques available at the time of drug development?
  • How similar the individual HCPs of biosimilars and the originator really are?

We did, and therefore set up an investigational study.

Comparison of mAb aliquots reveal several HCPs

For 5 years, Alphalyse has gathered unique insights on detailed HCP profiles of mAbs. In this respect, mass spectrometry has proven a strong HCP profile analysis tool. In particular, the technology provides details on individual HCPs in mAbs – which is impossible using ELISAs.

One of our study aims was to investigate if small amounts of problematic HCPs remain in commercial mAbs. We thus analyzed and compared numerous mAbs aliquots, generously provided by Evidentic GmbH. Additionally, a comparison was made to data from previous customer projects.

Surprisingly, we found that many samples contained small amounts of HCPs known or suspected of critical impact on product quality or patient safety.

Presentation of findings

Join our on-demand webinar where Rikke Lund presents the findings.
Learn more and register here → Comparison of impurity profiles – and problematic HCPs – in mAbs