“Before mass spectrometry, we were blind.”
Margarita Sabater, senior CMC specialist at Genmab, recently highlighted the limitations of ELISA for effective problem-solving in mAb development.
She described immunoassays as “a ‘black box’ unable to identify the root cause of issues such as immunogenicity or polysorbate degradation.”
However, despite the increasing focus on host cell proteins (HCPs) in both research and regulatory legislation, it is still not uncommon to hear the following statements from biopharmaceutical developers:
“We have never seen HCPs in our final drug samples, so this seems more like a theoretical issue.”
Or, “Our ELISA does detect HCPs, but the levels are too low to be concerning.”
As Margarita pointed out in her webinar on Genmab’s HCP control strategy for mAbs, ELISA alone can’t differentiate between harmless and potentially harmful HCPs - and may not detect all HCPs in a sample.
This is why Genmab uses mass spectrometry (LC-MS) to optimize processes and ensure product consistency - saving time and other resources.
Discover more about Genmab’s HCP control strategy in our CMC webinar series: alphalyse.com/genmab