Or, how similar the HCP profile of a mAb biosimilar is to the originator?
Alphalyse used a unique mass spectrometry-based assay to analyze and compare HCPs in more than 50 mAbs, including 16 commercial mAbs. We now present the results from the study:
Join Rikke Lund online to hear about the analytical method and the HCPs identified and learn which potentially problematic HCPs we found in several mAbs.
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… your ELISA only measures the most abundant HCPs in the drug substance.
… the sensitivity and specificity of your analysis method are not high enough to detect trace amounts of impurities.
… consequently, late in the process, one or more of the HCPs in trace amounts turn out to be problematic. For instance, when it is discovered that it degrades the product (or worse, it may harm patients).
Regulatory authorities and biologics developers are increasingly aware of the impact protein impurities may have on patient safety and product stability.
Literature describes that impurities, such as host cell proteins, may:
that your impurity analysis is set up during early process development to monitor HCP clearance. You should thus follow the HCPs from process samples to the purified drug product – even in trace amounts.
However, HCP-ELISAs are (probably) not enough – because they tend to be biassed towards abundant HCPs and may therefore miss trace amounts. And more importantly, an ELISA does not detect problematic HCPs, unless explicitly optimized for this purpose.
In this webinar, you first learn to improve the detection limit for a more accurate HCP analysis of mAbs.
We also present our study of HCPs in mAbs on the market, including biosimilars and originators. Surprisingly, we found problematic HCPs in several different mAbs – which may be a concern.
The Alphalyse laboratory is probably the most experienced in the world regarding HCP analysis by mass spectrometry.
We have thus analyzed 58 purified mAbs with our method, representing 30 different mAbs. Therefore, we are in a unique position to provide a general overview of HCPs identified in monoclonal antibodies.
For this specific study we also analyzed and compared 16 commercial mAbs and biosimilar drugs, kindly donated by Evidentic GmbH.
When:
It takes less than a minute to register:
Just press the button and fill in your name and work email in the pop-up box.
Finish by pressing ‘Register Now.’
After that, you will receive an email with a link to the webinar (usually within a few minutes).
You can use any web browser and your favorite device (laptop, PC, phone). And you may also be happy to know that there is no need to download anything.
