Is the “needle in the haystack” ruining your mAb product?
Determining the HCP amount to a sparse sum using ELISA does not rule out that the product may contain ‘problematic’ HCPs – that may degrade the product or alter the function.
Watch this webinar to learn why you need an orthogonal method to ELISA to investigate your mAb for potentially problematic HCPs – down to and below 1ppm.
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… your ELISA shows that your mAb drug contains only a low level of HCPs.
… however, late in the process, it is discovered that one or more HCPs in low amounts is problematic. For instance, because it degrades the product (or worse, causes immunogenic reactions in patients).
Regulatory authorities and biologics developers are increasingly aware of the impact protein impurities may have on patient safety and product stability.
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.
However, HCP-ELISAs tend to be biased towards abundant HCPs. Therefore, they may not detect problematic HCPs in small amounts unless explicitly optimized for this purpose.
In this webinar, Thomas Kofoed explains the unique digest method our scientists use to lower the limit of detection of HCPs even down to 1 ppm in mAbs.
You will also learn which problematic HCPs we have found in several mAbs – and why they may be of concern.
The Alphalyse laboratory is probably the most experienced in the world for HCP analysis by mass spectrometry.
We have thus analyzed approx 60 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 and advise on which you should be aware.
When:
On-demand
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