On-Demand webinar: Study of mAb HCP profiles 30 min

Comparison of impurity profiles – and problematic HCPs – in mAbs

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 like Humira and Gazyvaro. We now present the results from the study:

Join Rikke Lund online to hear about the analytical method and the HCPs identified – and also learn which potentially problematic HCPs we found in several of the mAbs.

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Are you curious about

Which HCPs are found in mAb products – and if any of them may be problematic?
How similar the HCP profile of a mAb biosimilar is to its originator?
How to get a sub-ppm limit of detection?

In this webinar, you get the answers to these questions with our study of 58 mAbs.

Imagine this:

… your ELISA only measures the most abundant HCPs in the drug substance.

… the sensitivity and specificity of your analysis method is not high enough to detect trace amounts of impurities.

… and 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 have a harmful effect on patients).

Wouldn’t it be nice to have known
– earlier on?

Our study shows that 50% of analyzed mAbs contain HCPs – and even problematic HCPs

But what does it mean that an HCP is problematic?

Regulatory authorities and biologics developers are increasingly aware of the impact protein impurities may have on patient safety and product stability.

It has been observed that impurities, such as host cell proteins, may:

Cause immunologic reactions in patients
Decrease drug product stability
Modify the drug function

Therefore, you must ensure

that your impurity analysis is set up during early process development to monitor HCP clearance. You should thus follow the HCPs all the way from process samples to the purified drug product – even in trace amounts.

However, HCP-ELISAs are (probably) not enough. Because they tend to be biased towards abundant HCPs and may therefore miss trace-amounts. And more importantly, an ELISA does not detect problematic HCPs, unless optimized specifically for this purpose.

So what can you do?

It is a good idea to combine ELISA with a high-resolution orthogonal HCP analysis method

With mass spectrometry, you not only measure and document a broad population of impurities in monoclonal antibodies. You also know which specific HCPs your mAb contains – even in trace amounts.

In this webinar, you first learn how the limit of detection can be improved for a more accurate HCP analysis of mAbs.

We also present to you our study of HCP profiles in mAbs on the market, including biosimilars and originators. Surprisingly, we found problematic HCPs in several, different mAbs – which may be a concern.

In this 30 minute webinar, Rikke Raaen Lund, Head of Impurity Analysis, covers:

How we increase the limit of detection with a mass spectrometry-based HCP analysis combined with native digest. And how the results compare to a regular setup.
Which individual HCPs found in our study, with name and absolute quantity – even in marketed mAb products such as Gazyvaro and Humira.
Examples of problematic HCPs of concern that were identified in several of the 58 mAbs.

Who is Alphalyse?

For the past 3 years, we conducted more than 100 HCP projects of mAbs and recombinant proteins using mass spectrometry

The Alphalyse laboratory is probably the most experienced in the world when it comes to 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 biosimilars, kindly donated by Evidentic GmbH.

Examples of companies who use our services:

You should watch this webinar if you:

Manage the process development of monoclonal antibodies.
Consult for biotech companies who are in the need of a robust HCP assay.
Fear that problematic HCPs in your biologic may compromise your chances of obtaining FDA approval.

– About the webinar –

When:

On-demand

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.

So, don’t miss the opportunity to learn..

How mass spectrometry HCP assays bring down the detection limit.

The names of the HCPs we identified in 58 mAbs.

Which problematic HCPs we found, even in commercial mAbs.