30-min on-demand webinar

Why we need orthogonal HCP analysis for mAbs?

- when we already have a pure mAb and a good ELISA …

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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Two of the most typical questions we hear are:

Why is it good to use an orthogonal method to ELISA for monitoring HCPs in mAb products?
Which HCPs are typically found in mAbs – and are they problematic?

In this webinar, you get an introduction to how Alphalyse investigates problematic HCPs in monoclonal antibodies – by mass spectrometry.

A) Why should you use an orthogonal method – if ELISA shows that your mAb is very pure?

Imagine that…

… 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).

The above scenario may not be as unlikely as one may think:

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

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:

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 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.

So what can you do?

It is an excellent idea to combine ELISA with a high-resolution orthogonal HCP analysis method like mass spectrometry.

Because, by using mass spectrometry, you will know which specific HCPs your mAb contains – and can evaluate if any of them may be problematic.

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.

In this 30 minute webinar, Thomas Kofoed, covers:

How we increase the limit of detection of HCPs down to 1 ppm with a mass spectrometry-based analysis.
Which individual HCPs we found in mAbs, with name and absolute quantity – even in marketed mAb products.
Examples of problematic HCPs of concern identified in several mAbs we have studied.

Who is Alphalyse?

For the past three years, we have conducted more than 150 HCP projects of mAbs and recombinant proteins using mass spectrometry.

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 give advice on which you should be aware.

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 in need of a high-resolution HCP assay.
Fear that problematic HCPs in your biologic may compromise your chances of obtaining FDA approval.

– About the webinar –

When:

On-demand

Register in less than a minute:
Just press the button and fill in your name and work email in the pop-up box.

Finish by pressing ‘Register Now.’

Next, you 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.

After the session, you will receive a replay for watching the presentation again – or you can postpone watching it for a more appropriate time.

So, don’t miss the opportunity to learn:

How mass spectrometry HCP assays bring down the detection limit.

Which problematic HCPs we have found, even in commercial mAbs.