On-demand Webinar Cell & gene therapies 30 minutes

Are you ready for FDA
questions about impurities?

WHAT to measure - and HOW

When you submit an IND for a Cell or Gene Therapy product, guidelines state that you must measure process-related impurities in the drug substance and monitor process performance parameters for process consistency.

Often there is no impurity ELISA available – or the host cell protein (HCP) coverage of the ELISA is low. So how do you find a good impurity assay?

In 30 minutes, you get an overview of the documentation guidelines for process-related impurities in cell and gene therapies. You are also introduced to a mass spectrometry method to monitor multiple proteins with one assay.

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How do you document process related impurities in cell and gene therapies?

Do you have trouble finding an ELISA covering all proteins present in your product from the expression system?

Is the coverage of your ELISA lower than expected?

Would you like to know how you can easily quantify specific process-related impurities?

If you work on gene therapies and answer YES to at least one of the above, this webinar is relevant to you.

Do you know that a good impurity assay for gene therapies should …

… be able to measure the majority of proteins in the early process and cover HCPs that could potentially end up in the product?

… detect with high sensitivity and specificity the few impurities in the drug substance?

However,

Cell and gene therapies are much more complex than recombinant protein drugs. Often several organisms are used to produce the product. This results in a broad population of process-related impurities from different sources, such as viral proteins, host cell proteins, and growth medium.

With this complexity, it can be challenging to find a suitable commercial HCP ELISA kit to handle the challenge. Therefore, many cell and gene therapy developers search for an alternative to ELISA. Especially since the development of a sufficient ELISA assay could take years – if it is even possible?

But why are process-related impurities a concern?

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

They observed that host cell proteins may:

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

Therefore, you should

setup an impurity analysis in early process development. Then you can monitor HCP clearance all the way from process samples to the purified drug product.

Good news:

This method completely outmatches ELISA

With mass spectrometry, it is easy to measure and document both a broad population of impurities and specific HCPs in cell and gene therapies.

In this webinar, we both go over the guidelines for cell and gene therapies. And we show how to analyze the entire HCP population in complex biopharmaceutical products using mass spectrometry.

In just 30 minutes, Ejvind Mortz, COO and Head of Development, covers:

A walk-through of the newest impurity guidelines from the regulatory agencies.
The short explanation of how mass spectrometry can quantify all protein impurities.
How to select a suitable ELISA with the highest HCP coverage.
Customer cases that show you how clients applied mass spectrometry analysis to their cell and gene therapies.

We have conducted more than 100 projects – so far

The Alphalyse laboratory is probably the most experienced in the world when it comes to HCP analysis by mass spectrometry. In 2020 we were the first to present a comparison of HCPs found in commercial mAbs – including a list of impurities of concern.

We believe that mass spec can replace ELISA as the HCP analysis approach for our future projects.

European biopharma company

Chief Scientific Officer

Examples of companies who used our services:

This webinar is worth your time if you:

Manage the process development of cell or gene therapies.
Consult for a company that cannot find or develop a suitable ELISA.
Have (the slightest) doubt about the impurity guidelines for cell/gene therapy products.

Or simply if you have an interest in the newest technologies for Host Cell Protein analysis.

After participating, you…

Know how regulatory agencies prefer the documentation of process-related impurities.

Have seen examples of results from HCP analysis of gene and cell therapies.

Understand how mass spectrometry can be applied to products originating from multiple expression systems.

– About the webinar –

When:

On-demand

It takes less than a minute to register:
Just press the button, select your preferred time slot and fill in your name and work email in the pop-up box.

Finish by pressing ‘Register Now.’

After signing up, you will receive an email with a link to the webinar.
It works in all web browsers and on all devices (laptop, PC, phone) – with no need to download anything.

Still wondering if you should sign up?

Here are 3 reasons why it’s worth your time:

You will get a new perspective on the concept of HCP analysis – even if you work with it on a daily basis.
Attending this webinar may save your project timeline, by showing you how to provide the right documentation needed later on in the clinical stage approval.
It’s free and only takes 30 minutes of your time.

Are you ready for FDA questions about impurities?