On-demand webinar: The optimal HCP strategy 30 minutes

Design the optimal strategy for Host Cell Protein (HCP) analysis

Ensure a high drug substance output - with low HCP level

In this webinar you will learn how to design a HCP detection strategy that ensures that no critical HCPs are missed during your purification process – without the need for a null-cell line.

You get an overview and comparison of the different analysis methods, and examples of how to use them to optimize your process development. You also learn of a new coverage method that mirrors actual ELISA conditions and can be performed with just 1mg antibody!

Who? – Managers and scientists in process development or analytics

About this webinar:

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Is your impurity analysis specific and precise?

Do you experience a high variability or lack of dilutional linearity in the HCP values by your ELISA?

Are you aware of the critical HCPs that may impact your drug’s safety and stability?

Would you like to know how you can easily detect and remove specific HCPs in your purification process?

If you can answer YES to at least one of the above, this webinar is
relevant for you.

Did you know that a ‘good’ HCP analysis should …

… be able to measure the majority of proteins in the early process and should cover a broad level of HCPs?

… and have a high sensitivity and specific coverage for the few HCPs in the drug substance?

However,

Due to their generic nature, a commercial ELISA kit might have a low HCP coverage for your early stage sample and underestimate the HCP levels in your purified product.

Therefore, you should select an ELISA kit that has a high coverage of the HCPs in your specific drug.

But this is not enough

Your HCP analysis should also be able to detect critical HCPs in small amounts:

Recently, regulatory authorities have become increasingly aware of the impact certain HCPs may have on humans. Therefore, documentation of these impurities is an important part of process development.

It is important to remove critical HCPs because they may:

Cause immunologic reactions
Degrade the drug
Alter the drug

Thus, it is important

that you select a strategy that measures HCP impurities correctly and consistently – also if the process changes.

The good news is:

You can easily reduce the risk

By designing the right strategy, you can measure and document both a broad population of HCPs and specific HCPs in your final product.

In this webinar, we go over effects that critical HCPs may have on your drug, and how you can design the best analysis strategy for detection and removal of them – throughout the process.

In just 30 minutes you will get:

A comparison of the most common analysis methods (and when to use each)
Examples of critical HCPs and the harm they may cause (and why you should be very concerned)
A guide to what a ‘good’ HCP analysis strategy should contain (and the traps you should avoid)

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

Design a strategy for detecting and documenting HCP impurities in process samples and final drug

Make a detailed comparison of ELISA kits to choose the ELISA with the highest coverage of your product’s HCPs

Avoid critical HCPs based on detailed knowledge about their characteristics

We have conducted more than 100 projects
– so far

The Alphalyse laboratory is the most experienced in the world when it comes to HCP analysis based on mass spectrometry. We are the inventors of the MS-ELISA coverage method, presented at the BEBPA conference in Los Angeles last year.

Examples of companies who used our services:

This webinar is worth your time, if:

You manage a biologic’s development and want to minimize risk, cost and development time
You are a technical specialist and struggle with inconsistent commercial HCP ELISA kits
You have (the slightest) doubt about the HCPs covered by your ELISA

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

After participating, you..

Know how to select the most suitable ELISA for your biologic – with the highest HCP coverage

Have a positive understanding of the harmful effects critical HCPs may have on your drug or worse, patients

Know how to design a ‘good’ HCP analysis strategy

You will also get the opportunity to book a 1-hour meeting with one of our HCP experts to discuss your project in detail.

Team up with our experienced experts:

Our lab is the world’s most experienced in HCP analysis of biologics by mass spectrometry:

Our large team of dedicated experts spent 5 years developing and optimizing our LC-MS/MS HCP analysis and MS-ELISA coverage method
We apply the analysis to all types of process samples and all types of expression systems, including CHO, E. coli, yeast etc.
We conducted 100+ HCP projects in the past 2 years

– About the HCP Analysis Strategy webinar –

When:

On-demand

(recording from 11 March 2020)

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 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 daily
Your commercial HCP ELISA may not recognize critical individual HCPs in your biologic. Attending this webinar may save your project timeline, by showing you how to provide the right documentation needed later in the clinical stage approval
It’s free and only takes 30 minutes of your time