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Which Host Cell Protein impurities is your ELISA missing?

On-demand webinar: New HCP coverage method 30 minutes

Which Host Cell Protein impurities is your ELISA missing?

- (and avoid development of a process specific assay) -

In this webinar, you learn of a unique method to select the ELISA with the broadest coverage of HCP impurities in your purification process.

You get examples of how the method provides detailed coverage information about individual HCP impuritiess – accurately – without 2D Western blotting.

Attend if you are a manager or scientist in R&D or process development and concerned about the Host Cell Proteins (HCPs) in your biologic.

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Does this sound familiar?

You are in the early stages of development and have bought one or more commercial ELISA kits to determine the HCP amount quickly.

You experience high variability in the “coverage percent” values.

You are scared that some HCPs are not detected.

To get better coverage of HCP antibodies, you plan to develop a process-specific assay.

Do you recognize any of the above? Then, we have good and bad news.

First, the bad news:

Yes, your commercial ELISA kit might underestimate the HCP levels in your early samples – and thus pose a risk of delays if your process-specific assay shows higher levels at a later stage.

But even if you develop a process-specific assay, you are not home safe:

Because if you change one of your purification steps, you must again produce a new set of process-specific HCP antibodies and document their coverage – which is both costly and time-consuming.

Or even worse:

You may think that your current HCP documentation is sufficient for FDA/EMA. However, you might risk your deadline – or even your job – if it turns out your data omits important HCPs, due to method detection limitations.

The good news is:

You can quickly reduce this risk

Although most people don’t know it, there is another – and more efficient – way to measure and document HCP impurities in your biologic.

Through more than five years of research and optimization, our HCP team has developed a unique HCP coverage method – which can be applied to all types of biologics and process steps.

In this webinar, we point out where traditional HCP impurity analysis typically may go wrong and how you can avoid making the same mistakes:

In 4 simple steps, we will show you:

Why your current HCP analysis method may be imprecise (and sometimes misleading)
What you should do instead (and how this saves you time, money and minimizes your risk of delays)
How you should do it (this may be easier than you think)
and why you should do it (hint: There are several reasons for this)

In just 30 minutes, Head of HCP Impurities Analysis, Rikke Lund shows you how to:

Make a detailed comparison of ELISA kits (no matter your expression cell)

Choose the ELISA with the highest coverage of your product’s HCP impurities (you might be surprised how differently they each cover specific HCPs)

Copy the strategy our client used for using commercial ELISA antibodies for process samples

Minimize the risk of insufficient documentation of HCPs

I'm in! Show me how you compare ELISAs >>>

More than 200 projects have benefited already

Likewise, the Alphalyse Coverage Method received an overwhelmingly positive response from attendees at the world’s most esteemed Host Cell Protein conference, BEBPA (Los Angeles, May-2019).

Using the Alphalyse LC-MS/MS coverage method in HCP-ELISA selection, we estimate a savings of approximately $1M and, likely, one year of development time.

SAVARA Aps, Horsholm, Denmark

Lars Skriver, Senior Science Officer

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 HCP impurities covered by your ELISA

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

After participating, you..

Possess the newest knowledge on how to evaluate HCP ELISAs – without spot counting or other imprecise methods

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

Can reference examples of our 200+ HCP projects – and how our clients save up to 1 year and $1M on biologic development

In addition, you will get the opportunity to book a 1-hour meeting with one of our HCP impurity experts to discuss your project in detail. Of course, free of charge.

Team up with our experienced HCP impurity experts:

HCP impurities scientist at Alphalyse
Rikke Raaen LundPhD, Head of Impurity Analysis, Alphalyse

Our lab is the most experienced in the world for HCP analysis of biologics by Mass Spectrometry:

We spent five years developing and optimizing the Alphalyse Coverage Analysis – led by Rikke Lund and her large team of dedicated experts.
We apply the analysis to all process samples and all kinds of expression systems, including CHO, E. coli, yeast, etc.
Our team has conducted 200+ HCP impurity projects so far.

In addition:

As an industry expert we were invited to present our results at the last four BEBPA conferences.

What is your investment in how to ‘avoid selecting the wrong ELISA assay?

This webinar only takes 30 minutes of your time

The time is approx. the same as you spend trying to understand a Western Blot – and you are almost sure to save money and time in the long run if you implement our HCP impurity coverage analysis.

Start the webinar now >>>

– About the HCP impurities 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 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.

Are you 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 impurity analysis – even if you’re working with it daily.
Your commercial HCP ELISA may not recognize critical individual HCP impurities in your biologic. Attending this webinar may save your project timeline by showing you how to provide the proper documentation needed later on in the clinical stage approval.
It’s free and only takes 30 minutes of your time.

SURE - It’s worth 30 min of my time >>>

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