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30 min on-demand webinar

Which Host Cell Protein impurities is your ELISA assay missing?

A new reproducible method for detecting which individual impurities are measured
New HCP Coverage Method!

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

You get examples of how the method provides you with detailed coverage information about individual HCPs – 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.


Does this sound familiar?

Host cell protein analysis

 

  • You are in in the early stages of development and have bought one or more commercial ELISA kits to quickly determine the HCP amount.
  • You experience a high variability in the “coverage percent” values.
  • You are scared that some HCPs are not detected.
  • To get a 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.

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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 proces 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 develop 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.

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The good news is:

You can easily reduce this risk

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

Through more than 5 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 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)
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In just 30 minutes, HCP Team Leader Rikke Lund shows you how to:

HCP analysis - coverage percentage by mass spectrometry

  • Make a detailed comparison of ELISA kits (no matter your expression cell)
  • Choose the ELISA with highest coverage of your product’s HCPs (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

More than 75 projects have benefitted from the analysis already

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

…and here’s what one of our recent clients gained from the analysis:

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
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Examples of companies who used our services:

  • customers
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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.

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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 75+ 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 experts to discuss your project in details. Of course, free of charge.

Team up with our experienced experts:

 

Scientist at Alphalyse
Rikke Raaen Lund
PhD, HCP Team Leader, Alphalyse

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

  • We spent 5 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 types of process samples and all types of expression systems, including CHO, E. coli, yeast etc.
  • Our team conducted 75+ HCP projects in the past 24 months

In addition:

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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 certain to save money and time in the long run if you implement our coverage analysis.

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And there’s more:

Bonus
By signing up you may schedule a free session with our HCP experts for input on your own project - for free of course

– About the HCP coverage 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.

 

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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’re working with it on a daily basis.
  • 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 on in the clinical stage approval.
  • It’s free and only takes 30 minutes of your time
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