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December 1 Detailed HCP coverage 30 minutes

3 reasons to check the coverage of your HCP-ELISA

- even if you are still in the early clinical phases

In just 30 minutes you will learn how to use ELISA-MS™ coverage analysis to

a) Make ELISA kit bridging studies – when your supplier switches to a new batch of capture and detection antibodies

b) Check if the coverage of your ELISA is good enough – especially for uncommon expression systems

c) Select the ELISA that best covers specific HCPs in your product or HCPs of concern for product stability and patient safety

You will see plenty of examples from client projects – using E. coli, CHO, and HEK cell lines – without a null cell line and with a low amount of antibody.

Presented by Ejvind Mortz, PhD

Ejvind Mortz presentation on HCP strategies and impurities in gene therapies

Live on 1 December, 16.30 CET / 7.30 PST / 10.30 EST

Not a good time for you? Sign up and receive a link to the recorded webinar

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Date: 1 December 2021
Time: 16.30 CET | 7.30am PST | 10.30am EST


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About this webinar:

  • What you will learn

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  • Meet the experts

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YES - I want better coverage information >

Does this sound familiar?

Host cell protein analysis

  • You have bought one or more commercial ELISA kits to determine the HCP amount quickly.
  • You experience high variability in the HCP values provided by the ELISA.
  • You received a notice that your supplier is running out of the ELISA antibodies you are using.
  • You plan to develop a process-specific assay to get better coverage of HCP antibodies.

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

contact Alphalyse

First, the bad news:

A commercial ELISA kit might underestimate the HCP levels in your early samples, and it may miss some HCPs of concern.

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

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

Or even worse:

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

protein analysis services

The good news is:

You can quickly reduce this risk

It is possible to investigate if your ELISA measures and documents all essential HCPs in your biologic.

In this webinar, we point out where ELISA analysis typically goes wrong and how you can avoid making these mistakes.

You will learn:

  • Why your ELISA may be imprecise (and sometimes misleading)
  • What you can do to check it (and how this saves time, money and minimizes your risk of delays)
  • How to do it (it may be easier than you think)
  • and why it is a good idea to do it (there are several reasons for this)
contact Alphalyse

In 30 minutes, Ejvind Mortz shows how to:

Ejvind Mørtz, Alphalyse

  • Make a detailed comparison of ELISA kits (no matter the expression cell)
  • Choose the ELISA with the highest coverage of your product’s HCPs (you might be surprised how differently they each cover specific HCPs)
  • Copy the strategy our clients use for using commercial ELISA antibodies for process samples
  • Minimize the cost of coverage analysis by using ELISA-MS™ which does not require a null-cell line and only a small amount of antibodies
I'm in! Show me how you compare ELISAs >>>
protein analysis services

More than 100 clients benefited from our HCP services 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 ELISA-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:

  • customers
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  • customers

This webinar is worth your time, if:

  • You are a CMC manager and want to minimize risk, cost, and development time
  • You are a technical specialist and struggle with inconsistent commercial HCP ELISA kits
  • You are unsure if your ELISA covers all the essential HCPs in your drug product
  • Your supplier ran out of the antibodies you used for your early process samples
  • Your ELISA shows dilutional linearity
  • ….
contact Alphalyse

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
  • Have seen examples of our 200+ HCP projects – and how our clients save up to 1 year and $1M on biologics 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 detail. Of course, free of charge.

Team up with our experienced experts:

Alphalyse CRO Denmark and USA

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

  • The Alphalyse ELISA-MS™ Coverage Analysis took five years of development and optimization.
  • Our team has conducted 200+ HCP projects so far.
  • As the industry experts, we presented our results at the last four BEBPA conferences – by invitation from the organizers.
protein analysis services

The webinar only takes 30 minutes of your time

The time is approx. the same as you may spend trying to understand a Western Blot or eat your lunch. And you are almost sure to save money and time in the long run if you implement the ELISA-MS™ coverage analysis.

Sign up now >>>
contact Alphalyse

– About the HCP coverage webinar –

When:

1 December
16:30 CET | 3.30pm GMT | 7.30am PST | 10.30am EST
30 minutes including Q&A

If you are unable to participate in the live session, you can watch a replay.
Just register before 1 December, and we will send you the replay link.

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.

CRO Denmark

Are you still unsure if you should sign up?

Here are three 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 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 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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