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MS-based analysis under GMP 30 minutes on-demand webinar

#Rethink your HCP strategy

Monitor HCP clearance for expression systems without access to an ELISA

Now you can rethink your HCP assay strategy with mass spectrometry (MS)-based HCP analysis available from a GMP-certified lab. It is ideal when there is no sufficient generic ELISA for your cell line – or when the time to develop a process-specific ELISA is limited, e.g., for phase 2 and 3 clinical trials.

An MS-based assay has very high HCP coverage and sensitivity and is customizable within weeks. It even enables the identification and quantification of individual HCPs – for instance, across batches for easy comparison of purification strategies. The assay is available for full validation following ICH guidelines and thus accessible for release testing and commercial production.

Attend this 30-minute live webinar to

  • Learn how GMP accredited HCP analysis using mass spectrometry may change your HCP characterization strategy
  • Get an introduction to MS-based HCP analysis, methodology, considerations, and advantages.
  • See customer case studies on applying mass spectrometry for HCP purification optimization on E. coli and HEK293 expression systems.
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Do you find yourself in any of the following situations?

Host cell protein analysis

  • I am looking for a generic HCP ELISA, but there is no off-the-shelf assay since we use an uncommon cell line.
  • I consider developing a process-specific ELISA for better quantitation of the HCPs in my product, but we are under time pressure to find a solution.
  • I have concerns that the complexity of our therapeutic makes it challenging to develop an adequate process-specific ELISA.

If any of these scenarios fit you, you should consider a mass spectrometry-based HCP assay.

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Are you having trouble finding an HCP ELISA with sufficient coverage?

A generic E. coli or HEK ELISA kit might not be specific and sensitive enough for your product and therefore underestimate the HCP levels in your drug substance samples. Thus, you run the risk of delays if a process-specific assay shows higher levels at a later stage.

Or you may not even be able to identify a generic ELISA for your biologic – e.g., if you use Sf9, Vero, or A549 expression systems. In this case, you may already be looking into developing a process-specific assay for analyzing impurities and evaluating your purification process’ ability to reduce HCPs.

 

The development of a process-specific ELISA is time-consuming

A process-specific ELISA is created specifically for your product. It is time-consuming to develop due to the immunization of an appropriate animal host or several hosts with the HCPs. Furthermore, you may have to adjust the resulting assay until you can demonstrate sufficient coverage of the HCPs in the product.

Moreover, if you change any purification step, you might have to develop a new set of process-specific HCP antibodies, which is again cost- and time-consuming.

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Rethink your Host Cell Protein assay
Now it is fast and cost-efficient to measure and document all HCPs

This method is robust and works for all cell lines.

Based on more than eight years of research and optimization, as well as 300+ customer projects, our HCP team offers a unique HCP analysis method – which works well for all types of biologics and expression systems.

The method is based on mass spectrometry (MS) and has the unique capability of detecting and quantifying individual HCPs specific to your product – even in rare cell lines. Since the method identifies and quantifies all proteins in your sample, you can even use it to track process-related residuals and viral proteins.

This webinar points out where you can apply the assay in a typical process and what you gain from deploying it to your workflow.

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Introducing: Validated MS-based method for characterizing HCPs in biologics

In 2021, Actinobac Biomed Inc included our MS-data in their IND, which the FDA approved without requesting HCP-ELISA data. Furthermore, as the first laboratory, we have successfully validated our MS-based method to GMP-level for use on all cell lines. Thus, you can use it throughout your process and as a release assay as part of your BLA.

In this webinar, you will learn how the method applies to a typical biologic process and what you gain from deploying MS-based HCP analysis to your workflow.

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Join Thomas Kofoed for 30 minutes to get:

Thomas Kofoed

  • An explanation of how using an MS-based HCP assay solves the problem of finding an assay with sufficient coverage.
  • The overview of how GMP-based MS HCP analysis may revolutionize how you design your HCP strategy.
  • Examples of how you remove specific HCPs based on detailed knowledge about their characteristics, like pI and Mw.
Yes, show me how to #rethink my HCP strategy >>>
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We have conducted 300+ projects – so far.

Alphalyse is the world’s most experienced laboratory for MS-based HCP analysis. The BEBPA HCP conference featured talks on our method in 2017, 2018, 2019, 2020, 2021 – and we are on the agenda again in May 2022.
Our IND was approved by the FDA! They accepted the MS data without also requesting the standard HCP-ELISA immunoassay.
Scott Kachlany, founder
Actinobac Biomed Inc, USA

Examples of companies who used our services:

  • customers
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This webinar is worth your time, if:

  • You are a CMC manager looking to minimize risk and development time
  • You are a specialist struggling with inconsistent HCP ELISA kits
  • You have trouble finding a suitable generic HCP ELISA and consider developing
    a process-specific assay
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After participating, you will…

  • Have a good understanding of how to efficiently monitor HCPs throughout all process steps – using reproducible, comprehensive data
  • Know how mass spectrometry empowers you to perform intelligent process optimization and removal of impurities
  • No longer need to rely solely on HCP ELISAs but have an idea of how your process and product will benefit from applying an MS-based assay

As a bonus, you will get the opportunity to book a 1-hour meeting with one of our HCP experts to discuss how to apply the technology to your project. Of course, with no obligations.

Team up with our experienced experts:

 

Talk to our HCP experts

Our lab has conducted 300+ HCP projects so far, making us the world’s most experienced in HCP analysis of biologics by mass spectrometry:

  • Our large team of dedicated experts spent the last eight years developing and optimizing our MS-based HCP analysis
  • We apply the analysis to all process samples and expression systems, including HEK293, E. coli, SF9, A549, yeast, etc.
contact Alphalyse

What are you investing in learning more about HCP analysis by MS?

30 minutes of your time is all it takes

You may have a packed schedule, but if you sign up for the webinar, you can watch it whenever it suits you the best – we will send you a link to the recording after the live event.

Sign up for the webinar now >>>

Alphalyse Protein Analysis

– About the 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 analysis – even if you work with it daily.
  • Your generic HCP ELISA may underestimate the impurities in early process samples. Using MS will save you the trouble – and risk – of removing them in late clinical stages.
  • It’s free and only takes 30 minutes.
SURE - It’s worth 30 min of my time >>>
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