30 min on-demand webinar Method successfully applied to 150+ projects!

HCP analysis using LC-MS – for data driven process development

Would you like to follow process-related impurities (host cell proteins) when you…

Change CMO…
Scale up the production process…
Change a major part of the purification process…

…without setting up a new HCP ELISA?

Join us to see results from using our mass spectrometry based method, including examples of customer data.

About this webinar:

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Which of the following situations apply to you?

I’m in the early stages of development and have begun looking into HCP analysis – and the best way to do it.
I perform HCP analysis based on HCP ELISAs but am concerned how to use them to identify critical HCPs that may impact my drug’s safety and stability.
I am in the process of scaling our production or switching CMO – and I need a detailed profile of the HCP content in different batches for comparison.

If you recognize any or more of the above scenarios, you will benefit from an orthogonal HCP analysis based on mass spectrometry.

Did you know this about HCP ELISAs?

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.

Even if you develop a process-specific assay, you may still run into problems:

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:

Your current HCP documentation may not be sufficient for authorities. It is up to you to document that the HCP levels are sufficiently low – and that there are no problematic HCPs present. You might risk missing your deadline – if it turns out your data omits important HCPs, due to method detection limitations.

But don’t panic:

It is easy to support (or replace) your HCP ELISA with this proven technology

There is another – more efficient and robust – way to measure and document HCP in biologics.

Based on more than 5 years of research and optimization and more than 150 customer projects, our HCP team has developed a unique HCP analysis method – which works well for all types of biologics and expression systems.

In this webinar, we point out where in a typical biologic’s process the method can be applied and what you gain from deploying it to your workflow.

Spend 30 minutes with Thomas Kofoed, Co-founder of Alphalyse, to get:

Examples from a customer case where the analysis was used to optimize a 6-step purification process
Explanation of how an LC-MS based HCP assay provides early detection of problematic HCPs – with examples of specific HCPs known to have delayed clinical trials
Insights on how to use the technology to compare PPQ runs and HCP clearance – for Biologics License Application (BLA)
Input on future HCP test strategy – based on what industrial experts foresee and observe from regulatory agencies

More than 150 customer projects with the analysis

Moreover, the analysis has been featured in presentations several times at the world’s most important Host Cell Protein conference; BEBPA (2017, 2018, 2019, and 2020).

With Alphalyse results, we intelligently removed the HCPs and have shortened the processes with at least one year compared to previous projects

Senior Manager, Process Development

Clinical-stage biotech company

Examples of companies who used our services:

Don’t miss this webinar 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 wish to easily reduce the HCP level and remove specific HCPs in few, efficient purification steps
You work with an uncommon expression organism that does not yet have a suitable HCP ELISA

Or simply want to brush up on the newest technologies for Host Cell Protein analysis.

After participating, you..

Have learned how to efficiently monitor HCPs throughout all process steps – using reproducible, comprehensive data

Know of a method that lets you skip purification matrices and instead perform intelligent process optimization

Can reference examples of our 150+ HCP projects – and how our clients save up to 1 year and $1M on biologic development

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 own project. Of course, free of charge and with no obligations.

Team up with our experienced experts:

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

We spent more than 5 years developing and optimizing the Alphalyse HCP analysis – led by Rikke Lund and her 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 150+ HCP projects in the last 2 years.

What are you investing to learn more about HCP analysis by LC-MS?

30 minutes of your time is all it takes

You may have a packed schedule at the moment, but if you sign up for the webinar, you can watch it whenever it suits you the best – it is available on-demand.

– About the webinar –

Register in less than a minute:
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, which you can watch immediately – or later, whenever it suits you.
The broadcast works in all web browsers, and on all devices (laptop, PC, phone) – and there is no need to download anything.

Still wondering if you should sign up?

Here are 3 reasons why you should not miss out:

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 obtain comprehensive data about the HCP profile, including the identity and quantity of individual HCPs.
It’s free and only takes 30 minutes of your time

HCP analysis using LC-MS – for data driven ​​​​​​​process development