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Cell & gene therapies 30 minutes on-demand webinar

How to monitor impurities and ensure consistent gene therapies

One of the biggest challenges in developing advanced therapy medicinal products and viral vaccines is ensuring and documenting that the downstream process consistently produces a safe product.

Neither ELISA, SDS PAGE, nor Western blotting can sufficiently identify and quantify process-related impurities in the complex products. And what’s more, these traditional methods offer only minimal monitoring of individual protein impurities.

Do you know the new solution (LC-MS) that more and more C&GT companies turn to?

In this webinar, you will learn how to quickly identify and quantify all proteins using only one assay – irrespective of the source of the proteins.

Presented by Ejvind Mortz, PhD

Ejvind Mortz presentation on HCP strategies and impurities in gene therapies
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How do you analyze complex products?

How do you document process related impurities in cell and gene therapies?

Host cell protein analysis of gene therapies

  • Do you have trouble finding an ELISA that covers all proteins in cell and gene therapy product?
  • Is the coverage of your ELISA lower than expected?
  • Would you like to know how you can easily quantify specific process-related impurities – regardless of source?

This webinar is relevant to you if you can answer yes to at least one of the above.

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FDA is seeking more consistency from cell and gene therapy developers

The Food and Drug Administration is increasingly pressing cell and gene therapy developers to more consistently measure the characteristics of their complex products.

What does that mean?

In short, developers must pick some essential characteristics or attributes to monitor consistently. The six new guidance documents for drugmakers, released by FDA last year, mention process-related impurities as one of such characteristics.

One of the main challenges is that cell and gene therapies are very complex, and often several organisms are used to produce the product. This results in a broad population of process-related impurities from different sources, such as viral proteins, host cell proteins, and growth mediums. In addition, many developers utilize rare growth mediums.

With such complexity,

many CMC managers find it challenging to find a suitable commercial HCP ELISA. Further, the short development time for some products does not allow for the development of a process-specific ELISA. Therefore, they search for an alternative to ELISA, and many are now turning to LC-MS analysis to characterize and monitor process-related impurities.

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But why are process-related impurities a concern?

Regulatory authorities like FDA have become increasingly aware of the impact protein impurities may have on patient safety and product stability.

They observe that specific proteins may:

  • Cause immunologic reactions in patients
  • Decrease drug product stability
  • Modify the drug function

Therefore, it is important

to set up an impurity analysis in early process development. Then you can monitor HCP clearance from process samples to the purified drug product.

But, did you know?

You only need one standardized, comparable assay for proteins from multiple sources

Mass spectrometry (LC-MS) provides unrivalled quantification and high reproducibility of each protein impurity in cell and gene therapies.

In this webinar, you will see

  • how it is possible to measure the entire HCP population in complex biopharmaceutical products using mass spectrometry.
  • real examples of the data provided for cell and gene therapy companies.
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Ejvind Mortz, COO and Head of Development shows:

Ejvind Mørtz, Alphalyse talks on impurities in gene therapies

  • How to live up to the impurity guidelines from the regulatory agencies.
  • Understand how mass spectrometry can differentiate and identify all protein impurities down to low ppm in concentration.
  • Quantify individual protein impurities
  • Client stories and data showing you how peers apply mass spectrometry analysis to their cell and gene therapies.
Show me how to document impurities >>>
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Proven technology you can trust

You’re in safe hands with our LC-MS experts. To date, our clients received data for 300+ HCP projects for cell and gene therapies, mAbs, vaccines, and therapeutic proteins.
We went from inconsistent, low-coverage ELISAs to reproducible and detailed HCP analysis
European biopharma company
Chief Scientific Officer

Examples of companies who used our services:

  • customers
  • customers
  • customers
  • customers
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  • customers
  • customers
  • customers

This webinar is a must-attend if:

  • Are a CMC manager involved in the process development of cell or gene therapies.
  • Consult for a company that cannot find or develop a suitable ELISA.
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By participating, you will…

  • Find out how regulatory agencies expect you to document process-related impurities.
  • Be able to reference several examples of results from LC-MS analysis of gene and cell therapies.
  • Understand why mass spectrometry is such a strong method for analyzing products originating from multiple expression systems.
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– About the webinar –

When:

On-demand

 

It takes less than a minute to register:
Just go to the top of the page and fill in your name and work email in the sign-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 not sure if this webinar is worth your time?

Attend if you would like to learn how to use simply one assay to monitor proteins from multiple sources

E.g.:

  • Viral vector proteins
  • Transgene proteins
  • Producer cell line (or packaging cell, or host cell)
  • Process related proteins; growth medium proteins (e.g. bovine serum, human albumin); cell culture adhesion (e.g. laminin, collagen); enzymes used in the manufacturing process (e.g. benzonase)

It’s free and only takes 30 minutes of your time.

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