Process-related impurities 30 minute webinar on-demand

Analyzing vaccine purity
– without an HCP ELISA

Are you struggling to document that your downstream process consistently produces a safe product? In this webinar, you will learn how to quickly measure and compare residual protein in any type of vaccine.

For complex products like vaccines, it can be difficult to find an ELISA with sufficient coverage of process-related impurities.

However, there is a plan B: In this webinar, Ejvind Mortz shows how our clients quickly identify and quantify all proteins in any type of vaccine. The method measures viral protein as well as process-related impurities, such as Host Cell Protein – in less than 100 days.

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About this broadcast:

Do you recognize any of this?

Host cell protein analysis of gene therapies

  • You work on a vaccine, e.g., inactivated, live attenuated, subunit or conjugate, viral vector, toxoid, or VLP.
  • You have trouble finding an ELISA that covers the proteins in your vaccine.
  • The coverage of your HCP ELISA is lower than expected.
  • You wonder how to quantify specific process-related impurities – regardless of the source.

contact Alphalyse

If you answered yes to at least one of the above, you probably already know that …

the complexity of vaccines results in a broad population of process-related impurities from different sources. They may include viral proteins, host cell proteins, and growth mediums. You may even be utilizing a rare growth medium.

Due to the complexity, many CMC managers find it challenging to find a suitable commercial ELISA to document the impurities. Instead, they start developing a custom HCP ELISA, which is both expensive and time-consuming – and involves a risk of ending up with a custom ELISA with low coverage – and then you are back to square one.

Furthermore, the short development time for some products, like COVID-19 vaccines, does not allow for developing a process-specific ELISA.

Many vaccine developers thus turn to mass spectrometry analysis, as it is a safe and fast way to characterize and monitor process-related impurities in complex products.

protein analysis services

Why are process-related impurities a concern in vaccines?

Regulatory authorities like the FDA are increasingly aware of the impact protein impurities may have on patient safety and product stability. Especially for vaccines administered to an otherwise healthy population, including kids and the elderly.

Specific proteins, even in low quantities, may:

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

Thus, your vaccine should be well-characterized, and you should monitor the manufacturing consistency of specific proteins.

The good news is:

You only need one standardized assay to analyze proteins from multiple sources

Mass spectrometry (LC-MS) provides the identity and quantity – with high reproducibility – of each protein impurity in any vaccine.

In this webinar, you will see how a mass spectrometry assay for measuring impurities is

✅ Directly applicable – for a variety of vaccine types and cell lines

Generic – allowing comparison of protein profiles between products

Reproducible – enabling batch consistency in scale-up and CMO transfer

✅ GMP compliant – for method validation and release testing

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Ejvind Mortz, COO & Head of Innovation shows:

Ejvind Mørtz, Alphalyse talks on impurities in gene therapies

  • How to apply mass spectrometry to differentiate and identify all protein impurities – down to low ppm in concentration.
  • The basics of quantifying individual protein impurities
  • Several client stories and data from vaccines – including several COVID-19 examples – that applied mass spectrometry analysis.
Learn how to document impurities >>>
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Technology you can trust

You’re in safe hands with our LC-MS experts. Our clients have received data for 300+ HCP projects for vaccines, mAbs, therapeutic proteins, and cell and gene therapies.

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
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This webinar is a must-attend if you:

  • Are a CMC manager involved in the process of development of vaccines, including inactivated, live attenuated, subunit, polysaccharide and conjugate, viral vector, toxoid, and VLP vaccines.
  • Consult for a company that cannot find or develop a suitable HCP ELISA.
  • Under time constraints for developing a safe vaccine, e.g. for COVID-19.
contact Alphalyse

After participating, you will…

✅ Understand why mass spectrometry is a powerful method for analyzing protein in complex products.

✅ Be able to reference several examples of results from LC-MS analysis of vaccines.

✅ Know how to design a plan B if your HCP ELISA fails.

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– About the webinar –

When:

On-demand

 

It takes less than a minute to register:

Register for free today to attend from the comforts of your office or home, wherever you are!
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 devices (laptop, PC, phone) – without downloading anything.

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CRO Denmark

Still not sure if this webinar is worth your time?

Attend if you want to know how one generic assay can monitor proteins from multiple sources

E.g.:

  • Viral vector proteins (e.g., adenovirus, adeno-associated virus, lentivirus, retrovirus, baculovirus, herpes simplex virus, or bacteriophages)
  • 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)

The webinar is free and only takes 30 minutes – including a short Q&A session.

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