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It all starts with a conversation Tap into our experience from 300+ projects

Would you consider a free online consultation?

Many people still believe that MS analysis is complex, expensive, and challenging to set up. However, it does not have to be like that.

The team of experts at Alphalyse has experience from hundreds of projects using mass spectrometry to analyze impurities in biologics and cell & gene therapies. They can advise on how applying MS analysis to your project provides a complete picture of all proteins, making the technology easily accessible.

Curious to know more? Push the button below and fill in the form, and we will contact you to set up an online meeting.

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Talk with our experts

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Learn more:

  • About Alphalyse

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  • Cell & Gene Therapy Analysis

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Are you a CMC Manager or Lead Scientist in Analytical or Process Development?

Host cell protein analysis

Then you might be unsure of:

  • The exact content of your process and product samples?
  • The stability and structure of your biologic?
  • How to improve and reduce tiresome purification steps?

Or maybe you need a second look at your residual protein analysis?

contact Alphalyse

Book an online meeting with our CGT experts to get input for your project

After the meeting, you will have:

  • In-depth knowledge of how Mass Spectrometry complements ELISA
  • An overview of the services that will fit your project
  • The possibility of receiving a customized project description

What have others gained from working with us?

So far, we have completed 300+ successful Residual Protein projects based on Mass Spectrometry (MS)

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Proven technology you can trust

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

Hear what our clients say:

  • “We got a detailed host cell protein overview and targeted elimination of impurities without developing a process-specific ELISA.”
  • “We could compare and select the best-fitted ELISA assay, based on information of coverage of individual host cell proteins.”
  • “By supplementing our ELISA with Alphalyse’s analysis, we could document our anti-cancer drug’s key protein features, stability, and process-related impurity levels.”
  • “The results helped us optimize our process development, product quality, and process-related impurities. Overall, we have saved at least $1.000.000 on antibodies and one year on our drug development.”
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Will you benefit from a 60-minute session with our experts?

Our customers develop vaccines, therapeutic products, biosimilars, biopharmaceuticals, or consult for such companies.

Our experience shows that you get the best results when 3-4 persons from your organization join the meeting.

Depending on the project, you should invite the project manager and lead scientists from Analytical- or Process-Development.

Alphalyse - Eppendorf - protein preparation

Why rely on our expertise?

The Alphalyse lab is the most experienced in the World for host cell protein (HCP) analysis of biologics by Mass Spectrometry:

  • Our team of dedicated PhD-level experts spent five years developing and optimizing the host cell protein analysis in collaboration with leading experts in the field.
  • We apply the analysis to all process samples types and expression systems, including CHO, E. coli, yeast, etc.
  • To achieve robust results, we use the most advanced equipment on the market – and have completely automated the sample preparation.
  • We are well underway to receiving GMP certification for the analysis – making us the World’s first lab to bring LC-MS analysis to this quality level.
  • Recognized as an industry expert, the BEBPA organizers invited us to talk at their last four Host Cell Protein conferences.
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– All you invest is 1 hour of your time.

Our goal is that you should end up SAVING time – our customers speed up their process development and optimize impurity removal using mass spectrometry-based Host Cell Protein analysis.

Details:

Our experts can usually schedule a call with you and your team within a few days.
Before the meeting, we will contact you to clarify which parties you should involve at this early stage.

Depending on your preference, the meeting uses Microsoft Teams or WebEx.

Our experience shows that you get the best results when 3-4 relevant persons from your organization participate.

During the meeting, we typically cover:

  • A summary of how the LC-MS analysis works
  • An introduction to your projects and challenges
  • A discussion of how you can benefit from including mass spectrometry in your documentation

Still in doubt if you will benefit from an hour with our experts?

Consider this:

  • Do you want to avoid project delays?
  • Are you in a hurry and would like to skip the development of process-specific HCP-ELISA antibodies?
  • Would you like to intelligently remove host cell proteins based on information about the pI and MW of individual HCPs?

We would love to set up a meeting to learn about your project and advise how your benefit from mass spectrometry-based residual protein analysis.

Let’s get in touch

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