About us

Impurity analysis & analytical characterization of biologics

Alphalyse is a CRO and protein analysis lab that helps accelerate drug development through impurity analysis and analytical protein characterization services based on mass spectrometry.

Our expertise lies in our ability to quickly understand the specific needs of our clientR...

Alphalyse is a CRO and protein analysis lab that helps accelerate drug development through impurity analysis and analytical protein characterization services based on mass spectrometry.

Our expertise lies in our ability to quickly understand the specific needs of our client’s therapy and the challenges that its manufacture presents and to tailor our services to meet these needs. You should see us as an extension of your lab and know that we take pride in building strong and rewarding relationships. We are as passionate about helping to develop a safe and effective therapy as you are.

Our lab and offices in Denmark and the USA help clients analyze protein-related impurities or verify protein analysis results for a wide variety of biologics, such as mAbs, vaccines, recombinant proteins, and CGTs. Typical clients include pharma, biotech, or research companies in the clinical development of biologics and cell and gene therapies for treating rare diseases.

After 20 years in business, we understand that many drug developers perceive mass spectrometry as complex. At Alphalyse, you can count on our team of experts focusing on making the results accessible for you to understand and use. We continually develop new and improve on the existing test methods. Our collaboration with top protein researchers and industry leaders in mass spectrometry equipment gives us the unique opportunity to implement the latest research within the field. 

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What to expect
What to expect?
Thomas Kofoed, CEO at Alphalyse

Essential partnerships and competencies

We partner with several companies that research enzymes and mass spec instruments, such as Genovis, Sciex, and Bruker. In this way, we ensure our access to the newest technology and that our research is targeted at real customer needs.

Many of our scientists are PhD graduates from the Protein Research Group at the University of Southern Denmark, renowned for its research work on mass spectrometry. Our team has experience with most kinds of biologics and can help you address various problems.

Being a small organization means we are agile and flexible and can quickly adjust to your specific demands.

Over the years, we have achieved a high customer satisfaction rating. As a result, our customers refer many new customers to us. We are incredibly proud that our customers are happy to recommend us, and for their loyalty!

Why rely on us

  • Certainty: As a CRO, protein analysis service is our core business. We understand that complete confidence in your product quality & integrity is crucial.
  • Capability: LC-MS can give a more profound perspective to anticipate potential consequences of residual proteins. We help find the right solution to your analytical challenges from project kick-off to final report.
  • Progress: As a progressive company adopting new technologies, we can create the competitive advantages you need to succeed.

Need more info?

You can visit these pages to learn about our journey or how to reach us.

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