Our approach

Alphalyse has pioneered the use of mass spectrometry analysis since 2002. Our scientists have completed over 10,000 protein characterization analyses, including forced degradation studies and more than 500 LC-MS-based residual/host cell protein projects.

As a specialist contract research organization (CRO), we offer protein analysis services to support biopharmaceutical companies in developing and manufacturing patient-safe products such as mAbs, vaccines, recombinant proteins, and cell & gene therapies.

You can count on us to work closely with you on developing well-characterized biologics by challenging and improving analysis methods using top-of-the-line mass spectrometry technology (LC-MS). Our comprehensive reports will allow you to carry out data-driven process development and regulatory documentation under ICH Q6B guidelines.

What sets us apart

Personal guidance from planning to execution and follow-up

We aim to become an extension of your team and take pride in building strong and rewarding relationships. We are as passionate about helping to develop a safe and effective therapy as you are.

Experts on HCP analysis
Knowledge on mass spectrometry

Expert knowledge and top-of-the-line technology

Our project leaders are PhD graduates, and many came the University of Southern Denmark, renowned for its research on mass spectrometry. We partner with leading instrument companies to ensure that we have access to the newest technology.

Experience with most types of biologics

We continue to advance and refine our techniques based on an ever-growing range of client projects across expression systems and molecules. To date, we have performed more than 5,000 characterization analyses for more than 500 clients worldwide.

Trusted-LC-MS-Expertise
an-agile-organization-blue

An agile organization that can quickly adjust to your specific needs

Are you working to solve a unique challenge? Our team can help you address a wide variety of problems related to drug development. All of our services were developed and improved upon in cooperation with clients – and we would be excited to help you too.

What sets us apart

Personal guidance from planning to execution and follow-up

We aim to become an extension of your team and take pride in building strong and rewarding relationships. We are as passionate about helping to develop a safe and effective therapy as you are.

Experts on HCP analysis
Knowledge on mass spectrometry

Expert knowledge and top-of-the-line technology

Our project leaders are PhD graduates, and many came the University of Southern Denmark, renowned for its research on mass spectrometry. We partner with leading instrument companies to ensure that we have access to the newest technology.

Experience with most types of biologics

We continue to advance and refine our techniques based on an ever-growing range of client projects across expression systems and molecules. To date, we have performed more than 5,000 characterization analyses for more than 500 clients worldwide.

SWATH LC-MS analysis
an-agile-organization-blue

An agile organization that can quickly adjust to your specific needs

Are you working to solve a unique challenge? Our team can help you address a wide variety of problems related to drug development. All of our services were developed and improved upon in cooperation with clients – and we would be excited to help you too.

Why rely on us

Certainty

We understand that complete confidence in your product quality and integrity is crucial. Protein analysis service is our core business, and we can help you unlock the knowledge necessary to move your project forward confidently and quickly.

Capability

LC-MS can give a more profound perspective to anticipate the 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 leading-edge company using top-of-the-line technologies, we can create the competitive advantages you need to succeed.

How we work

We customize every project to fit our client’s specific needs.

In collaboration with you, we will:

  • facilitate-blue

    Facilitate meetings to review the project scope and finalize the project proposal

  • appoint-(assign)-blue

    Appoint an experienced, PhD level project leader to your project to ensure timely delivery, fulfill the project objectives, and keep your team updated on progress

  • benefit-from-trusted-lc-ms-technology-blue

    Provide reproducible data using advanced instruments and robust workflows, with SOPs in place for all processes to ensure the highest quality

  • follow-up-blue

    Follow up the report with an online meeting to review the results and answer your questions

News and inspiration

HCP database

Webinar: Exclusive preview of the Alphalyse HCP database

Get an exclusive view of how you can use HCP-MS data from our 500 client projects
Identifying a polysorbate-degrading lipase in mAbs

Identifying a polysorbate-degrading lipase in mAbs

Lipases co-purifying with mAb products can degrade polysorbate even at trace levels
Hightlights from the 2024 BEBPA HCP Conference.

Highlights from the 2024 BEBPA HCP Conference

What's new? The latest on HCP analysis by MS from the 2024 BEBPA HCP Conference.
Case-24: Polysorbate degradation caused by LPL (lipoprotein lipase)

Video: What is causing polysorbate degradation?

When LPL affects the efficacy and safety of your drug product
Senior CMC managers Søren Skov Jensen and Margarita Sabater from Genmab

Webinars: Genmab’s Holistic HCP Control Strategy for mAbs

Genmab will present how to select the most appropriate release testing method
CDMO could not identify the cause of unstable mAb product

Video: Can your CDMO tackle Host Cell Proteins?

A mAb drug showed poor stability over time and the CDMO could not identify the cause

Talk to us

Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.

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