Our research

Alphalyse is the world's leading expert in host cell protein analysis by mass spectrometry. We have been at the forefront of protein analysis research for over two decades - science comes first in everything we do.

Our goal is to support the development of superior biologics through better analytics. Our research on drug product characterization and protein impurity analysis by mass spectrometry provides biopharmaceutical developers with a comprehensive understanding of their therapeutics, improving drug quality and patient safety.

Research and collaboration partners

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Collaborations with clients

Alphalyse is a global leader in protein analysis by mass spectrometry. Our research focuses on solving pressing analytical challenges in the biopharmaceutical industry.

By prioritizing client collaborations, we ensure that our research meets real-world needs. Our work spans therapeutic protein characterization, impurity identification and quantification, and HCP coverage analysis, to support drug development processes and improve therapeutic outcomes.

Our client collaborations have resulted in the world's first GMP-compliant MS-based HCP analysis for release testing.

Client collaboration is essential at Alphalyse
Research at Alphalyse

EU and DK funded innovation

Since 2014, Alphalyse has received €1.4M in funding from Innovation Fund Denmark, the Market Development Fund, and Eurostars for development of novel HCP analysis by mass spectrometry, methods for validation, and high-throughput antibody characterization.

These projects have been conducted in collaboration with the Protein Research Group at the University of Southern Denmark,  and biotherapeutics developers in Europe and the USA.

Non-profit organization partnerships

Alphalyse is proud to collaborate with several non-profit organizations, including the US Pharmacopeia, the Biopharmaceutical Emerging Best Practices Association (BEBPA), and Life Science Fyn.

These collaborations provide platforms for Alphalyse to share research results and contribute insights in support of broader efforts to improve drug product quality, efficacy, safety, and overall industry standards for the benefit of patients and the biopharmaceutical community.

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University of Southern Denmark

Academic research

Alphalyse has a long-standing tradition of working with leading university institutions to bridge the gap between cutting-edge academic research and real-world industry applications.

Together with the University of Southern Denmark, Alphalyse offers student internships, BSc and MSc thesis projects, and PhD programs that give researchers and students hands-on experience with advanced protein analysis techniques, drive scientific breakthroughs, and educate the next generation of proteomics experts.

Scientific contributions

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Peer-reviewed articles

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Editorials

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Client patents

First in the world

Press release: World's first MS-based HCP analysis release test under GMP

FDA approval of World's first IND with only LC-MS-based HCP data

Publication: World's first LC-MS-based HCP analysis

20 years of innovation

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Our protein analysis research

Since 2002, Alphalyse has been a pioneer in advanced protein analytics, continuously refining techniques and developing innovative methods to meet the evolving needs of the biopharmaceutical industry.

Our research has contributed to shaping mass spectrometry-based analysis of biologics and residual impurities. Find our most referenced publications below.

Paper: HCP Coverage by Immunocapture and LC-MS/MS

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Poster: Sensitive MS-assay for detecting polysorbate-degrading HCPs in mAbs

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Paper: Monitoring process-related impurities in biologics - HCP analysis

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Poster: ID & quantify individual HCPs using SWATH® LC-MS

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Protocol: Silver staining of gels optimized for LC-MS protein identification

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The Alphalyse HCP database

We have access to our own unique database containing information on all HCPs we have identified in client samples of recombinant
proteins, mAbs, vaccines, and gene therapy products, from every stage of development and manufacturing.

HCP
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Total HCPs

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Unique HCPs

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Total ions

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Total peptides

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Unique samples

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Organisms

Peer-reviewed papers with data from Alphalyse

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.