Our story and values
Alphalyse started with a simple yet ambitious dream: to revolutionize protein analysis using mass spectrometry. When we began our journey in 2002, we were a small startup with big ideas. Today, we are proud to be recognized as a global leader in advanced protein analysis services.
From our humble beginnings to our current position as a trusted partner to some of the world’s leading biopharmaceutical companies, we are proud of our history and remain committed to advancing the field of protein analysis – one breakthrough at a time.
Who we are
A vision of creating superior biologics through better analytics
Our story started in 2002 when co-founders Thomas Kofoed and Ejvind Mørtz recognized the need for more precise, reliable, and comprehensive protein characterization techniques for biopharmaceutical drug development.
Using mass spectrometry analysis, they found it possible to avoid the traditional and tiresome method of staining and cutting gels while still producing quantitative data. This pivotal moment marked the beginning of our journey to investigate and develop mass spectrometry-based protein impurity analyses.
We knew there had to be a better way to perform protein analysis and that mass spectrometry was the key.
But when we started, nobody knew if it was possible to make LC-MS analysis robust and reproducible enough for GMP validation.
We wanted to find out. And we did! Today, we're still the only CRO in the world who can do it.
– Thomas Kofoed, CEO.
First and only in the world
Driven by their passion for innovative approaches to protein analysis, Thomas and Ejvind now lead a team of 35 proteomics experts specializing in mass spectrometry analysis.
By combining pioneering research and cutting-edge technology, Alphalyse has developed the industry's most robust and reproducible mass spectrometry-based protein impurity analysis. To date, the method has been used on 550+ client projects.
Since March 2022, we have also offered our Host Cell Protein analysis under Good Manufacturing Practice (GMP) conditions – as the first and only laboratory in the world capable of this.
With our clients, for our clients
At Alphalyse, we employ a collaborative approach, forging strong partnerships with biopharmaceutical clients and academic institutions to develop and improve our methods.
From the very beginning, our research has been guided by the needs of the biopharmaceutical industry. All advancements of our analytical capabilities have targeted real-world challenges, enabling us to provide the innovative solutions our clients require.
We aim to become a part of our clients' team, offering personal guidance from planning to execution and adapting our analytical methods to the unique requirements of each project we join.
The history of Alphalyse
2024
Alphalyse successfully completed 500 client Host Cell Protein projects, cementing our position as the most experienced HCP MS lab in the world.
2023
Alphalyse implemented a GMO lab, enhancing our ability to handle genetically modified organisms and expanding our analytical capabilities.
400 client HCP projects completed.
Winner of the BDO Successful Enterprise Award for the
5th year in a row and nominated for the EY Entrepreneur
Of The Year award.
2022
Alphalyse became the first commercial laboratory in the world to receive approval for GMP-validated HCP analysis.
Subsequently, we performed the world’s first GMP-certified mass spectrometry-based HCP analysis for product release testing for Phase 3 clinical trial.
2021
For the first time, the FDA approved an Investigational New Drug (IND) application using only LC-MS-based Host Cell Protein (HCP). The data was supplied by Alphalyse.
In 2021, Alphalyse also completed our 200th client
HCP project.
2020
Alphalyse headquarters were relocated to new premises near the University of Southern Denmark.
We maintain a close collaborative relationship with the university's Department of Biochemistry and Molecular Biomedicine, offering student internships, bachelor's and master's thesis projects, and PhD programs.
2019
Alphalyse developed and introduced ELISA-MS™, an innovative coverage analysis combining ELISA-based immunocapture with precise protein identification by MS.
Unlike other methods, ELISA-MS™ analysis utilizes immunocapture directly in the ELISA well and measures the actual protein-antibody binding without artificial systems.
The method evaluates the effectiveness of HCP ELISA antibodies under actual assay conditions.
2018
Alphalyse successfully completed 40 client Host Cell Protein projects, making Alphalyse the world’s most experienced HCP MS-lab.
2016
Alphalyse was awarded a 2 million DKK grant by the Danish Market Development Fund to develop methods to provide safer biopharmaceuticals through validated HCP analysis and improved HCP analysis by LC-MS in collaboration with two international clients.
2014
The Innovation Fund Denmark awarded Alphalyse 6 million DKK to develop a new method for analyzing HCP by mass spectrometry in collaboration with the Protein Research Group at the University of Southern Denmark.
The Protein Research Group at SDU is among the founders of mass spectrometry for protein characterization. For more than 40 years, it has been the international leader in proteomics research.
2009
In 2009, Alphalyse implemented a Standard Operating Procedure (SOP) system for quality control to ensure the highest standards of quality and consistency.
2008
In 2008, Alphalyse expanded its global footprint by establishing Alphalyse Inc. in Palo Alto, California, USA.
This allowed Alphalyse to serve better the burgeoning biotechnology and pharmaceutical industries in North America, facilitating closer collaboration with leading biotech companies and academic institutions in Silicon Valley and beyond.
In 2008, Alphalyse also released the first scientific publication on using LC-MS for HCP analysis. This groundbreaking work demonstrated the potential of LC-MS to revolutionize HCP detection, identification, and quantification.
2005
Thomas Kofoed and Ejvind Mørtz took over Alphalyse in a management buy-out and expanded the company's services worldwide, specializing in customized analyses for the advanced characterization of biopharmaceuticals, including HCP analysis.
2002
Alphalyse was founded as a subsidiary of ACE Biosciences, Denmark, to analyze proteins in infectious microorganisms, develop protein-based vaccines and monoclonal antibodies, and investigate Host Cell Proteins (HCPs).
The history of Alphalyse
2024
GMO lab implemented
400 client HCP projects completed
Winner of BDO Successful Enterprise Award for the
5th year in a row and nominated for YE of the year
2023
GMO lab implemented
400 client HCP projects completed
Winner of BDO Successful Enterprise Award for the
5th year in a row and nominated for YE of the year
2022
First GMP release test for Phase 3 trials using only LS-MS-based HCP data
The first commercial laboratory in the world to receive approval for GMP-validated HCP analysis
300 client HCP projects completed
Winner of BDO Successful Enterprise Award for the
4th year in a row
2021
First Investigational New Drug (IND) application using only LS-MS-based HCP data approved by the FDA
200 client HCP projects completed
2020
Headquarters moved to new premises close to the University of Southern Denmark
100 client HCP projects completed
2019
Introducing ELISA-MSTM, coverage analysis
based on MS
2018
Eurostars grant for improving cancer drugs based on
antibody drug conjugates
2016
Market Development Fund grant for the development
of methods to provide safer biopharmaceuticals
through validated HCP analysis and improved
HCP analysis by LC-MS
2014
Innovation Fund Denmark grant for developing new,
improved analysis of HCP by mass spectrometry
2009
Implementation of SOP system for quality control
2008
Establishment of Alphalyse Inc, Palo Alto, CA, USA
First scientific publication on using LC-MS for
HCP analysis
2005
Thomas Kofoed and Ejvind Mørtz take
over Alphalyse in a management buy-out
2002
Incorporation in Denmark
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.