Our story
Alphalyse was founded in 2002 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).
In 2005, Thomas Kofoed and Ejvind Mørtz took over Alphalyse in a management buy-out. They soon began to expand the company’s services worldwide, specializing in customized analyses for the advanced characterization of biopharmaceuticals, including HCP analysis.
The start of Alphalyse
Thomas and Ejvind discovered that by using mass spectrometry analysis, it is possible to avoid using the traditional and tiresome method of staining and cutting gels while still producing quantitative data. This was the start of Alphalyse’s journey to investigate and develop mass-spectrometry-based HCP analysis.
Today, we are world leaders in analyzing HCPs using mass spectrometry, having used the method on 400+ client projects. Since March 2022, we have offered the HCP analysis under GMP conditions – as the first laboratory in the world to do this.
The history of Alphalyse
2022
First 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
First Investigational New Drug (IND) application using only LS-MS-based HCP data approved by the FDA
200 client HCP projects completed
2021
2020
Headquarters moved to new premises close to the
University of Southern Denmark
100 client HCP projects completed
Introducing ELISA-MS™, coverage analysis
based on MS
2019
2018
40 client HCP projects completed – making Alphalyse
the world’s most experienced HCP MS-lab
Market Development Fund grant for the development
of methods to provide safer biopharmaceuticals
through validated HCP analysis and improved
HCP analysis by LC-MS
2016
2014
Innovation Fund Denmark grant for developing new,
improved analysis of HCP by mass spectrometry
Implementation of SOP system for quality control
2009
2008
Establishment of Alphalyse Inc, Palo Alto, CA, USA
First scientific publication on using LC-MS for
HCP analysis
Incorporation in Denmark
2002
The history of Alphalyse
2022
First release test for Phase 3 trials using only LS-MSbased 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
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.