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.

Thomas Kofoed and Ejvind Mørtz

The history of Alphalyse

2022

CRO laboratory

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

LC-MS-based analysis of host cell proteins

2020

Alphalyse CRO in Denmark

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

Protein analysis

2018

Scientist using TTOF 6600 from Sciex

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

HCP ELISA analysis

2014

COVID19 vaccine

Innovation Fund Denmark grant for developing new,
improved analysis of HCP by mass spectrometry

Implementation of SOP system for quality control

2009

Scientists using automated digestion robot

2008

Custom solutions

Establishment of Alphalyse Inc, Palo Alto, CA,  USA

First scientific publication on using LC-MS for
HCP analysis

Incorporation in Denmark

2002

testing elisa standards

The history of Alphalyse

CRO laboratory

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

LC-MS-based analysis of host cell proteins

2021

First Investigational New Drug (IND) application using only LS-MS-based HCP data approved by the FDA

200 client  HCP projects completed

Alphalyse CRO in Denmark

2020

Headquarters moved to new premises close to the University of Southern Denmark

100 client HCP projects completed

Protein analysis

2019

Introducing ELISA-MSTM, coverage analysis
based on MS

Scientist using TTOF 6600 from Sciex

2018

Eurostars grant for improving cancer drugs based on
antibody drug conjugates

HCP ELISA analysis

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

COVID19 vaccine

2014

Innovation Fund Denmark grant for developing new,
improved analysis of HCP by mass spectrometry

Scientists using automated digestion robot

2009

Implementation of SOP system for quality control

_3AT2483

2008

Establishment of Alphalyse Inc, Palo Alto, CA,  USA

First scientific publication on using LC-MS for
HCP analysis

testing elisa standards

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.

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