History of Alphalyse

How we got here

Alphalyse was founded in 2002 as a subsidiary of ACE Biosciences, Denmark, and soon expanded with facilities in California, USA.

In the beginning, Alphalyse primarily assisted ACE with analysis for their protein target discovery in infectious microorganisms and the development of protein-based vaccines and monoclonal antibodies, including investigation of host cell proteins (HCPs). Therefore, we soon discovered that by using mass spectrometry analysis, not only could we avoid using the classical and tiresome method of straining and cutting gels. – We could also produce quantitative data. Thus, we set out on a journey to investigate and develop mass-spectrometry-based host cell protein analysis.

Development of the Alphalyse service concept

By 2005 Thomas Kofoed and Ejvind Mørtz took over Alphalyse in a management buy-out and soon began to expand the company’s services worldwide.

Early on, the ambition was to provide research laboratories worldwide with a fast, affordable, and convenient way of outsourcing their protein analysis. By popular demand, the portfolio evolved to include a large number of analysis options. However, our friendly and professional attitude and our easy-to-understand reports remain one of the backbones of our success.

Moving into customization and development of HCP analysis

Alphalyse soon realized that our expertise lies in 1) Our ability to understand and deliver on our customers’ individual needs and 2) Our unique knowledge and use of mass spectrometry for analyzing proteins and protein impurities. Thus, our ties to top protein researchers in Denmark put us in a unique position for implementing the newest research into our test methods.

We now offer several customized analyses used in the advanced characterization of biopharmaceuticals, including Host Cell Proteins (HCP) analysis. In early 2014, we received a 3-year grant for further development of HCP analysis, taking our expertise to new grounds, followed by two additional grants in 2016 for the development of HCP analysis. Today, we are leading in analyzing HCPs using mass spectrometry, having used the method on 300+ customer problems. Since March 2022, we are offering the HCP analysis under GMP conditions – as the first laboratory in the World.

Today, Alphalyse has thousands of customers all over the world. We pride ourselves on quickly and conveniently supplying unique solutions to our CMC clients in Pharma and Biotech through our offices in the USA and Denmark.

Follow this link to explore who we are and what we offer as a CRO.

Key milestones:

  • 2022 – Alphalyse reaches 300 customer host cell protein analysis projects
  • 2022 – As the first commercial laboratory in the world, we received approval for GMP-validated HCP analysis
  • 2021 – Alphalyse reaches 200 customer host cell protein analysis projects
  • 2021 – Alphalyse is again recognized by BDO as Successful Enterprise of the Year – for the third year in a row
  • 2020 – Alphalyse moves headquarters to new premises close to the University of Southern Denmark
  • 2020 – We reach 100 customer host cell protein analysis projects
  • 2019 – Alphalyse wins a special prize for Best Digital Transformation
  • 2019 – We are again at the forefront of technology, as we introduce ELISA-MS, Coverage Analysis based on MS
  • 2018 – Alphalyse reaches the first 40 customer HCP projects – thus becoming the world’s most experienced HCP MS-lab
  • 2016 – 2 grants for the development of methods to provide Safer biopharmaceuticals through validated HCP analysis and improved HCP analysis
  • 2016 – Alphalyse receives 2nd place in DK Ecommerce Awards 2016 – Best cross-border company
  • 2014 – Grant for development of new improved analysis of HCP by mass spectrometry
  • 2011 – Alphalyse opens the world’s first webshop for Protein Analysis Services
  • 2010 – Announced as one of the fastest-growing companies in the region (Borsen Gazelle)
  • 2009 – Implementation of SOP system for quality control
  • 2008 – Establishment of Alphalyse Inc, Palo Alto, CA,  USA
  • 2006 – Introduction of the PICK ‘n POST™ service concept
  • 2005 – Management buy-out
  • 2002 – Incorporation in Denmark

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