Thomas Kofoed, PhD
CEO and Co-founder of Alphalyse
With over 25 years of experience, Thomas Kofoed is a seasoned specialist in developing protein analyses and mass spectrometry methods for protein biologics development. He holds a PhD in Chemistry from the University of Southern Denmark and a degree in Business Administration.
He has been responsible for general management of Alphalyse since its inception in 2002. Previous positions include Head of Proteomics at ACE BioSciences, Associated Professor at Copenhagen University, and Senior Scientist at PNA Diagnostics.
Thomas has been a key driver in developing the industry's most robust and reproducible mass spectrometry-based protein impurity analysis method, which has recently been included in USP General Chapter 1132.1. He guided Alphalyse to become the first commercial laboratory in the world to receive approval for GMP-validated HCP analysis for release testing by the Danish Medicines Agency in 2022.
As a seasoned specialist on the topic of mass spectrometry and HCP analysis, Thomas has given invited talks at several industry meetings, including the BEBPA HCP conference in 2017, 2018, and 2021, ESAC in 2009 and 2017, MS-Öresund in 2011, the Bioprocessing Summit in 2023 and 2024, and many more.
Article: Regulatory Consequences of New Protein-Impurity Guidelines
Article: Is mass spectrometry the future of impurity analysis?
Poster: Sensitive MS-based lipase assay for mAb products
Blog: Why is reproducible mass spectrometry challenging?
Webinar: #Rethink your HCP strategy
Article: Monitoring process-related impurities in biologics
Webinar: Why do we need orthogonal HCP analysis for mAbs?
Webinar: Moving LC-MS analysis into a GMP environment
Webinar: Data-driven process development using HCP analysis by LC-MS
Webinar: The principles of mass spectrometry for HCP analysis
White paper: HCP analysis of downstream process samples by LC-MS
Blog post: Assessing and monitoring quality of therapeutic mAb products
Blog post: How to identify peaks observed by UV-HPLC in stability studies
Blog post: Why you need accurate concentration determination of protein standards
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