Eurostars Project E!10980 SaferBIOPHARMA. Safer biopharmaceuticals by improved monitoring of host cell protein impurities

Purpose and goal

The goal of the project was to increase knowledge on the use of mass spectrometry for measurement of host cell proteins in biopharmaceutical products, and to participate in development of new improved mass spectrometry methods. The task of Hansa Biopharma in this project was to bring the manufacturer’s point of view to the experimental setup, and provide materials and process specific reagents needed to test different mass spectrometry based analysis methods.

Expected results and effects

The main advantage of this project has been the increased knowledge and knowhow about analysis of host cell proteins which will help Hansa Biopharma in future process development. All project partners have gained increased knowledge on the analysis methods used for host cell protein analysis and the specific features of mass spectrometry based methods in particular. The project was performed according to plans. Hansa Biopharma is going to use the learnings of the methodology tested in this project in future manufacturing projects.

Planned approach and implementation

The main applicant and main project leader of this Eurostars project was the danish analytical company Alphalyse A/S who are specialists in mass spectrometric analyses of biopharmaceuticals. Syddansk Universitet was the academic collaborator developing methods for immunocapture combined with mass spectrometry. Hansa Biopharma’s main tasks were to provide the project partners with information on relevant experimental setups, and to lead the manufacturing and preparation of process samples and reagents used in the analysis testing at Alphalyse and Syddansk Universitet.