LC-MS/MS for accurate residual HCP analysis

Collaboration with: Statens Serum Institute (Denmark), SDU – University of Southern Denmark
Funded by: Innovation Fund Denmark
Time period: 2014-2017

Since 2014, Alphalyse has lead a consortium developing groundbreaking Host Cell Protein analysis using mass spectrometry. Together, we have investigated and developed novel SWATH LC-MS/MS methods. Thus, we now offer these methods for residual protein analysis of vaccine samples. – Even down to a low ppm-level.

The consortium is a close collaboration; Professor Peter Højrup from The Protein Research Group at SDU provided expertise in protein analysis by LC-MS/MS. Statens Serum Institute has provided vaccine samples for the analysis and expertise in current ELISA-based methods for HCP quantification.

Method published in 2016

Eventually, Alphalyse presented our newest analysis methods to identify and quantify process-related residual protein by LC-MS/MS at the world-leading HCP conference arranged by BEBPA* in May 2016, Lisbon, and in May 2017, San Francisco. Results are also described in our application note “Host Cell Protein Analysis of Downstream Process Samples by SWATH LC-MS/MS.”

*BEBPA: Biopharmaceutical emerging Best Practices Association

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