Validation of LC-MS for HCP analysis

Collaboration with: Savara Inc (USA) / Savara ApS (Denmark) and Affibody AB (Sweden)
Funded by: The Market Development Fund
Time period: 2016-2018

Through this project, we aim at changing the way the industry measures residual HCP levels in biopharmaceuticals. The outcome should be a validated residual HCP quantitation method by SWATH LC-MS/MS. This will make it faster to bring new biopharmaceutical products to the market. And eventually, also make the biopharmaceuticals safer to use.

Currently, biopharmaceutical companies all over the world make use of validated ELISA assays. These assays monitor the total content of host cell proteins (HCPs) present in their final protein drug product. However, you do not get any details about the identity or quantity of the process-specific HCP.

Development of SWATH mass spectrometry hcp analysis

Through this project, we will refine the HCP analysis method by SWATH mass spectrometry. We developed this method in collaboration with the University of Southern Denmark (SDU) and Statens Serum Institut, in a previous collaboration supported by Innovation Fund Denmark. The project includes method qualification and validation per regulatory guidelines, together with different test customers.

A validated residual HCP quantitation method by SWATH LC-MS/MS will thus make it faster and safer to bring new biopharmaceutical products to the market.

In 2017 we made a joint presentation with Savara on HCP quantitation at the BEBPA HCP meeting in San Francisco.

View press release

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