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 industry measures residual host cell proteins (HCP) in biopharmaceuticals. The outcome should be a validated HCP quantification 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.

Through this project, we will refine the HCP analysis method by SWATH LC-MS/MS. 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 in accordance to regulatory guidelines, together with different test customers.

A validated HCP quantification 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 quantification at the BEBPA congress in San Francisco.

View press release

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