Alphalyse has received a large grant, which we will use to test and validate our newly developed LC-MS/MS methods for Host Cell Protein (HCP) analysis. The testing takes place in close collaboration with two biotech companies from America and Sweden.
The collaboration seeks to change the way the industry measures HCP in biopharmaceuticals. We aim for a HCP assay validation test method, for making it both faster and safer to bring new products to market.
The grant, awarded by The Danish Market Development Fund, amounts to 2 mio. DKK ($290.000/€270.000). This covers approx. 35% of the total project budget of $900.000/€800.000.
LC-MS/MS methods for identification and quantification of individual HCPs in vaccine samples
Today, biopharmaceutical companies all over the world use validated ELISA assays to monitor the total content of Host Cell Proteins (HCPs) present in their protein drug samples. However, ELISA only provides information about the total content of host cell proteins. It provides no information about the identity or quantity of individual host cell proteins.
Since 2014, Alphalyse has been leading a consortium developing groundbreaking HCP analysis using mass spectrometry. The consortium includes the University of Southern Denmark and Statens Serum Institute, and receives financial support by Innovation Fund Denmark. Together, we have developed novel LC-MS/MS methods for identification and quantification of individual host cell proteins in vaccine samples to low ppm level. With the new grant we will further develop these methods, including testing and validation in accordance with regulatory guidelines.
“We are convinced that through this testing and validation, we will increase the market for host cell protein assays using mass spectrometry with several orders of magnitude”, says COO Ejvind Mortz. “Customers can already order our novel analysis service for research and development purposes. However, many customers also need a validated analysis method, but don’t dare to go the mass spec way just yet. They await to see that the method can be validated to fulfill the requirements set by legal authorities.”