Public funding to improve the safety of biopharmaceuticals

Alphalyse has received a large grant for developing a method to identify and quantify the host cell proteins (HCP) in a drug sample. The project takes place in close cooperation with the Swedish biopharmaceutical company Hansa Medical and University of Southern Denmark (SDU). In collaboration we will develop new strategies for host cell protein analysis – by providing a measure of ELISA coverage for HCP for better ELISA assay validation.

It is a well-known fact that HCP impurities in biopharmaceuticals can cause severe side effects. Only by identifying such high-risk host cell proteins, will it be possible for manufacturers to deliberately remove these; hereby avoiding their possible side effects.

Existing ELISA methods only measure 30-70% of the host cell protein impurities

According to Ejvind Mørtz, COO at Alphalyse, it is a severe flaw of today´s golden method for identifying HCP impurities, ELISA, that it only quantifies 30-70% of the host cell proteins present in a drug sample. In addition, the exact identity of those is completely unknown. This provides some degree of risk for patients, as manufacturers have very limited knowledge about the host cell impurities of their drug and their possible effects on the patient.

Alphalyse already developed a new HCP analysis method, based on mass spectrometry, which can identify even very small amounts of host cell protein in a drug sample. Through the new project Alphalyse, Hansa Medical and SDU seek to combine mass spectrometry and immunoaffinity purification to give a measure of ELISA coverage. Through this combination the consortium will develop a method to select the ELISA with the best coverage for a given process sample.

“Our innovative idea is to take the drug sample and identify exactly which host cell proteins are recognized by a given ELISA, and which host cell proteins are not recognized by this ELISA,” explains Ejvind Mørtz.  “We will be able to perform a detailed analysis of a range of ELISA assays. Eventually, we can suggest a selection of 2-3 ELISA assays best capable of quantifying all important HCPs.”

Funding by 3 public agencies in EU, Denmark and Sweden

Due to its huge potential, the project has been awarded funding by the EUROSTARS program. During the next 2½ years, the project’s 3 partners will receive a total of $800.000/€750.000. The funding comes from the EU and the Danish and Swedish Ministries for Science.

Concurrently with this new project, Alphalyse is also working on two other projects with funding from the Danish Ministry. Both of these projects involve identification and quantification of HCP impurities in biopharmaceuticals.

For more information on our host cell protein analysis services, please contact Ejvind Mørtz