Every vaccine contains small quantities of proteins. However, currently there is no analysis method capable of identifying and measuring the different protein residues. Therefore, the Danish Innovation Fund now invests six million Danish kroner in the development of a new effective LC-MS/MS analysis method for mapping residual proteins.
The vast majority of vaccines developed today are produced in genetically modified non-human cells (host cells). When you take a vaccine from the host cell, undesirable protein residues are inevitable. In some cases, they can affect our biology, and therefore, it is important to know which protein residues that may be present and in what quantities.
Head of Department Ingrid Kromann from Vaccine Development at Statens Serum Institut explains:
– Even after thorough purification steps it is not possible to remove all host cell proteins 100%. It is essential to have access to analytical methods which can identify and accurately quantify the present host cell proteins. You need this valuable information in both the development of new vaccines and in the quality control of existing vaccines.
Alphalyse is one of the only companies in the world capable of analysing Host Cell Proteins by LC-MS/MS analysis
The company Alphalyse, located in Odense, will develop the required analytical methods in close cooperation with the Protein Research Group at the University of Southern Denmark (SDU). Since 2002 Alphalyse has provided advanced protein analysis as a service to pharmaceutical and biotech companies worldwide. However, currently it is only possible to find a few host cell proteins at a time, and only if you know what you’re looking for.
– Due to the authorities’ increased requirements, all major vaccine manufacturers have begun to demand identification and accurate quantification of host cell proteins in vaccine samples. Today, Alphalyse is one of the only companies able to do this, and only with a few selected host cell proteins. There is still a long way to meet the actual need for identifying and measuring several hundred individual host cell proteins in these very low concentrations, says co-founder and technical director at Alphalyse Ejvind Mørtz.
Close business collaboration with the international leader in proteomics
The Protein Research Group at SDU is among the founders of mass spectrometry for protein characterization. For more than 25 years it has been the international leader within the field of proteomics. Professor Peter Højrup SDU says:
– We look forward to expand the limits for how complex protein mixtures can be analyzed with advanced LC-MS/MS. We therefore contribute with an extensive experience in protein analysis. Including access to Scandinavia’s largest collection of high-tech equipment for combined liquid chromatography and mass spectrometry.
– The establishment of this project is a successful example of SDU’s efforts with business collaboration. It provides a great opportunity to create more research jobs in Odense. We will work hard to achieve the ambitious goals of innovation and growth, says PhD Marie Grimstrup. For the coming 3 years she is seconded by TEK Innovation at SDU as a project manager for Alphalyse.
Alphalyse A/S, DK-5220 Odense SØ, COO Ejvind Mørtz, tel 40285010
Statens Serum Institut, 2300 Copenhagen S, Department Manager Ingrid Kromann, tel 22243873
University of Southern Denmark, DK-5230 Odense M, Professor Peter Højrup, tel 60112371
Budget: 11 million kroner
Foundation’s investment 6 million kroner
Duration: 3 years
Project title: Advanced LC-MS/MS analysis to provide even safer vaccines