Alphalyse Proteomics Technology Applied in Process Development of a Protein Vaccine

Alphalyse protein analysis technology has been applied by ACE BioSciences in both upstream and downstream process development of a protein vaccine for clinical trials.

January 2008

Development of protein vaccines requires a range of protein assays in cell line selection, downstream protein purification and analytical characterization of the purified drug substance, as well as for regulatory documentation. Alphalyse proteomics technology has been applied successfully in the project for the selection of an optimal cell line, for improvement of the purification process, for identification of host cell proteins and product related variants, as well as for stability assays of the formulated drug product. The assays have been included in the PAT strategy for later-stage development of the protein vaccine, and the analytical results have been included in the CMC section of the Investigational Medicinal Product Dossier (IMPD) for clinical trials.

The results have been published in Bioprocess International 6, p36-43, 2008. “Proteomics technology applied to upstream and downstream process development of a protein vaccine”, by Mortz, E., Villsen, I, Boysen, A., Kofoed, T, and Skriver, L.

Alphalyse now offers protein manufacturing assays to assist biotech and CMO customers in development of protein biologicals, including natural and recombinant proteins and antibodies.

“Our protein manufacturing assays are unique in the way they enable a faster process development phase with better documentation of each step. Consequently this lowers the risk for project sidetracking and delays by regulatory actions later in the project “, says Ejvind Mørtz, COO of Alphalyse. “We are extremely happy that our protein assays have been well accepted by our customers and that they are now being used for clinical development of several protein biologics”.

For more information, please contact:
Ejvind Mørtz, COO +4563106500, or email mortz@alphalyse.com is a biotech company providing advanced protein analysis services to the life science community. The company provides through its Pick ‘n Post Protein Analysis services a range of unique high quality protein analysis that makes it possible to identify and characterize proteins to the highest level. Customers within Academia, Biotech, Pharmaceutical and Food industry get easy access to a world-class protein analysis laboratory without having to invest heavily in instruments, lab facilities and expertise. Alphalyse has offices in Odense, Denmark and Palo Alto, California, USA.

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