title: Therapeutic plasma proteins--application of proteomics in process optimization, validation, and analysis of the final product.
abstract: An overview is given on the application of proteomic technology in the monitoring of different steps during the production of therapeutic proteins from human plasma. Recent advances in this technology enable the use of proteomics as an advantageous tool for the validation of already existing processes, the development and fine tuning of new production steps, the characterization and quality control of final products, the detection of both harmful impurities and modifications of the therapeutic protein and the auditing of batch-to-batch variations. Further, use of proteomics for preclinical testing of new products, which can be either recombinant or plasma-derived, is also discussed.
authors.affiliation: Department of Chemistry, J. J. Strossmayer Univeristy, Osijek, Croatia.
authors.forename: Dajana
authors.initials: D
authors.lastname: Gaso-Sokac
authors.forename: Spomenka
authors.initials: S
authors.lastname: Kovac
authors.forename: James
authors.initials: J
authors.lastname: Clifton
authors.forename: Djuro
authors.initials: D
authors.lastname: Josic
mesh_terms: D001798:Blood Proteins / Q000096:biosynthesis / Q000737:chemistry* / Q000302:isolation & purification / Q000627:therapeutic use*; D006801:Humans; D040901:Proteomics / Q000379:methods*; D011786:Quality Control; D015203:Reproducibility of Results
chemical_list: D001798:Blood Proteins