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Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product
Author(s) -
GasoSokac Dajana,
Kovac Spomenka,
Clifton James,
Josic Djuro
Publication year - 2011
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.201000641
Subject(s) - proteomics , quality by design , computer science , human plasma , posttranslational modification , biochemical engineering , computational biology , chemistry , chromatography , engineering , biology , biochemistry , enzyme , gene , particle size
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.