Naslov
Therapeutic plasma proteins – application of proteomics in process optimization, validation, and analysis of the final product

Autori
Gašo-Sokač, Dajana ; Kovač, Spomenka ; Clifton, James ; Josić, Đuro

Izvornik
Electrophoresis (0173-0835) 32 (2011), 10; 1104-1117

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, pregledni rad, znanstveni

Ključne riječi
plasma proteins ; process optimization ; proteomics ; quality controluality control
(plasma proteins ; process optimization ; proteomics ; quality controlPlasma proteins ; Process optimization ; Proteomics ; Quality control)

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Biotehnologija, Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)

POVEZANOST RADA