Protein PEGylation for the design of biobetters: from reaction to purification processes
authors Santos, JHPM; Torres-Obreque, KM; Meneguetti, GP; Amaro, BP; Rangel-Yagui, CO
nationality International
journal BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES
author keywords PEGylation; Biobetters; Biological drugs; Polyethylene glycol; Protein purification; Site-specific PEGylation
keywords SITE-SPECIFIC PEGYLATION; CAPILLARY ELECTROPHORETIC SEPARATION; MASS-SPECTROMETRIC ANALYSIS; AQUEOUS 2-PHASE SYSTEMS; MOLECULAR-WEIGHT; IMMUNOLOGICAL-PROPERTIES; POLY(ETHYLENE GLYCOL); ALPHA-LACTALBUMIN; SERUM-ALBUMIN; CYTOCHROME-C
abstract The covalent attachment of polyethylene glycol (PEG) to therapeutical proteins is an important route to develop biobetters for biomedical, biotech and pharmaceutical industries. PEG conjugation can shield antigenic epitopes of the protein, reduce degradation by proteolytic enzymes, enhance long-term stability and maintain or even improve pharmacokinetic and pharmacodynamics characteristics of the protein drug. Nonetheless, correct information in terms of the PEGylation process from reaction to downstream processing is of paramount importance for the industrial application and processing scale-up. In this review we present and discuss the main steps in protein PEGylation, namely: PEGylation reaction, separation of the products and final characterization of structure and activity of the resulting species. These steps are not trivial tasks, reason why bioprocessing operations based on PEGylated proteins relies on the use of analytical tools according to the specific pharmaceutical conjugate that is being developed. Therefore, the appropriate selection of the technical and analytical methods may ensure success in implementing a feasible industrial process.
publisher UNIV SAO PAULO, CONJUNTO QUIMICAS
issn 1984-8250
year published 2018
volume 54
digital object identifier (doi) 10.1590/s2175-97902018000001009
web of science category Pharmacology & Pharmacy
subject category Pharmacology & Pharmacy
unique article identifier WOS:000464304700009
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journal analysis (jcr 2017):
journal impact factor 0.483
5 year journal impact factor 0.910
category normalized journal impact factor percentile 3.640
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