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Characterisation of the site-specific monoPEGylated rhG-CSF analogue pegteograstim

Authors
Hong, JeungwoonLee, ByoungjuKang, KwanyubLee, Seung-HoonRyu, JaehwanJung, GangsooOh, JaetaekJo, Eui-CheolKim, Chan-Wha
Issue Date
1월-2018
Publisher
ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
Keywords
Pegteograstim; Filgrastim; rhG-CSF analogue; Maleimide-PEG; PEGylation; Neutropenia
Citation
BIOLOGICALS, v.51, pp.54 - 61
Indexed
SCIE
SCOPUS
Journal Title
BIOLOGICALS
Volume
51
Start Page
54
End Page
61
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/78435
DOI
10.1016/j.biologicals.2017.10.002
ISSN
1045-1056
Abstract
We describe the characterisation of a novel monoPEGylated recombinant human granulocyte colony-stimulating factor analogue, pegteograstim (Neulapeg), prepared by site-specific 20 kDa maleimide-PEG conjugation. An additional cysteine was inserted between G1y136 and Ala137 of filgrastim (methionyl human granulocyte colony-stimulating factor) for site-specific PEGylation, and Cys18 of filgrastim was replaced with Ser18 to prevent unwanted PEGylation. Pegteograstim was produced by Escherichia coli and purified by cation exchange chromatography, and its structural, physicochemical, biological and immunological properties were investigated. Male Sprague-Dawley rats were administered pegteograstim (100 mu g/kg) and the pharmacokinetics and pharmacodynamics compared with those of filgrastim. The results of long-term stability testing of pegteograstim revealed no significant change in its quality attributes at 2-8 degrees C for 36 months. In addition, pegteograstim was stable under the accelerated conditions (25 +/- 2 degrees C, RH of 60 +/- 5%) for 6 months. The site-specific monoPEGylated pegteograstim is a highly pure, stable and novel drug for long-lasting treatment of chemotherapy-induced neutropenia.
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