Drug Delivery System
Online ISSN : 1881-2732
Print ISSN : 0913-5006
ISSN-L : 0913-5006
Feature articles “Protein engineering technology for next-generation biodrug development” Editor : Yasuo Tsutsumi
Safety evaluation of biotechnology-derived pharmaceuticals
Tomoaki Inoue, Kenji Yasugi
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Keywords: Biotechnology-derived pharmaceuticals, immunogenicity, cytokine release, drug delivery system, polyethylene glycol-conjugation(PEGylation)
JOURNAL FREE ACCESS

2011 Volume 26 Issue 6 Pages 622-627

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Abstract
Actions of biologics are often species-specific. Pharmacological active animals would be used for preclinical safety studies. Characteristics of toxicities of biologics are immunogenicity, cytokine releases and other immunological effects. In vitro evaluation methods using human cells are under investigation. In addition, examples of effects of DDS on safety (effects of pegylation on immunogenicity, accelerated blood clearance by pegylated liposomes, and skin irritation in sustained release formulations) are shown.
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© 2011 Japan Society of Drug Delivery System
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