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권준철,권오환,정래웅,김나윤,송선아,최일섭,이준옥,Takahiko Horiuchi 한국통합생물학회 2021 Animal cells and systems Vol.25 No.3
LBAL was developed as an adalimumab (Humira®) biosimilar using Chinese hamster ovary cell lines. Comparable quality, safety, and efficacy between a biosimilar and its reference product should be ensured for regulatory approval. Here, we present the results of a comprehensive physicochemical and biological characterization between LBAL and Humira®. As physicochemical attributes, primary and higher-order structure, N-glycan profile, and disulfide linkage were investigated. Biological attributes were evaluated by target/receptor binding analysis and in vitro/ex vivo cell-based assays, which are linked to mechanisms of action. As a result, LBAL had the identical amino acid sequence, similar post-translational modifications and N-/C-terminal variants, and comparable primary, secondary, and tertiary structures and disulfide linkage profile. However, some differences in N-glycan profiles were observed. Biological activities, including tumor necrosis factor (TNF) binding, TNF-neutralization, apoptosis, Fc receptor binding, and complementdependent cytotoxicity, were largely consistent. Despite a slightly lower antibody-dependent cellular cytotoxicity activity in LBAL, this difference was not significant under physiological conditions. As indicated, this extensive analytical characterization and functional comparison assessment showed that LBAL was similar to Humira®, with minor differences of no clinical relevance. Taken together, our comparative assessment of physicochemical and biological attributes demonstrated that LBAL is structurally and functionally very similar to Humira®, supporting the biosimilarity of clinical efficacy and safety.
이상현(Sang hyun Lee),하창기(Chang gi Ha),안기륜(Ki ryun Ahn),정래웅(Rae woong Jung) 한국자동차공학회 2011 한국자동차공학회 학술대회 및 전시회 Vol.2011 No.11
Recently door outside handles are equipped not only L/F antenna & lock button with capacity sensors but also LED lamps with hard wires. It means more inertia load will be applied during the side impact because of weight.. To increase passenger safety, we need additional anti-open mechanism in door opening mechanism parts. In this paper I suggest new door latch locking mechanism to solve this issue.