Collaborative study using common samples to evaluate the performance of anti-drug antibody assays constructed by different companies.

Autor: Niimi S; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku Kawasaki-shi, Kanagawa, 210-9501, Japan. Electronic address: niimi19551113@gmail.com., Nishimiya K; Chugai Pharmaceutical Co., Ltd, 200 Kajiwara, Kamakura City, Kanagawa, 247-8530, Japan., Nishidate M; Chugai Pharmaceutical Co., Ltd, 200 Kajiwara, Kamakura City, Kanagawa, 247-8530, Japan., Saito T; Astellas Pharma Inc., 21 Miyukigaoka, Tsukubashi, Ibaraki, 305-8585, Japan., Minoura K; Astellas Pharma Inc., 21 Miyukigaoka, Tsukubashi, Ibaraki, 305-8585, Japan., Kadotsuji K; Sumitomo Dainippon Pharma Co., Ltd, 33-94 Enokicho, Suita-shi, Osaka, 554-0022, Japan., Shimakura J; Sumitomo Dainippon Pharma Co., Ltd, 1-13-1 Kyobashi, Chuo-ku, Tokyo, 104-8356, Japan., Shigemizu H; CMIC Pharma Science Co., Ltd, Formerly JCL Bioassay Corporation, 17-18, Nakahata-cho, Nishiwaki-shi, Hyogo, 677-0032, Japan., Hosogi J; Kyowa Hakko Kirin Co., Ltd, 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-9731, Japan., Adachi M; Kyowa Hakko Kirin Co., Ltd, 1188, Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-9731, Japan., Hashimoto T; LSI Medience Corporation, 30-1, Shimura 3-chome, Itabashi-ku, Tokyo, 174-8555, Japan., Mori T; LSI Medience Corporation, 30-1, Shimura 3-chome, Itabashi-ku, Tokyo, 174-8555, Japan., Harada H; LSI Medience Corporation, 14-1 Sunayama, Kamisu, Ibaraki, 314-0255, Japan., Yamamoto KI; LSI Medience Corporation, 1285 Kurisaki-machi, Uto, Kumamoto, 869-0425, Japan., Nakamura T; Shin Nippon Biomedicals Laboratories, Ltd, 2438 Miyanoura, Kagoshima, 891-1394, Japan., Nomura T; Shin Nippon Biomedicals Laboratories, Ltd, 2438 Miyanoura, Kagoshima, 891-1394, Japan., Yamaguchi I; Sumika Chemical Analysis Service, Ltd, 3-1-135 Kasugadenaka, Konohana-ku, Osaka, 554-0022, Japan., Sonehara K; Sumika Chemical Analysis Service, Ltd, 3-1-135 Kasugadenaka, Konohana-ku, Osaka, 554-0022, Japan., Ishii-Watabe A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku Kawasaki-shi, Kanagawa, 210-9501, Japan., Kawasaki N; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku Kawasaki-shi, Kanagawa, 210-9501, Japan; Graduate School of Medical Life Science, Yokohama City University, 1-7-29 Suehiro-cho, Tsurumi-ku, Yokohama, 230-0045, Japan.
Jazyk: angličtina
Zdroj: Drug metabolism and pharmacokinetics [Drug Metab Pharmacokinet] 2018 Apr; Vol. 33 (2), pp. 125-132. Date of Electronic Publication: 2018 Mar 08.
DOI: 10.1016/j.dmpk.2018.03.002
Abstrakt: This study was undertaken to evaluate the performance of anti-drug antibody (ADA) assays constructed by each participating company using common samples including ADA, drug and human serum. The ADA assays constructed by each company showed good sensitivity and precision for evaluation of ADA. Cut points for screening and confirmatory assays and assay selectivity were determined by various calculation methods. In evaluations of blind ADA samples, nearly similar results were obtained by the study companies in determinations of whether samples were positive or negative except at the lowest sample concentration (5 ng/mL). In measurement of drug tolerance, for almost samples containing ADA and drugs, more positive results were obtained in assays using acid dissociation compared to those without acid dissociation. Overall, the performance of ADA assays constructed by the 10 companies participating in this study was acceptable in terms of sensitivity and reproducibility for detection and evaluation of immunogenicity in both patients and healthy subjects. On the other hand, based on results for samples containing ADA and drugs, validity of results for ADA assays conducted without acid dissociation was less meaningful and more difficult to evaluate. Thus, acid dissociation was confirmed to be useful for improving drug tolerance.
(Copyright © 2018 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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