Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method.

Autor: Harazono A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan. Electronic address: harazono@nihs.go.jp., Shibata H; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan., Kiyoshi M; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan., Muto T; Biotechnology Labs., Pharmaceutical Technology, Astellas Pharma Inc., 5-2-3, Tokodai, Tsukuba-shi, Ibaraki, 300-2698, Japan., Fukuda J; Product Strategy Group, Corporate Strategy and Planning Department, Kyowa Hakko Kirin Co., Ltd, Otemachi Financial City Grand Cube, 1-9-2, Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan., Torisu T; Product Operations, Global Vaccine Business Unit, Takeda Pharmaceutical Company Limited, 4720, Takeda, Mitsui, Hikari, Yamaguchi, 743-0011, Japan., Saitoh S; Quality Development Dept., Pharmaceutical Technology Div., Chugai Pharma Manufacturing Co., Ltd., 5-1, Ukima, 5-chome, Kita-ku, Tokyo, 115-8543, Japan., Nishimura H; Pharmaceutical Laboratory, Mochida Pharmaceutical Co., Ltd, 342 Gensuke, Fujieda, Shizuoka, 426-8640, Japan., Uchiyama S; U-Medico Inc., 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan., Ishii-Watabe A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, Tonomachi 3-25-26, Kawasaki-ku, Kanagawa, 210-9501, Japan.
Jazyk: angličtina
Zdroj: Biologicals : journal of the International Association of Biological Standardization [Biologicals] 2019 Jan; Vol. 57, pp. 46-49. Date of Electronic Publication: 2018 Dec 13.
DOI: 10.1016/j.biologicals.2018.12.003
Abstrakt: Insoluble particulate matter test for injections in pharmacopoeia is mandatory for parenteral drug products. In this test using light obscuration, four measurements of at least 5-mL are required. Since therapeutic protein injections of low dosage volumes are getting more popular, reduction of test volumes is desired. In this collaborative study, the impact of lower measurement volume on the accuracy and precision of particle count was evaluated using 2, 5, 10, and 25-μm polystyrene count standards for the validity of test with reduced sample volumes. Good accuracy (3000 particles/mL ± 10%) was obtained at all measurement volumes, and the inter-run variability (RSD) was the same levels between 5 and 1 mL. Although the inter-run variability increased at 0.2 mL, it was below 5%. These results indicated that light obscuration method can be used with 5 mL-0.2 mL, and that it is feasible for monitoring particles ≥2 μm.
(Copyright © 2018. Published by Elsevier Ltd.)
Databáze: MEDLINE
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