Regenerative Therapy (Dec 2021)
Biodistribution studies for cell therapy products: Current status and issues
- Yoshiteru Kamiyama,
- Yoichi Naritomi,
- Yuu Moriya,
- Syunsuke Yamamoto,
- Tsukasa Kitahashi,
- Toshihiko Maekawa,
- Masahiro Yahata,
- Takeshi Hanada,
- Asako Uchiyama,
- Akari Noumaru,
- Yoshiyuki Koga,
- Tomoaki Higuchi,
- Masahiko Ito,
- Hiroyuki Komatsu,
- Sosuke Miyoshi,
- Sadaaki Kimura,
- Nobuhiro Umeda,
- Eriko Fujita,
- Naoko Tanaka,
- Taku Sugita,
- Satoru Takayama,
- Akihiko Kurogi,
- Satoshi Yasuda,
- Yoji Sato
Affiliations
- Yoshiteru Kamiyama
- Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan; Corresponding author.
- Yoichi Naritomi
- Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan
- Yuu Moriya
- Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
- Syunsuke Yamamoto
- Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
- Tsukasa Kitahashi
- Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan
- Toshihiko Maekawa
- Bioscience & Engineering Laboratory, FUJIFILM Corp., 577 Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa, Japan
- Masahiro Yahata
- Preclinical Research Unit, Sumitomo Dainippon Pharma Co., Ltd., 3-1-98 Kasugade-naka, Konohana-ku, Osaka, Japan
- Takeshi Hanada
- Drug Metabolism & Pharmacokinetics Research Laboratories, Daiichi Sankyo.Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, Japan
- Asako Uchiyama
- Drug Safety Research Laboratories, Shin Nippon Biomedical Laboratories, Ltd., Kagoshima, Kagoshima, Japan
- Akari Noumaru
- Kumamoto Laboratories, LSIM Safety Institute Corporation, 1285 Kurisaki-machi, Uto, Kumamoto, Japan
- Yoshiyuki Koga
- Kumamoto Laboratories, LSIM Safety Institute Corporation, 1285 Kurisaki-machi, Uto, Kumamoto, Japan
- Tomoaki Higuchi
- Non-clinical Development, Axcelead Drug Discovery Partners, Inc., 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
- Masahiko Ito
- Tsukuba Research Institute, BoZo Research Center Inc., 8 Okubo, Tsukuba, Ibaraki, Japan
- Hiroyuki Komatsu
- Science BD Department, CMIC Pharma Science Co., Ltd., 1-1-1 Shibaura, Minato-ku, Tokyo, Japan
- Sosuke Miyoshi
- Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan
- Sadaaki Kimura
- Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan
- Nobuhiro Umeda
- Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan
- Eriko Fujita
- Drug Discovery Research, Astellas Pharma Inc., 21 Miyukigaoka, Tsukuba, Ibaraki, Japan
- Naoko Tanaka
- Evaluation Center, Terumo Corporation, 1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
- Taku Sugita
- Research, Takeda Pharmaceutical Company Limited, 26-1, Muraoka-Higashi 2-chome, Fujisawa, Kanagawa, Japan
- Satoru Takayama
- Cell Therapy Technology, Healthcare R&D Center, Asahi Kasei Corporation, 2-1 Samejima, Fuji-Shi, Shizuoka, Japan
- Akihiko Kurogi
- Regenerative Medicine Research & Planning Division, ROHTO Pharmaceutical Co., Ltd., Osaka, Japan
- Satoshi Yasuda
- Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, Japan
- Yoji Sato
- Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa, Japan
- Journal volume & issue
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Vol. 18
pp. 202 – 216
Abstract
Information on the biodistribution (BD) of cell therapy products (CTPs) is essential for prediction and assessment of their efficacy and toxicity profiles in non-clinical and clinical studies. To conduct BD studies, it is necessary to understand regulatory requirements, implementation status, and analytical methods. This review aimed at surveying international and Japanese trends concerning the BD study for CTPs and the following subjects were investigated, which were considered particularly important: 1) comparison of guidelines to understand the regulatory status of BD studies in a global setting; 2) case studies of the BD study using databases to understand its current status in cell therapy; 3) case studies on quantitative polymerase chain reaction (qPCR) used primarily in non-clinical BD studies for CTPs; and 4) survey of imaging methods used for non-clinical and clinical BD studies. The results in this review will be a useful resource for implementing BD studies.
