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Evaluation of the reproducibility and positive controls of cellular immortality test for the detection of immortalized cellular impurities in human cell-processed therapeutic products.
Hirai, Takamasa; Kono, Ken; Kusakawa, Shinji; Yasuda, Satoshi; Sawada, Rumi; Morishita, Akihiko; Hata, Shinko; Wakita, Atsushi; Kageyama, Takayasu; Takahashi, Ryo; Watanabe, Sono; Shiraishi, Norihiko; Sato, Yoji.
Afiliación
  • Hirai T; Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
  • Kono K; Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
  • Kusakawa S; Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
  • Yasuda S; Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
  • Sawada R; Department of Quality Assurance Science for Pharmaceuticals, Graduate School of Pharmaceutical Sciences, Nagoya City University, Aichi, Japan.
  • Morishita A; Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
  • Hata S; Ig-M Co., Hyogo, Japan.
  • Wakita A; Ig-M Co., Hyogo, Japan.
  • Kageyama T; Clinical Pathology Division, Tsukuba Research Institute, BoZo Research Center Inc., Ibaraki, Japan.
  • Takahashi R; Clinical Pathology Division, Tsukuba Research Institute, BoZo Research Center Inc., Ibaraki, Japan.
  • Watanabe S; Clinical Pathology Division, Tsukuba Research Institute, BoZo Research Center Inc., Ibaraki, Japan.
  • Shiraishi N; Analytical Research Group, Research Division, HEALIOS K.K., Hyogo, Japan.
  • Sato Y; New Healthcare Solutions, Corporate Strategy Department, Strategy Division, Kyowakirin Co., Ltd., Tokyo, Japan.
Regen Ther ; 21: 540-546, 2022 Dec.
Article en En | MEDLINE | ID: mdl-36382135
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Diagnostic_studies / Prognostic_studies Idioma: En Revista: Regen Ther Año: 2022 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Diagnostic_studies / Prognostic_studies Idioma: En Revista: Regen Ther Año: 2022 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Países Bajos