Evaluation of the physicochemical and biological stability of reconstituted and diluted SB2 (infliximab).

Journal: European journal of hospital pharmacy : science and practice
Published Date:

Abstract

OBJECTIVES: To evaluate the critical quality attributes that might affect the stability of an infliximab biosimilar (SB2, Flixabi) when reconstituted or diluted and stored under refrigeration and at room temperature.

Authors

  • Jihyun Kim
    Quality Evaluation Team, Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.
  • Jihyun Chung
    Quality Evaluation Team, Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.
  • Sujin Park
    Quality Evaluation Team, Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.
  • Saem Jung
    Quality Evaluation Team, Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.
  • Dukwon Kang
    Quality Evaluation Team, Samsung Bioepis Co., Ltd, Incheon, Republic of Korea.

Keywords

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