SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump

Blinatumomab (Blincyto<sup>®</sup> injection solution) is classified as a bispecific T-cell engaging (BiTE) antibody and is intended for the treatment of relapsed/refractory acute lymphoblastic leukemia. It requires continuous infusion to maintain therapeutic levels. Therefore, it is oft...

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Main Authors: Megumi Takano, Motoki Inoue, Yuko Ikeda, Hidenori Kage, Tohru Inokawa, Kazuhiko Nakadate, Takeo Yasu, Yasumasa Tsuda, Kazumi Goto
Format: Article
Language:English
Published: MDPI AG 2023-03-01
Series:International Journal of Molecular Sciences
Subjects:
Online Access:https://www.mdpi.com/1422-0067/24/6/5729
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author Megumi Takano
Motoki Inoue
Yuko Ikeda
Hidenori Kage
Tohru Inokawa
Kazuhiko Nakadate
Takeo Yasu
Yasumasa Tsuda
Kazumi Goto
author_facet Megumi Takano
Motoki Inoue
Yuko Ikeda
Hidenori Kage
Tohru Inokawa
Kazuhiko Nakadate
Takeo Yasu
Yasumasa Tsuda
Kazumi Goto
author_sort Megumi Takano
collection DOAJ
description Blinatumomab (Blincyto<sup>®</sup> injection solution) is classified as a bispecific T-cell engaging (BiTE) antibody and is intended for the treatment of relapsed/refractory acute lymphoblastic leukemia. It requires continuous infusion to maintain therapeutic levels. Therefore, it is often administered at home. Monoclonal antibodies, which are administered intravenously, have the potential to leak depending on the nature of the administration devices. Therefore, we investigated device-associated causes of blinatumomab leakage. We observed no apparent changes to the filter and its materials after exposure to the injection solution and surfactant. From scanning electron microscopic images, precipitate on the surface of the filters was observed after physical stimulation of the injection solution. Therefore, physical stimulations should be avoided during the prolonged administration of blinatumomab. In conclusion, the findings of this study assist in the safe administration of antibodies using portable infusion pumps, taking into consideration the composition of drug excipients and the choice of filter type and structure.
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spelling doaj.art-8db6e099d4b541a0a8a13f6ca464980c2023-11-17T11:38:28ZengMDPI AGInternational Journal of Molecular Sciences1661-65961422-00672023-03-01246572910.3390/ijms24065729SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion PumpMegumi Takano0Motoki Inoue1Yuko Ikeda2Hidenori Kage3Tohru Inokawa4Kazuhiko Nakadate5Takeo Yasu6Yasumasa Tsuda7Kazumi Goto8Department of Pharmacy, St. Luke’s International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, JapanDepartment of Molecular Pharmaceutics, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, JapanDepartment of Pharmacy, St. Luke’s International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, JapanDepartment of Pharmacy, St. Luke’s International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, JapanDepartment of Pharmacy, St. Luke’s International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, JapanDepartment of Basic Science, Educational and Research Center for Pharmacy, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, JapanDepartment of Medicinal Therapy Research, Pharmaceutical Education and Research Center, Meiji Pharmaceutical University, 2-522-1, Noshio, Kiyose, Tokyo 204-8588, JapanDepartment of Pharmacy, St. Luke’s International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, JapanDepartment of Pharmacy, St. Luke’s International Hospital, 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560, JapanBlinatumomab (Blincyto<sup>®</sup> injection solution) is classified as a bispecific T-cell engaging (BiTE) antibody and is intended for the treatment of relapsed/refractory acute lymphoblastic leukemia. It requires continuous infusion to maintain therapeutic levels. Therefore, it is often administered at home. Monoclonal antibodies, which are administered intravenously, have the potential to leak depending on the nature of the administration devices. Therefore, we investigated device-associated causes of blinatumomab leakage. We observed no apparent changes to the filter and its materials after exposure to the injection solution and surfactant. From scanning electron microscopic images, precipitate on the surface of the filters was observed after physical stimulation of the injection solution. Therefore, physical stimulations should be avoided during the prolonged administration of blinatumomab. In conclusion, the findings of this study assist in the safe administration of antibodies using portable infusion pumps, taking into consideration the composition of drug excipients and the choice of filter type and structure.https://www.mdpi.com/1422-0067/24/6/5729blinatumomableakagecontinuous infusionbispecific T-cell engagerspolysorbate 80filter
spellingShingle Megumi Takano
Motoki Inoue
Yuko Ikeda
Hidenori Kage
Tohru Inokawa
Kazuhiko Nakadate
Takeo Yasu
Yasumasa Tsuda
Kazumi Goto
SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump
International Journal of Molecular Sciences
blinatumomab
leakage
continuous infusion
bispecific T-cell engagers
polysorbate 80
filter
title SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump
title_full SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump
title_fullStr SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump
title_full_unstemmed SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump
title_short SEM Observation of the Filter after Administration of Blinatumomab: A Possibility of Leakage during Home Administration Using a Portable Infusion Pump
title_sort sem observation of the filter after administration of blinatumomab a possibility of leakage during home administration using a portable infusion pump
topic blinatumomab
leakage
continuous infusion
bispecific T-cell engagers
polysorbate 80
filter
url https://www.mdpi.com/1422-0067/24/6/5729
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