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肿瘤学中单克隆抗体皮下给药策略的全景。

Landscape of Subcutaneous Administration Strategies for Monoclonal Antibodies in Oncology.

机构信息

Institut de Cancérologie Strasbourg Europe, Strasbourg, 67000, France.

Equipe labellisée Ligue contre le Cancer, France.

出版信息

Adv Mater. 2024 Oct;36(40):e2406604. doi: 10.1002/adma.202406604. Epub 2024 Aug 20.

DOI:10.1002/adma.202406604
PMID:39165046
Abstract

In recent decades, subcutaneous (SC) administration of monoclonal antibodies (mAbs) has emerged as a promising alternative to intravenous delivery in oncology, offering comparable therapeutic efficacy while addressing patient preferences. This perspective article provides an in-depth analysis of the technological landscape surrounding SC mAb administration in oncology. It outlines various technologies under evaluation across developmental stages, spanning from preclinical investigations to the integration of established methodologies in clinical practice. Additionally, this perspective article explores emerging trends and prospective trajectories, shedding light on the evolving landscape of SC mAb administration. Furthermore, it emphasizes key checkpoints related to quality attributes essential for optimizing mAb delivery via the SC route. This review serves as a valuable resource for researchers, clinicians, and healthcare policymakers, offering insights into the advancement of SC mAb administration in oncology and its implications for patient care.

摘要

近几十年来,皮下(SC)给药已成为肿瘤学中替代静脉给药的一种有前途的方法,在提供相当疗效的同时还满足了患者的偏好。本文深入分析了肿瘤学中 SC 单克隆抗体给药的技术现状。它概述了不同技术的评估进展,涵盖了从临床前研究到将成熟方法应用于临床实践的各个阶段。此外,本文还探讨了新兴趋势和未来方向,阐明了 SC 单克隆抗体给药领域的演变情况。此外,本文还强调了与通过 SC 途径优化单克隆抗体输送的关键质量属性相关的重要检查点。这篇综述为研究人员、临床医生和医疗保健政策制定者提供了宝贵的资源,深入了解了肿瘤学中 SC 单克隆抗体给药的进展及其对患者护理的影响。

相似文献

1
Landscape of Subcutaneous Administration Strategies for Monoclonal Antibodies in Oncology.肿瘤学中单克隆抗体皮下给药策略的全景。
Adv Mater. 2024 Oct;36(40):e2406604. doi: 10.1002/adma.202406604. Epub 2024 Aug 20.
2
Subcutaneous delivery of monoclonal antibodies: How do we get there?皮下注射单克隆抗体:我们如何实现?
J Control Release. 2018 Sep 28;286:301-314. doi: 10.1016/j.jconrel.2018.08.001. Epub 2018 Aug 2.
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Accelerating the development of novel technologies and tools for the subcutaneous delivery of biotherapeutics.加速新型技术和工具的开发,用于生物疗法的皮下给药。
J Control Release. 2020 May 10;321:475-482. doi: 10.1016/j.jconrel.2020.02.036. Epub 2020 Feb 24.
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Influence of physiochemical properties on the subcutaneous absorption and bioavailability of monoclonal antibodies.理化性质对单克隆抗体的皮下吸收和生物利用度的影响。
MAbs. 2020 Jan 1;12(1):1770028. doi: 10.1080/19420862.2020.1770028.
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Predicting monoclonal antibody pharmacokinetics following subcutaneous administration via whole-body physiologically-based modeling.通过全身体生理模型预测皮下给予单克隆抗体后的药代动力学。
J Pharmacokinet Pharmacodyn. 2020 Oct;47(5):385-409. doi: 10.1007/s10928-020-09691-3. Epub 2020 Jun 4.
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Navigating large-volume subcutaneous injections of biopharmaceuticals: a systematic review of clinical pipelines and approved products.生物制药大容量皮下注射的研究进展:临床研发管线及获批产品的系统评价
MAbs. 2024 Jan-Dec;16(1):2402713. doi: 10.1080/19420862.2024.2402713. Epub 2024 Sep 15.
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Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration.小型猪作为静脉注射和皮下注射后单克隆抗体药代动力学的潜在可转化模型。
MAbs. 2012 Mar-Apr;4(2):243-55. doi: 10.4161/mabs.4.2.19387. Epub 2012 Mar 1.
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Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities.生物制剂的皮下给药:当前挑战与机遇概述。
BioDrugs. 2018 Oct;32(5):425-440. doi: 10.1007/s40259-018-0295-0.
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Pharmaceutical and biotech industry perspectives on optimizing patient experience and treatment adherence through subcutaneous drug delivery design.制药和生物技术行业如何通过优化皮下药物输送设计改善患者体验和治疗依从性
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Drug Des Devel Ther. 2021 Jan 13;15:159-170. doi: 10.2147/DDDT.S287323. eCollection 2021.

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