Suppr超能文献

皮下注射用单克隆抗体和蛋白治疗制剂:高浓度、低容量与低浓度、高容量。

Monoclonal antibody and protein therapeutic formulations for subcutaneous delivery: high-concentration, low-volume vs. low-concentration, high-volume.

机构信息

Medical Affairs, Enable Injections, Inc, Cincinnati, OH, USA.

Manufacturing Sciences, Takeda Pharmaceuticals, Brooklyn Park, MN, USA.

出版信息

MAbs. 2023 Jan-Dec;15(1):2285277. doi: 10.1080/19420862.2023.2285277. Epub 2023 Nov 27.

Abstract

Biologic drugs are used to treat a variety of cancers and chronic diseases. While most of these treatments are administered intravenously by trained healthcare professionals, a noticeable trend has emerged favoring subcutaneous (SC) administration. SC administration of biologics poses several challenges. Biologic drugs often require higher doses for optimal efficacy, surpassing the low volume capacity of traditional SC delivery methods like autoinjectors. Consequently, high concentrations of active ingredients are needed, creating time-consuming formulation obstacles. Alternatives to traditional SC delivery systems are therefore needed to support higher-volume biologic formulations and to reduce development time and other risks associated with high-concentration biologic formulations. Here, we outline key considerations for SC biologic drug formulations and delivery and explore a paradigm shift: the flexibility afforded by low-to-moderate-concentration drugs in high-volume formulations as an alternative to the traditionally difficult approach of high-concentration, low-volume SC formulation delivery.

摘要

生物制剂被用于治疗多种癌症和慢性疾病。虽然这些治疗方法中的大多数都是由经过培训的医疗保健专业人员通过静脉内给药,但一种明显的趋势已经出现,倾向于皮下(SC)给药。生物制剂的 SC 给药带来了一些挑战。生物制剂通常需要更高的剂量才能达到最佳疗效,超过了传统 SC 给药方法(如自动注射器)的低容量能力。因此,需要高浓度的有效成分,这就产生了耗时的配方障碍。因此,需要替代传统的 SC 给药系统来支持大容量的生物制剂配方,并减少与高浓度生物制剂配方相关的开发时间和其他风险。在这里,我们概述了 SC 生物药物配方和给药的关键考虑因素,并探讨了一种范式转变:低至中等浓度药物在高容量配方中的灵活性,作为替代传统高浓度、低容量 SC 配方给药的困难方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eaf4/10793682/67bcc6e67eb2/KMAB_A_2285277_F0001_OC.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验