Eli Lilly Innovation Center, 450 Kendall Street, Cambridge, MA 02142, USA.
Novartis Institutes for BioMedical Research, 700 Main Street, Cambridge, MA 02139, USA.
J Control Release. 2020 May 10;321:475-482. doi: 10.1016/j.jconrel.2020.02.036. Epub 2020 Feb 24.
Subcutaneous (SC) delivery of biotherapeutics is well established as a route of administration across many therapeutic areas and has been shown to be effective and well-tolerated. It can offer several advantages over intravenous administration. This notwithstanding, there remain critical development issues and knowledge gaps in SC drug delivery. To articulate and address these issues, the SC Drug Delivery and Development Consortium was convened in 2018 as a pre-competitive collaboration of industry experts in drug delivery, device development, and commercialization. In this review, we outline the Consortium's vision and mission in advancing the development of patient-centered biotherapeutics and establishing a collaborative organization that facilitates open sharing of information and gives voice to diverse viewpoints from SC experts across industries and disciplines. Additionally, we describe the current landscape and challenges associated with SC administration of therapeutic proteins (specifically monoclonal antibodies) and offer insights into potential solutions to these challenges within the context of 8 problem statements developed by the Consortium to highlight key gaps, unmet needs, and actionable issues. Current and future opportunities to accelerate progress in the field through technological advances and the development of drug delivery tools are also discussed.
皮下（SC）给药在许多治疗领域已被广泛确立为一种给药途径，并且已被证明是有效且耐受良好的。与静脉给药相比，它具有许多优势。尽管如此，在 SC 药物输送方面仍然存在关键的开发问题和知识空白。为了阐明和解决这些问题，2018 年成立了 SC 药物输送和开发联盟，这是一个由药物输送、设备开发和商业化方面的行业专家组成的非竞争性合作组织。在这篇综述中，我们概述了联盟在推进以患者为中心的生物治疗药物开发方面的愿景和使命，并建立了一个协作组织，促进信息的公开共享，并为来自不同行业和学科的 SC 专家提供多样化的观点。此外，我们还描述了与治疗性蛋白质（特别是单克隆抗体）SC 给药相关的当前现状和挑战，并在联盟制定的 8 个问题陈述的背景下提供了对这些挑战的潜在解决方案的见解，这些问题陈述突出了关键差距、未满足的需求和可采取的措施。还讨论了通过技术进步和药物输送工具的开发来加速该领域进展的当前和未来机会。
