Adapting Drug Delivery for High-Volume Home Administration: Poster Presented at PDA Week 2026.

Abstract

The rising prevalence of Biologics and other sensitive therapeutics in clinical practice are rapidly modifying the landscape of subcutaneous (SC) drug delivery. Such route of administration empowers patients with the ability to self-administer at home, reducing the burden of frequent clinic visits and supporting the growing shift toward decentralized, patient-centric healthcare.Traditionally, SC injections have been limited to low volumes (typically ≤2 mL) due to concerns over pain, tissue tolerability, and absorption kinetics. However, emerging therapies-particularly monoclonal antibodies, anti-cancer treatments, and long-acting neurologic formulations-often require higher doses that cannot be feasibly delivered subcutaneously within these conventional volume constraints. Consequently, there is a growing demand for innovative solutions supporting self-administration of larger volumes, without compromising safety, therapeutic efficacy and compliance.Sensing such market pressure, Datwyler extended its range of NeoFlex™ plungers to complete larger containers, supporting the novel on-body injectors designed for slow, controlled delivery, expanding the feasible range of SC administration volumes. A collaborative and open approach among the parties involved with the development of the container closure system (CCS) and the device allows the optimization of pre-verified platform solutions, so to accelerate their time to market and, ultimately, availability to patients.