DOI: 10.1093/abt/tbag034 ISSN: 2516-4236

Delivery Devices and Container Closure Systems for Co-Formulated and Co-Administered Biologics

Ming Zhou, Kevin Duffy, Chris Mitchener, Galen Huaiqiu Shi, David Collins

Abstract

The rapid evolution of antibody-based biologics is transforming the management of chronic conditions and driving innovation in drug-delivery devices and container closure systems (CCS). Combination therapy enabled through coformulation or coadministration offers the potential for synergistic outcomes that are not achievable with single-drug products. This review examines development pathways and emerging strategies for delivery devices and CCS that support antibody-biologic coformulations and coadministration, from clinical trials through commercialization. We evaluate established technologies with an emphasis on design and delivery mechanisms, and on key technical considerations including compatibility with dual-molecule formulations, protein–protein interactions, sterilization approaches, container closure integrity, and human factors in CCS and device design. We also highlight emerging technologies and future opportunities for advancement. Overall, this review provides insights into the challenges and innovations shaping CCS and delivery systems for co-formulated or co-administered antibody biologics.

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