From cold chain to home care: emerging pharmaceutical challenges in monoclonal antibody therapy

Introduction Monoclonal antibodies (mAbs) are increasingly shifting from hospital intravenous infusion to subcutaneous self-administration at home, exposing fragile glycoproteins to thermal excursions, mechanical stress, and mishandling. These vulnerabilities are well documented in vitro and in preclinical models; however, their causal link to clinical treatment failure in home settings has not yet been established through prospective interventional or epidemiological studies.Areas covered This review examines the pharmaceutical challenges across the mAb lifecycle: degradation mechanisms, formulation strategies for high-concentration subcutaneous products (excipients, lyophilization, hyaluronidase-facilitated delivery), cold-chain vulnerabilities from manufacture to home storage, comparative analysis of intravenous versus subcutaneous administration, home-based practice challenges, and emerging technologies including IoT monitoring, smart packaging, and wearable injectors. Literature from pharmaceutical sciences, cold-chain engineering, device technology, and clinical practice (1974–2026) was synthesized.Expert Opinion Ensuring mAb stability outside institutional walls requires an integrated four-pillar framework: mechanism-based formulation design, intelligent supply chain technologies, human-centered device engineering, and comprehensive patient education with digitally enabled professional support. While degradation mechanisms are well characterized, their translation into clinical outcomes in decentralized care remains an open research question. Future efforts should focus on thermostable formulations, validated temperature monitoring, intuitive delivery devices, and continuous care frameworks extending pharmaceutical expertise into patients’ homes.