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Manufacturing platforms for vaccines and biologic drugs in resource-limited settings: Challenges, innovations, and pathways to sustainable access

Aug 2026 · Annales Academiae Medicae Silesiensis · 0 citations · 77 references

Abstract

Demand for vaccines and biologics continues to rise across human and veterinary health, yet low-resource settings such as Africa carry a disproportionate burden of human immunodeficiency virus, hepatitis B, malaria, tuberculosis, and neglected tropical diseases. This review evaluates manufacturing technologies and strategies that can strengthen local production capacity to improve biologic access, pandemic preparedness, and outbreak response. A structured narrative review was conducted, guided by the SANRA framework, using peer-reviewed literature published between 2015 and 2026 and retrieved from PubMed/Medline, Scopus, Web of Science, and Google Scholar, supplemented by relevant grey literature on biologics manufacturing in low-resource settings. No single platform is universally optimal; selection should be matched to local capacity, target disease, and sustainability. Egg-based and cell-culture systems are accessible but limited in speed and scalability, while mRNA platforms adapt fastest yet depend on cold-chain and reagent infrastructure rarely available locally. Recombinant protein and virus-like particle platforms emerged as the most pragmatic compromise, combining thermostability with feasible bioprocessing. Across platforms, sustainable production depended less on the technology than on cross-cutting enablers: modular and single-use manufacturing, digital process control, regulatory harmonisation and World Health Organization prequalification, workforce development, and blended financing. Africa’s approximately 1% share of global vaccine supply underscores that equitable access requires these enablers to advance in coordination. Meeting the growing need for biologics requires capacity building, infrastructure investment, public-private partnerships, and dedicated funding reducing import dependence and improving pandemic readiness, as the coronavirus disease 2019 pandemic made clear.

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