The Role of the Biomanufacturing Industry in Developing Diagnostics and mRNA Vaccines Against COVID-19

COVID-19, caused by a novel virus, SARS-CoV-2, has now become international endemic. It posed a challenge to the global biomanufacturing industry for rapid diagnostics, effective therapeutics, and scalable vaccine manufacturing. The biomanufacturing industry played a central role in meeting this challenge by accelerating the development, production, and distribution of SARS‑CoV‑2 diagnostic assays and vaccines. This review provides an overview of SARS‑CoV‑2 biology, major variants, followed by a detailed examination of diagnostic technologies. We further highlight the development process of mRNA vaccine technologies, emphasizing advances in lipid nanoparticle formulation, and large‑scale manufacturing. The review also discusses the biomanufacturing sector’s rapid mobilization to overcome supply‑chain constraints, workforce shortages, and acceleration in regulatory affairs. Collectively, this work underscores how scientific innovation, industrial agility, and cross‑sector collaboration enabled the rapid deployment of diagnostics and vaccines that were essential to controlling the COVID‑19 pandemic.