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

COVID-19, caused by the new type of coronavirus SARS-CoV-2, has put an unprecedented impact on health, economy and social areas around the globe. It created an urgent global need 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 integrated overview of SARS‑CoV‑2 biology, clinical manifestations, transmission mechanisms, and major viral variants, followed by a detailed examination of diagnostic technologies. We further highlight the transformative impact of mRNA vaccine technologies, emphasizing advances in lipid nanoparticle formulation, large‑scale manufacturing, and regulatory‑aligned production strategies. The review also discusses the biomanufacturing sector’s rapid mobilization to overcome supply‑chain constraints, workforce shortages, and unprecedented global demand. 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.