Abstract
The world remains cautiously optimistic about a COVID-19 vaccine that is relatively safe and efficacious and that offers sufficient long-lasting protection/immunity by neutralizing the virus infectivity. However, key technical hurdles pertaining to antigen-adjuvant formulation, delivery, and manufacturing challenges of lipid nanoparticles (LNPs) for mRNA vaccines and stability of formulations need to be addressed for successful product development and stockpiling. In addition, the dosage form, the dosage level and regimen for eliciting a protective immune response remain to be established. The high dependence of global supply chains and demand-supply to sourcing quality raw materials, glassware and other supplies, along with the stress on existing production capacities and platform-specific manufacturing challenges could impede vaccine development and access. This article provides critical analysis of vaccine development processes and unit operations that can derail the pandemic response, and also extends to other emerging infectious disease development efforts – issues that take on added significance given the global mandate for an accelerated and at-risk development path to tackle the COVID-19 pandemic.
Keywords: COVID; GMP manufacturing; adjuvants; immune response; mRNA-lipid nanoparticle; supply chains; vaccine dose; vaccines.
【저자키워드】 immune response, Vaccines, adjuvants, COVID, GMP manufacturing, mRNA-lipid nanoparticle, supply chains, vaccine dose, 【초록키워드】 Vaccine, Vaccine development, COVID-19 vaccine, immune response, pandemic, Stress, Vaccines, mRNA vaccine, COVID-19 pandemic, adjuvants, Infectious disease, immune, Lipid nanoparticles, mRNA vaccines, supply chains, vaccine dose, stability, mRNA, Emerging infectious disease, Neutralizing, Critical, Lipid nanoparticle, Analysis, Safe, regimen, GMP, dosage, protective immune response, effort, dosage level, glassware, virus infectivity, offer, addition, provide, added, long-lasting, addressed, accelerated, 【제목키워드】 Analysis, COVID-19 vaccine development,