mRNA Technology & Next-Gen Vaccine Development

Course Overview

Explore the cutting-edge science behind mRNA vaccine technology that revolutionized COVID-19 response. This course dives deep into the mechanisms, formulation, delivery systems, storage, and safety assessments of mRNA-based therapeutics and vaccines. Ideal for pharma students and professionals aiming to understand the future of vaccine science.

Syllabus

• 📘 Full Course Syllabus
• 🔹 Week 1: Introduction to mRNA
• Topics Covered:
• • History of RNA-based therapeutics
• • Central dogma and mRNA’s biological role
• • mRNA transcription and translation
• • Types of RNA: mRNA, tRNA, rRNA, siRNA, miRNA
• • Natural degradation of mRNA in cells
• • Why mRNA is now a viable drug platform
• • Key scientific breakthroughs enabling mRNA technology (e.g. modified nucleosides)
• Learning Outcome:
• Understand the molecular biology basics of mRNA and why it became important for therapeutic development.
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• 🔹 Week 2: Vaccine Design & Delivery
• Topics Covered:
• • mRNA design: codon optimization, UTRs, cap and tail modifications
• • Self-amplifying vs conventional mRNA
• • Lipid Nanoparticles (LNPs) as delivery vehicles
• • Stability, transport, and storage challenges
• • Preclinical formulation and testing
• • Comparing mRNA vaccine formulation vs traditional vaccines
• • Adjuvants in mRNA vaccines (or lack thereof)
• Hands-On/Visual:
• Interactive simulation of LNP delivery mechanism
• Learning Outcome:
• Understand how mRNA is stabilized, formulated, and delivered into the body safely and effectively.
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• 🔹 Week 3: Clinical Trials & Regulatory
• Topics Covered:
• • Overview of clinical trial phases (I, II, III, IV)
• • Regulatory frameworks (FDA, EMA, CDSCO) for mRNA vaccines
• • Safety considerations specific to mRNA
• • Immunogenicity: innate immune responses to mRNA
• • Side effects and public perception
• • Emergency Use Authorization (EUA) vs full approval
• • CMC (Chemistry, Manufacturing & Control) considerations
• Learning Outcome:
• Gain a regulatory, safety, and quality control perspective of mRNA vaccine development.
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• 🔹 Week 4: Case Studies & Future Applications
• Topics Covered:
• • Pfizer-BioNTech & Moderna: Development process, trial data, public rollout
• • CureVac and challenges with early formulations
• • mRNA in flu, Zika, RSV vaccine pipelines
• • mRNA for cancer immunotherapy and personalized neoantigen vaccines
• • Autoimmune disease potential
• • mRNA for rare diseases and protein replacement therapy
• • Global manufacturing capacity and cold chain logistics
• Activity:
• • Final Quiz
• • Optional mini-project: Compare mRNA tech with viral vector vaccines
• Learning Outcome:
• Understand the real-world impact, success stories, and potential future applications of mRNA tech.

Prerequisites

- Basic knowledge of molecular biology or biotechnology
- Familiarity with vaccine concepts and drug development life cycle