Week 8: mRNA-LNP Complexation and Final Product Purification

This week we will be going over the following subjects:

Complexation Process:

  • Mixing conditions: Time, temperature, and lipid-to-mRNA ratio.
  • Monitoring encapsulation efficiency.
  • Optimization for maximum delivery efficacy.

Purification of mRNA-LNPs:

  • Removal of unencapsulated mRNA and free lipids.
  • Chromatographic and filtration techniques.
  • Quality control: Particle size distribution and endotoxin testing.

GMP Considerations:

  • In-process monitoring and control.
  • Documentation of purification steps.
  • Compliance with sterility and endotoxin limits.

Laboratory Work Real-World Application:

  • Example: Purification strategies for mRNA vaccines.