Module 9 2024

03/09/2024

Specific Considerations for Vaccines

Technical

The Organisation for Professionals in Regulatory Affairs

17

Vaccines are Complex Biological Products

• Full characterization is not possible by analytical methods • Development of robust manufacturing process and control methods is critical to ensure quality and consistency of production

Human Papilloma Virus Virus Like Particle (Prophylactic Vaccine) MW ~ 20,000,000 Da

Simvastatin (Cholesterol Lowering) MW ~ 200 Da

The Organisation for Professionals in Regulatory Affairs

18

9