Standard Operating Procedure for Formulation of Nanoparticles for Vaccine Delivery

1) Purpose

This SOP outlines the procedure for formulating nanoparticles designed to deliver vaccines. Nanoparticles are used in vaccine delivery to improve antigen stability, enhance immune response, and provide controlled release of antigens.

2) Scope

This SOP applies to laboratory personnel responsible for preparing nanoparticle-based vaccine formulations for both therapeutic and prophylactic applications.

3) Responsibilities

• Operators: Responsible for formulating nanoparticles for vaccine delivery as per this SOP.
• QA: Ensures the nanoparticle vaccine formulations meet required specifications for antigen loading, particle size, and stability.

4) Procedure

4.1 Selection of Materials

4.1.1 Antigen and Adjuvant Selection

• 4.1.1.1 Select the appropriate antigen (e.g., protein, peptide, or inactivated virus) and any adjuvants to enhance the immune response.

4.2 Nanoparticle Formation

4.2.1 Nanoprecipitation Method

• 4.2.1.1 Prepare nanoparticles using the nanoprecipitation method, ensuring that the antigen and adjuvant are encapsulated or adsorbed onto the surface of the nanoparticles.

4.3 Antigen Loading

4.3.1 Antigen Incorporation

• 4.3.1.1 Incorporate the antigen into the nanoparticle matrix or attach it to the surface of the nanoparticles to ensure adequate immune system recognition.

4.4 Characterization

4.4.1 Particle Size and Zeta Potential

• 4.4.1.1 Measure the particle size and zeta potential using dynamic light scattering (DLS) to ensure uniformity and stability of the nanoparticle formulation.

4.4.2 Antigen Release

  

    
Date
    
Batch Number
    
Antigen/Adjuvant
    
Particle Size
    
Zeta Potential
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Antigen/Adjuvant
    
Size in nm
    
Zeta Potential (mV)
    
Operator Name
    
QA Name