SOP for Formulation of Nanoparticles for Vaccine Delivery

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 Study

4.4.2.1 Perform in vitro release studies to determine the release profile of the antigen from the nanoparticles over time.

4.5 Storage

4.5.1 Storage Conditions

4.5.1.1 Store the vaccine nanoparticle formulation at -20°C or 4°C, depending on the antigen’s stability requirements.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
QA: Quality Assurance

6) Documents, if any

Vaccine Nanoparticle Formulation Logbook

7) References, if any

Protocols for nanoparticle-based vaccine formulations

8) SOP Version

Version 1.0

Annexure

Vaccine Nanoparticle Formulation Logbook Template


  
    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

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