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 |