Standard Operating Procedure for Formulation of Protein-Based Nanoparticles
1) Purpose
This SOP outlines the procedure for formulating protein-based nanoparticles, which are used for the delivery of peptides, proteins, or therapeutic agents. Protein-based nanoparticles are biocompatible, biodegradable, and suitable for targeted drug delivery.
2) Scope
This SOP applies to personnel involved in the preparation and characterization of protein-based nanoparticles in pharmaceutical or biomedical research settings.
3) Responsibilities
- Operators: Responsible for preparing protein-based nanoparticles as per the outlined procedure.
- QA: Ensures the nanoparticle formulations meet specifications for size, drug loading, and protein stability.
4) Procedure
4.1 Selection of Proteins and Therapeutic Agents
4.1.1 Protein Selection
- 4.1.1.1 Use proteins such as albumin, gelatin, or casein for nanoparticle formulation. Ensure the protein is biocompatible and stable under formulation conditions.
4.1.2 Drug Loading
- 4.1.2.1 Incorporate the therapeutic agent or peptide into the protein matrix during nanoparticle formation, optimizing drug loading and release properties.
4.2 Nanoparticle Preparation
4.2.1 Coacervation or Desolvation Method
- 4.2.1.1 Prepare protein nanoparticles using the coacervation or desolvation method, adjusting the pH and ionic strength to induce protein aggregation and nanoparticle formation.
4.3 Characterization
4.3.1 Particle Size and Zeta Potential
- 4.3.1.1 Measure the particle size and zeta potential using dynamic light scattering (DLS) to ensure uniform size distribution and charge stability.
4.3.2 Protein Stability Testing
- 4.3.2.1 Conduct protein stability testing to confirm the structural integrity of the protein after nanoparticle formation, using techniques like SDS-PAGE or circular dichroism.
4.4 Storage and Stability
4.4.1 Storage Conditions
- 4.4.1.1 Store the protein-based nanoparticles at 4°C in sealed containers to maintain stability and prevent protein degradation over time.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- SDS-PAGE: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis
6) Documents, if any
- Protein Nanoparticle Formulation Logbook
7) References, if any
- Protocols for protein-based nanoparticle formulation
8) SOP Version
Version 1.0
Annexure
Protein Nanoparticle Formulation Logbook Template
| Date | Batch Number | Protein Used | Therapeutic Agent | Particle Size | Stability Test Results | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Protein Name | Drug/Peptide Name | Size in nm | Pass/Fail | Operator Name | QA Name |