Standard Operating Procedure for Formulation of Protein-Based Nanoparticles
1) Purpose
This SOP outlines the procedure for the preparation of protein-based nanoparticles, which are widely used for drug delivery due to their biocompatibility, biodegradability, and ability to encapsulate both hydrophilic and hydrophobic drugs.
2) Scope
This SOP applies to personnel involved in the preparation of protein-based nanoparticles for various pharmaceutical applications.
3) Responsibilities
- Operators: Responsible for the accurate preparation of protein-based nanoparticles following the outlined protocol.
- QA: Ensures the prepared nanoparticles meet quality and particle size specifications.
4) Procedure
4.1 Selection of Protein
4.1.1 Protein Types
- 4.1.1.1 Select appropriate proteins such as albumin, gelatin, or casein, based on the desired application and drug to be encapsulated.
4.2 Nanoparticle Formation
4.2.1 Coacervation Method
- 4.2.1.1 Prepare protein nanoparticles using the coacervation method. Dissolve the protein in water and add a coacervating agent under controlled conditions to induce nanoparticle formation.
4.3 Drug Loading
4.3.1 Incorporation of Drug
- 4.3.1.1 Incorporate the drug into the protein matrix during or after the nanoparticle formation, depending on the drug’s properties.
4.4 Particle Size and Stability Testing
4.4.1 Dynamic Light Scattering (DLS)
- 4.4.1.1 Measure the particle size using DLS to ensure the nanoparticles are in the desired size range (100–300 nm).
4.4.2 Stability Testing
- 4.4.2.1 Conduct stability tests to confirm that the protein-based nanoparticles are stable under physiological conditions and do not aggregate.
4.5 Storage
4.5.1 Storage Conditions
- 4.5.1.1 Store the protein-based nanoparticles in sealed containers at 4°C or room temperature, depending on stability data.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
6) Documents, if any
- Protein-Based Nanoparticle Formulation Logbook
7) References, if any
- Protocols for the formulation of protein-based nanoparticles
8) SOP Version
Version 1.0
Annexure
Protein-Based Nanoparticle Formulation Logbook Template
| Date | Batch Number | Protein Type | Particle Size | Stability Results | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Protein Type | Size in nm | Pass/Fail | Operator Name | QA Name |
