Standard Operating Procedure for Incorporation of Targeting Ligands in Nanoparticle Formulations
1) Purpose
This SOP outlines the procedure for incorporating targeting ligands (e.g., antibodies, peptides, or folic acid) into nanoparticle formulations for targeted drug delivery applications.
2) Scope
This SOP applies to personnel involved in the preparation and functionalization of nanoparticles with targeting ligands for use in targeted drug delivery systems.
3) Responsibilities
- Operators: Responsible for incorporating targeting ligands into nanoparticles as per this SOP.
- QA: Ensures the nanoparticles meet the required specifications for ligand conjugation and targeting efficiency.
4) Procedure
4.1 Selection of Ligands
4.1.1 Ligand Selection
- 4.1.1.1 Select an appropriate targeting ligand based on the target tissue or cell type (e.g., antibodies for specific cancer cells, folic acid for receptor-mediated targeting).
- 4.1.1.2 Ensure the ligand is compatible with the nanoparticle surface and does not interfere with drug release.
4.2 Nanoparticle Functionalization
4.2.1 Ligand Conjugation
- 4.2.1.1 Conjugate the targeting ligand onto the surface of the nanoparticles using chemical coupling techniques (e.g., EDC/NHS chemistry for amine groups).
- 4.2.1.2 Stir the mixture under controlled conditions to ensure uniform attachment of the ligand to the nanoparticle surface.
4.3 Characterization of Functionalized Nanoparticles
4.3.1 Ligand Density
- 4.3.1.1 Quantify the ligand density on the nanoparticle surface using techniques such as UV-Vis spectroscopy or ELISA.
4.3.2 Targeting Efficiency
- 4.3.2.1 Conduct in vitro studies to assess the targeting efficiency of the nanoparticles, measuring binding affinity to target cells or receptors.
4.4 Particle Size and Stability Testing
4.4.1 Size and Stability
- 4.4.1.1 Measure particle size using dynamic light scattering (DLS) to ensure that ligand conjugation has not affected nanoparticle size.
- 4.4.1.2 Conduct stability studies to confirm that the functionalized nanoparticles remain stable in physiological conditions.
4.5 Storage of Functionalized Nanoparticles
4.5.1 Storage Conditions
- 4.5.1.1 Store the functionalized nanoparticles in sterile containers at 4°C to maintain stability and ligand activity.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- EDC/NHS: 1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide/N-hydroxysuccinimide
6) Documents, if any
- Targeting Ligand Functionalization Logbook
7) References, if any
- Protocols for ligand conjugation on nanoparticles
8) SOP Version
Version 1.0
Annexure
Targeting Ligand Functionalization Logbook Template
| Date | Batch Number | Ligand Type | Conjugation Method | Ligand Density | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Ligand Type | Method Used | Density (μg/mg) | Operator Name | QA Name |
