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