Standard Operating Procedure for Incorporation of Targeting Ligands in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for incorporating targeting ligands, such as antibodies or peptides, into nanoparticle formulations to improve the specificity and efficacy of drug delivery by targeting diseased cells or tissues.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of targeted nanoparticle formulations for use in drug delivery and therapeutic applications.

3) Responsibilities

• Operators: Responsible for incorporating targeting ligands into nanoparticle formulations following the outlined procedure.
• QA: Ensures that the targeted nanoparticles meet the required specifications for ligand attachment and targeting efficacy.

4) Procedure

4.1 Selection of Targeting Ligands

4.1.1 Ligand Types

• 4.1.1.1 Choose appropriate targeting ligands such as antibodies (e.g., anti-EGFR), peptides (e.g., RGD peptide), or aptamers that bind specifically to receptors on diseased cells or tissues.

4.1.2 Ligand Conjugation

• 4.1.2.1 Use chemical or physical conjugation techniques (e.g., EDC/NHS coupling, thiol-maleimide reaction) to attach the targeting ligands to the nanoparticle surface.

4.2 Nanoparticle Preparation

4.2.1 Ligand-Conjugated Nanoparticles

• 4.2.1.1 Prepare ligand-conjugated nanoparticles by adding the targeting ligands to pre-formed nanoparticles and allowing the conjugation reaction to occur under controlled conditions.

4.3 Characterization

4.3.1 Ligand Density and Activity

• 4.3.1.1 Quantify the number of ligands conjugated to the nanoparticles using techniques such as ELISA