Standard Operating Procedure for Nanoparticle-Based Formulations for Cancer Therapy

1) Purpose

This SOP outlines the procedure for preparing nanoparticle-based formulations specifically for cancer therapy, focusing on encapsulation and delivery of chemotherapeutic agents to tumor cells.

2) Scope

This SOP applies to personnel responsible for preparing and optimizing nanoparticle-based drug formulations used in cancer treatment.

3) Responsibilities

• Operators: Responsible for the preparation of nanoparticle-based formulations for cancer therapy according to this SOP.
• QA: Ensures the nanoparticles meet the required quality, stability, and targeting specifications.

4) Procedure

4.1 Drug Encapsulation

4.1.1 Selection of Chemotherapeutic Agent

• 4.1.1.1 Select a chemotherapeutic drug (e.g., doxorubicin, paclitaxel) for encapsulation in the nanoparticle formulation.

4.1.2 Nanoparticle Formation

• 4.1.2.1 Prepare polymeric or lipid-based nanoparticles using the solvent evaporation or nanoprecipitation method, incorporating the chemotherapeutic agent during formulation.

4.2 Functionalization

4.2.1 Surface Modification

• 4.2.1.1 Functionalize the surface of the nanoparticles with targeting ligands (e.g., folic acid, antibodies) to enhance cancer cell-specific uptake.

4.3 Characterization

4.3.1 Particle Size and Drug Loading

• 4.3.1.1 Measure the particle size using DLS and calculate the drug loading efficiency using appropriate analytical techniques (e.g., HPLC).

4.4 In Vitro and In Vivo Testing

4.4.1 Cytotoxicity Studies

• 4.4.1.1 Conduct in vitro cytotoxicity studies on cancer cell lines to evaluate the efficacy of the formulation.

4.5 Storage of Nanoparticles

4.5.1 Storage Conditions

• 4.5.1.1 Store the nanoparticle formulations