Standard Operating Procedure for Nanoparticle-Based Formulations for Cancer Therapy
1) Purpose
This SOP outlines the procedure for formulating nanoparticles designed for cancer therapy. These nanoparticles are used to deliver chemotherapeutic agents directly to cancer cells, improving efficacy and reducing systemic side effects.
2) Scope
This SOP applies to personnel involved in the preparation, characterization, and testing of nanoparticle formulations intended for cancer therapy in pharmaceutical or research settings.
3) Responsibilities
- Operators: Responsible for preparing nanoparticle-based cancer therapy formulations following this SOP.
- QA: Ensures that formulations meet specifications for drug loading, particle size, and targeting efficiency.
4) Procedure
4.1 Selection of Polymers and Drugs
4.1.1 Polymer Selection
- 4.1.1.1 Select biocompatible and biodegradable polymers such as PLGA or PEGylated lipids for nanoparticle formulation, ensuring minimal toxicity and prolonged circulation in the bloodstream.
4.1.2 Drug Loading
- 4.1.2.1 Incorporate the chemotherapeutic agent (e.g., doxorubicin, paclitaxel) into the nanoparticles during the preparation process, optimizing drug loading for efficient delivery to cancer cells.
4.2 Nanoparticle Preparation
4.2.1 Solvent Evaporation or Nanoprecipitation Method
- 4.2.1.1 Use solvent evaporation or nanoprecipitation methods to prepare nanoparticles with a particle size between 100 and 200 nm, suitable for enhanced permeability and retention (EPR) effect in tumors.
4.3 Targeting and Surface Modification
4.3.1 Surface Functionalization
- 4.3.1.1 Modify the nanoparticle surface with targeting ligands such as antibodies or peptides (e.g., folic acid) to improve selective uptake by cancer cells.
4.4 Characterization
4.4.1 Particle Size and Drug Loading Efficiency
- 4.4.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate the drug loading efficiency using high-performance liquid chromatography (HPLC).
4.4.2 In Vitro Cytotoxicity Testing
- 4.4.2.1 Perform in vitro cytotoxicity assays on cancer cell lines to evaluate the efficacy of the nanoparticle formulation in killing cancer cells.
4.5 Storage
4.5.1 Storage Conditions
- 4.5.1.1 Store the nanoparticle formulations in sterile, sealed containers at 4°C to maintain stability and prevent degradation of the chemotherapeutic agent.
5) Abbreviations, if any
- PLGA: Poly(lactic-co-glycolic acid)
- PEG: Polyethylene Glycol
- DLS: Dynamic Light Scattering
- HPLC: High-Performance Liquid Chromatography
6) Documents, if any
- Cancer Therapy Nanoparticle Formulation Logbook
7) References, if any
- Protocols for nanoparticle-based cancer therapy formulations
8) SOP Version
Version 1.0
Annexure
Cancer Therapy Nanoparticle Formulation Logbook Template
| Date | Batch Number | Polymer Type | Targeting Ligand | Particle Size | Drug Loading Efficiency | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer Type | Ligand Used | Size in nm | Efficiency (%) | Operator Name | QA Name |