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 at 4°C in sterile containers.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- HPLC: High-Performance Liquid Chromatography
6) Documents, if any
- Cancer Therapy Nanoparticle Preparation Logbook
7) References, if any
- Protocols for nanoparticle formulations for cancer therapy
8) SOP Version
Version 1.0
Annexure
Cancer Therapy Nanoparticle Preparation Logbook Template
| Date | Batch Number | Drug Encapsulated | Particle Size | Encapsulation Efficiency | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Drug Name | Size in nm | % Encapsulation | Operator Name | QA Name |
