SOP for Nanoparticle-Based Formulations for Cancer Therapy

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

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