Standard Operating Procedure for Preparation of Polymer-Based Nanoparticles

1) Purpose

This SOP describes the process for preparing polymer-based nanoparticles, commonly used for drug delivery and other biomedical applications. It aims to ensure a consistent and high-quality preparation process.

2) Scope

This SOP applies to laboratory personnel involved in the preparation and processing of polymer-based nanoparticles in the research or production setting.

3) Responsibilities

• Operators: Responsible for the accurate preparation and processing of polymer-based nanoparticles according to this SOP.
• QA: Ensures compliance with protocols and verifies the quality of prepared nanoparticles.

4) Procedure

4.1 Polymer Preparation

4.1.1 Polymer Selection

• 4.1.1.1 Select appropriate polymers (e.g., PLGA, PEG) based on the desired properties of the nanoparticles (e.g., size, degradation rate).
• 4.1.1.2 Verify the quality of the polymer by reviewing certificates of analysis and performing any necessary pre-processing checks.

4.1.2 Polymer Dissolution

• 4.1.2.1 Dissolve the polymer in an appropriate solvent (e.g., acetone or ethanol) under continuous stirring until fully solubilized.
• 4.1.2.2 If heating is required, ensure the temperature does not exceed the polymer’s thermal stability.

4.2 Nanoparticle Formation

4.2.1 Emulsification

• 4.2.1.1 Slowly add the polymer solution to an aqueous phase containing stabilizers under high-speed homogenization to form an emulsion.
• 4.2.1.2 Continue mixing for 10–15 minutes to stabilize the emulsion.

4.2.2 Solvent Evaporation

• 4.2.2.1 Allow the solvent to evaporate under reduced