Standard Operating Procedure for Incorporation of Bioactive Molecules in Nanoparticle-Based Formulations

1) Purpose

This SOP outlines the procedure for incorporating bioactive molecules, such as proteins, peptides, or small molecules, into nanoparticle formulations for targeted drug delivery or therapeutic applications.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of nanoparticles loaded with bioactive molecules for various biomedical applications.

3) Responsibilities

• Operators: Responsible for incorporating bioactive molecules into nanoparticle formulations following this SOP.
• QA: Ensures the nanoparticles meet specifications for bioactivity, size, and stability.

4) Procedure

4.1 Selection of Bioactive Molecule

4.1.1 Compatibility Check

• 4.1.1.1 Select bioactive molecules, such as proteins or peptides, that are stable and compatible with the nanoparticle matrix (e.g., PLGA or chitosan).

4.2 Nanoparticle Preparation

4.2.1 Solvent Evaporation or Nanoprecipitation

• 4.2.1.1 Use solvent evaporation or nanoprecipitation techniques to prepare nanoparticles, ensuring the bioactive molecule is incorporated into the formulation.

4.3 Bioactive Molecule Loading

4.3.1 Incorporation Techniques

• 4.3.1.1 Incorporate the bioactive molecule during nanoparticle formation or post-formulation by adsorption or encapsulation techniques.

4.4 Characterization

4.4.1 Particle Size Measurement

• 4.4.1.1 Measure the particle size using dynamic light scattering (DLS) to ensure the nanoparticles are within the desired size range (100–300 nm).

4.4.2 Bioactivity Assay

• 4.4.2.1 Perform a bioactivity assay to confirm the activity of the bioactive molecule has been