SOP for Incorporation of Bioactive Molecules in Nanoparticle-Based Formulations

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

preserved during the formulation process.

4.5 Stability Testing

4.5.1 Stability Assay

4.5.1.1 Conduct stability studies to ensure the nanoparticles maintain their integrity and bioactivity during storage.

4.6 Storage

4.6.1 Storage Conditions

4.6.1.1 Store the nanoparticles containing bioactive molecules in sterile containers at 4°C or room temperature, depending on the stability of the bioactive molecule.

5) Abbreviations, if any

DLS: Dynamic Light Scattering

6) Documents, if any

Bioactive Molecule Nanoparticle Formulation Logbook

7) References, if any

Protocols for incorporating bioactive molecules in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Bioactive Molecule Nanoparticle Formulation Logbook Template


  
    Date
    Batch Number
    Bioactive Molecule
    Particle Size
    Bioactivity Results
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Molecule Name
    Size in nm
    Pass/Fail
    Operator Name
    QA Name

Date	Batch Number	Bioactive Molecule	Particle Size	Bioactivity Results	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Molecule Name	Size in nm	Pass/Fail	Operator Name	QA Name