Standard Operating Procedure for Incorporation of Peptides in Nanoparticle-Based Formulations

1) Purpose

This SOP outlines the procedure for incorporating peptides into nanoparticle formulations. Peptides offer unique advantages for drug delivery, including targeted therapy, enhanced bioavailability, and controlled release.

2) Scope

This SOP applies to personnel responsible for incorporating peptides into nanoparticles for pharmaceutical and drug delivery applications.

3) Responsibilities

• Operators: Responsible for incorporating peptides into the nanoparticle formulations as per this SOP.
• QA: Ensures that the peptide-nanoparticle formulations meet required specifications for stability, particle size, and peptide content.

4) Procedure

4.1 Peptide Selection

4.1.1 Selection of Peptides

• 4.1.1.1 Select the appropriate peptide based on the target application, ensuring compatibility with the nanoparticle matrix and stability during formulation.

4.2 Nanoparticle Formation

4.2.1 Solvent Evaporation or Nanoprecipitation

• 4.2.1.1 Form nanoparticles using solvent evaporation or nanoprecipitation methods. Dissolve the polymer or lipid in an organic solvent and mix with an aqueous phase containing the peptide.
• 4.2.1.2 Ensure the peptides are uniformly dispersed within the nanoparticle matrix.

4.3 Peptide Loading

4.3.1 Peptide Incorporation

• 4.3.1.1 Load the peptide during nanoparticle formation by covalent attachment, physical adsorption, or encapsulation, depending on the formulation method.

4.4 Particle Size and Peptide Stability Testing

4.4.1 Dynamic Light Scattering (DLS)

• 4.4.1.1 Measure the particle size using DLS to ensure the nanoparticles are in the required size range (100–200 nm).

4.4.2 Peptide Integrity

• 4.4.2.1 Analyze the peptide integrity using high-performance liquid chromatography (HPLC) to ensure no degradation occurred during formulation.

4.5 Storage

4.5.1 Storage Conditions

• 4.5.1.1 Store the peptide-loaded nanoparticles at 4°C in sterile containers to preserve peptide stability and formulation integrity.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• HPLC: High-Performance Liquid Chromatography

6) Documents, if any

• Peptide-Nanoparticle Formulation Logbook

7) References, if any

• Protocols for peptide incorporation in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Peptide-Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Peptide Type
    
Particle Size
    
Peptide Stability
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Peptide Type
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name