SOP for Formulation of Protein-Based Nanoparticles

Standard Operating Procedure for Formulation of Protein-Based Nanoparticles

1) Purpose

This SOP outlines the procedure for formulating protein-based nanoparticles, which are used for the delivery of peptides, proteins, or therapeutic agents. Protein-based nanoparticles are biocompatible, biodegradable, and suitable for targeted drug delivery.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of protein-based nanoparticles in pharmaceutical or biomedical research settings.

3) Responsibilities

Operators: Responsible for preparing protein-based nanoparticles as per the outlined procedure.
QA: Ensures the nanoparticle formulations meet specifications for size, drug loading, and protein stability.

4) Procedure

4.1 Selection of Proteins and Therapeutic Agents

4.1.1 Protein Selection

4.1.1.1 Use proteins such as albumin, gelatin, or casein for nanoparticle formulation. Ensure the protein is biocompatible and stable under formulation conditions.

4.1.2 Drug Loading

4.1.2.1 Incorporate the therapeutic agent or peptide into the protein matrix during nanoparticle formation, optimizing drug loading and release properties.

4.2 Nanoparticle Preparation

4.2.1 Coacervation or Desolvation Method

4.2.1.1 Prepare protein nanoparticles using the coacervation or desolvation method, adjusting the pH and ionic strength to induce protein aggregation and nanoparticle formation.

4.3 Characterization

4.3.1 Particle Size and Zeta Potential

4.3.1.1 Measure the particle size and zeta potential using dynamic light scattering (DLS) to ensure uniform size distribution and charge stability.

4.3.2 Protein Stability Testing

4.3.2.1 Conduct protein stability

testing to confirm the structural integrity of the protein after nanoparticle formation, using techniques like SDS-PAGE or circular dichroism.

4.4 Storage and Stability

4.4.1 Storage Conditions

4.4.1.1 Store the protein-based nanoparticles at 4°C in sealed containers to maintain stability and prevent protein degradation over time.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
SDS-PAGE: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis

6) Documents, if any

Protein Nanoparticle Formulation Logbook

7) References, if any

Protocols for protein-based nanoparticle formulation

8) SOP Version

Version 1.0

Annexure

Protein Nanoparticle Formulation Logbook Template


  
    Date
    Batch Number
    Protein Used
    Therapeutic Agent
    Particle Size
    Stability Test Results
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Protein Name
    Drug/Peptide Name
    Size in nm
    Pass/Fail
    Operator Name
    QA Name

Date	Batch Number	Protein Used	Therapeutic Agent	Particle Size	Stability Test Results	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Protein Name	Drug/Peptide Name	Size in nm	Pass/Fail	Operator Name	QA Name