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Scalable Manufacturing Processes for Solid Lipid Nanoparticles.

Giulia Anderluzzi1, Gustavo Lou1, Yang Su2

  • 1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow G4 0RE, Scotland.

Pharmaceutical Nanotechnology
|December 17, 2019
PubMed
Summary
This summary is machine-generated.

This study presents a scalable manufacturing process for solid lipid nanoparticles (SLNs) using microfluidization. The optimized process enables high-throughput production, purification, and at-line monitoring of protein-loaded SLNs.

Keywords:
High-throughput manufacturingmicrofluidicsmicrofluidizer processorprotein deliverysolid lipid nanoparticlestangential flow filtration.

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Area of Science:

  • Nanotechnology
  • Materials Science
  • Biotechnology

Background:

  • Solid lipid nanoparticles (SLNs) are promising drug delivery systems.
  • Effective and scalable manufacturing processes for SLNs remain a challenge.

Purpose of the Study:

  • To develop and optimize a high-throughput, scalable manufacturing process for SLNs.
  • To incorporate at-line monitoring for process control and product validation.

Main Methods:

  • SLNs formulated with tristearin and a phospholipid-PEG conjugate.
  • Manufactured using a Microfluidizer processor at optimized pressures (20,000-30,000 psi) and cycles (1-5).
  • Purified via tangential flow filtration with at-line particle size monitoring.

Main Results:

  • Effective SLN manufacturing achieved at 20,000 psi with 2 passes.
  • Purification and removal of non-entrapped protein completed in 12 diafiltration cycles.
  • At-line monitoring enabled rapid process control and product validation.

Conclusions:

  • A scalable microfluidization process for manufacturing protein-loaded SLNs was demonstrated.
  • The process allows for controlled Pegylation levels (1% and 16%).
  • At-line monitoring facilitates efficient production and quality control of SLNs.