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Manufacturing Considerations for the Development of Lipid Nanoparticles Using Microfluidics
Carla B Roces1, Gustavo Lou1, Nikita Jain2
1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.
Pharmaceutics
|November 18, 2020
Summary
Microfluidics enables scalable manufacture of lipid nanoparticles (LNPs) for RNA delivery. Key parameters like flow rate ratio and total flow rate significantly impact LNP size and characteristics, guiding efficient LNP system development.
Area of Science:
- Biotechnology and Pharmaceutical Sciences
- Nanotechnology for Drug Delivery
- Chemical and Biomolecular Engineering
Background:
- Lipid nanoparticles (LNPs) are crucial for RNA delivery, with many in clinical development for vaccines and therapeutics.
- Microfluidics presents advantages for LNP manufacturing, including scalability, reproducibility, and rapid preparation.
Purpose of the Study:
- To evaluate critical operating and formulation parameters for developing lipid nanoparticles (LNPs) using microfluidics.
- To understand how parameters like flow rate ratio (FRR) and total flow rate (TFR) influence LNP physicochemical properties.
Main Methods:
- Investigated the impact of varying FRR and TFR on LNP characteristics.
- Assessed the influence of different amino lipids (cationic and ionizable), buffer systems (citrate and TRIS), and nucleic acid payloads (PolyA, ssDNA, mRNA).
- Utilized microfluidics for controlled LNP synthesis and characterization.
Main Results:
- Increasing TFR or FRR led to a decrease in LNP particle size.
- Amino lipid choice, buffer pH, and nucleic acid payload type affected LNP characteristics.
- Achieved high encapsulation efficiency (>90%) and produced LNPs below 100 nm with low polydispersity (≤0.25).
Conclusions:
- Microfluidic parameters, including FRR and TFR, are key determinants of LNP size and properties.
- Formulation components significantly impact LNP characteristics, necessitating careful selection.
- This study provides a guide for the rational design and scalable microfluidic manufacturing of LNP systems for RNA delivery.
