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Can We Simplify Liposome Manufacturing Using a Complex DoE Approach?

Sarah Lindsay¹, Olympia Tumolva², Tatsiana Khamiakova²

¹Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, UK.

|September 28, 2024

Summary

This summary is machine-generated.

Microfluidic liposome production allows tunable liposome characteristics by controlling formulation and production parameters. This study optimized liposome size and polydispersity using design of experiments and machine learning.

Keywords:

design of experiments liposomes machine learning (ML)manufacturing microfluidics

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Area of Science:

Pharmaceutical Sciences
Chemical Engineering
Biotechnology

Background:

Microfluidic production offers a scalable method for liposome synthesis.
Liposome characteristics are influenced by formulation and process parameters.
Optimizing these parameters is crucial for clinical translation.

Purpose of the Study:

To investigate the impact of total flow rate (TFR), flow rate ratio (FRR), lipid concentration, solvent selection, aqueous buffer, and production temperature on liposome attributes.
To establish in-process controls for critical quality attributes of liposomes.
To apply design of experiments (DoE) and machine learning for process optimization.

Main Methods:

Utilized microfluidic technology for liposome production.
Employed a design of experiments (DoE) approach to systematically vary key parameters.
Integrated machine learning algorithms to analyze complex relationships between parameters and outcomes.
Investigated factors including TFR, FRR, lipid concentration, solvent, buffer, and temperature.

Main Results:

Liposome size and polydispersity were significantly affected by TFR and FRR.
Lipid type, concentration, and solvent selection also demonstrably influenced liposome attributes.
Demonstrated the ability to control liposome critical quality attributes through in-process adjustments.

Conclusions:

Microfluidic liposome production enables precise control over liposome size and polydispersity.
A comprehensive understanding of formulation and process parameters is essential for manufacturing.
This approach facilitates the efficient translation of liposomal formulations to clinical applications.