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Liposomes produced in a pilot scale: production, purification and efficiency aspects
Andreas Wagner1, Karola Vorauer-Uhl, Hermann Katinger
1Polymun Scientific, Immunbiologische Forschung GmbH, Vienna, Austria. wagner@edv2.boku.ac.at
Summary
A new crossflow injection technique enables scalable liposome preparation for large proteins. This method ensures consistent quality and efficient encapsulation, advancing protein delivery systems.
Area of Science:
- Biotechnology
- Materials Science
- Pharmaceutical Sciences
Background:
- Liposomes are crucial drug delivery vehicles, but encapsulating large proteins remains challenging.
- Existing liposome preparation methods often lack scalability and efficiency for protein encapsulation.
Purpose of the Study:
- To present a novel, scalable liposomal preparation technique for efficient large protein entrapment.
- To detail a three-step production process utilizing a specifically designed crossflow injection module.
Main Methods:
- Development of a crossflow injection module based on ethanol injection principles.
- A three-step process: protein encapsulation, continuous crossflow filtration for separation, and additional filtration for retrieval.
- Comparison of consecutive production lots based on defined quality criteria.
Main Results:
- The crossflow injection technique allows for scalable liposome manufacture irrespective of production volume.
- The process effectively encapsulates large proteins, demonstrated by the retrieval of rh-Cu/Zn-SOD.
- Consistent quality was observed across consecutive production lots.
Conclusions:
- The developed crossflow injection technique offers a scalable and efficient method for liposome preparation with large proteins.
- This advancement has significant implications for protein-based therapeutics and delivery systems.
- The technique ensures reproducible quality control for liposomal protein formulations.