期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 582, 期 -, 页码 -出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2020.119266
关键词
Microfluidics; Manufacture; Liposomes; Nanomedicines; Continuous; Scale-independent
资金
- Strathclyde University
- EPSRC Centre for Innovative Manufacturing in Emergent Therapies (EPSRC) [EP/I033270/1]
- Microsun [NFC-01]
- PHA-ST-TRAIN-VAC (European Commission Project Leveraging Pharmaceutical Sciences and Structural Biology Training to Develop 21st Century Vaccines) (H2020-MSCA-ITN-2015 grant) [675370]
- NanoPrime
- an EPSRC
- EPSRC [EP/L022494/1]
- University of Nottingham
- University of Nottingham initiative [EP/R025282/1]
- EPSRC [EP/I033270/1, EP/R025282/1, EP/P006485/1] Funding Source: UKRI
- Marie Curie Actions (MSCA) [675370] Funding Source: Marie Curie Actions (MSCA)
- Engineering and Physical Sciences Research Council [EP/N009126/1, EP/P006485/1] Funding Source: researchfish
Nanomedicines are well recognised for their ability to improve therapeutic outcomes. Yet, due to their complexity, nanomedicines are challenging and costly to produce using traditional manufacturing methods. For nanomedicines to be widely exploited, new manufacturing technologies must be adopted to reduce development costs and provide a consistent product. Within this study, we investigate microfluidic manufacture of nanomedicines. Using protein-loaded liposomes as a case study, we manufacture liposomes with tightly defined physico-chemical attributes (size, PDI, protein loading and release) from small-scale (1 mL) through to GMP volume production (200 mL/min). To achieve this, we investigate two different laminar flow microfluidic cartridge designs (based on a staggered herringbone design and a novel toroidal mixer design); for the first time we demonstrate the use of a new microfluidic cartridge design which delivers seamless scale-up production from bench-scale (12 mL/min) through GMP production requirements of over 20 L/h using the same standardised normal operating parameters. We also outline the application of tangential flow filtration for down-stream processing and high product yield. This work confirms that defined liposome products can be manufactured rapidly and reproducibly using a scale-independent production process, thereby de-risking the journey from bench to approved product.
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