Rapid and scale-independent microfluidic manufacture of liposomes entrapping protein incorporating in-line purification and at-line size monitoring
[Display omitted] Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used microfluidics for the rapid and scale-independent manufacture of liposomes and have incorporated in-line purification and at-line monitoring of part...
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Published in | International journal of pharmaceutics Vol. 556; pp. 68 - 81 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Netherlands
Elsevier B.V
10.02.2019
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Subjects | |
Online Access | Get full text |
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Abstract | [Display omitted]
Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used microfluidics for the rapid and scale-independent manufacture of liposomes and have incorporated in-line purification and at-line monitoring of particle size. Using this process, we have manufactured a range of neutral and anionic liposomes incorporating protein. Factors investigated include the microfluidics operating parameters (flow rate ratio (FRR) and total flow rate (TFR)) and the liposome formulation. From these studies, we demonstrate that FRR is a key factor influencing liposome size, protein loading and release profiles. The liposome formulations produced by microfluidics offer high protein loading (20–35%) compared to production by sonication or extrusion (<5%). This high loading achieved by microfluidics results from the manufacturing process and is independent of lipid selection and concentration across the range tested. Using in-line purification and at-line size monitoring, we outline the normal operating range for effective production of size controlled (60–100 nm), homogenous (PDI <0.2) high load liposomes. This easy microfluidic process provides a translational manufacturing pathway for liposomes in a wide-range of applications. |
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AbstractList | Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used microfluidics for the rapid and scale-independent manufacture of liposomes and have incorporated in-line purification and at-line monitoring of particle size. Using this process, we have manufactured a range of neutral and anionic liposomes incorporating protein. Factors investigated include the microfluidics operating parameters (flow rate ratio (FRR) and total flow rate (TFR)) and the liposome formulation. From these studies, we demonstrate that FRR is a key factor influencing liposome size, protein loading and release profiles. The liposome formulations produced by microfluidics offer high protein loading (20-35%) compared to production by sonication or extrusion (<5%). This high loading achieved by microfluidics results from the manufacturing process and is independent of lipid selection and concentration across the range tested. Using in-line purification and at-line size monitoring, we outline the normal operating range for effective production of size controlled (60-100 nm), homogenous (PDI <0.2) high load liposomes. This easy microfluidic process provides a translational manufacturing pathway for liposomes in a wide-range of applications. Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used microfluidics for the rapid and scale-independent manufacture of liposomes and have incorporated in-line purification and at-line monitoring of particle size. Using this process, we have manufactured a range of neutral and anionic liposomes incorporating protein. Factors investigated include the microfluidics operating parameters (flow rate ratio (FRR) and total flow rate (TFR)) and the liposome formulation. From these studies, we demonstrate that FRR is a key factor influencing liposome size, protein loading and release profiles. The liposome formulations produced by microfluidics offer high protein loading (20-35%) compared to production by sonication or extrusion (<5%). This high loading achieved by microfluidics results from the manufacturing process and is independent of lipid selection and concentration across the range tested. Using in-line purification and at-line size monitoring, we outline the normal operating range for effective production of size controlled (60-100 nm), homogenous (PDI <0.2) high load liposomes. This easy microfluidic process provides a translational manufacturing pathway for liposomes in a wide-range of applications. [Display omitted] Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used microfluidics for the rapid and scale-independent manufacture of liposomes and have incorporated in-line purification and at-line monitoring of particle size. Using this process, we have manufactured a range of neutral and anionic liposomes incorporating protein. Factors investigated include the microfluidics operating parameters (flow rate ratio (FRR) and total flow rate (TFR)) and the liposome formulation. From these studies, we demonstrate that FRR is a key factor influencing liposome size, protein loading and release profiles. The liposome formulations produced by microfluidics offer high protein loading (20–35%) compared to production by sonication or extrusion (<5%). This high loading achieved by microfluidics results from the manufacturing process and is independent of lipid selection and concentration across the range tested. Using in-line purification and at-line size monitoring, we outline the normal operating range for effective production of size controlled (60–100 nm), homogenous (PDI <0.2) high load liposomes. This easy microfluidic process provides a translational manufacturing pathway for liposomes in a wide-range of applications. |
Author | Forbes, Neil Edwards, Darren P. Perrie, Yvonne Szita, Nicolas Briuglia, Maria L. Horst, Joop H. ter Hussain, Maryam T. |
Author_xml | – sequence: 1 givenname: Neil surname: Forbes fullname: Forbes, Neil organization: Strathclyde Institute of Pharmacy and Biomedical Sciences, 161 Cathedral St, University of Strathclyde, Glasgow, Scotland, G4 0RE, United Kingdom – sequence: 2 givenname: Maryam T. surname: Hussain fullname: Hussain, Maryam T. organization: Strathclyde Institute of Pharmacy and Biomedical Sciences, 161 Cathedral St, University of Strathclyde, Glasgow, Scotland, G4 0RE, United Kingdom – sequence: 3 givenname: Maria L. surname: Briuglia fullname: Briuglia, Maria L. organization: Strathclyde Institute of Pharmacy and Biomedical Sciences, Technology and Innovation Centre, University of Strathclyde, 99 George St, Glasgow, G1 1RD, United Kingdom – sequence: 4 givenname: Darren P. surname: Edwards fullname: Edwards, Darren P. organization: Drug Discovery Unit, School of Life and Health Sciences, University of Dundee, Dow St, Dundee, Scotland DD1 5EH, United Kingdom – sequence: 5 givenname: Joop H. ter surname: Horst fullname: Horst, Joop H. ter organization: Strathclyde Institute of Pharmacy and Biomedical Sciences, Technology and Innovation Centre, University of Strathclyde, 99 George St, Glasgow, G1 1RD, United Kingdom – sequence: 6 givenname: Nicolas surname: Szita fullname: Szita, Nicolas organization: Department of Biochemical Engineering, University College London, London WC1H 0AH, United Kingdom – sequence: 7 givenname: Yvonne orcidid: 0000-0001-8497-2541 surname: Perrie fullname: Perrie, Yvonne email: yvonne.perrie@strath.ac.uk organization: Strathclyde Institute of Pharmacy and Biomedical Sciences, 161 Cathedral St, University of Strathclyde, Glasgow, Scotland, G4 0RE, United Kingdom |
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Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used... Within this paper we present work that has the ability to de-risk the translation of liposomes from bench to the clinic. We have used microfluidics for the... |
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SubjectTerms | Continuous Formulation Liposomes Manufacture Microfluidics Protein Scale-independent |
Title | Rapid and scale-independent microfluidic manufacture of liposomes entrapping protein incorporating in-line purification and at-line size monitoring |
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