Nanofibre scale-up and industrial validation - Industrial Biotechnology Catalyst Translation and Industrial Research Awards
Lead Research Organisation:
University College London
Department Name: Biochemical Engineering
Abstract
Biopharmaceuticals are an increasingly important sector of the pharmaceutical industry, over one third of all drugs now in development are biopharmaceuticals and they make up half of the top 10 revenue blockbusters. It typically takes over 10 years and $800 million to develop a new drug. Global demand for cheaper biotherapeutics, which represent many of the new tools in the fight against diseases such as cancer and neurodegenerative conditions, drives the need for a reduction in manufacturing costs. A significant proportion of current costs arise from the purification technologies now used to ensure the safety and efficacy of these treatments. This project aims to build on existing collaborations between Puridify, an SME with a novel nanofibre purification technology, and University College London (UCL), a world leading research organisation for the development of industrial bioprocessing technologies. The successful award of this project lead by Puridify and supported by shadow industrial partners will see the development and commercialisation of innovative bioprocessing platform technologies allowing the cost effective manufacture of a wide range of existing and new products.
The project will accelerate development of Puridify's novel platform downstream bioprocessing technologies towards commercial activity. The technologies increased productivity will provide an efficient manufacturing route to both new and existing products benefiting society and the sector as a whole by reducing costs and enabling the economic manufacture of next generation biotherapeutics. Using new processing technologies, theory and modelling, this integrated Industrial Research and Development project will accelerate the commercialisation of this technology by bringing together key academic and business components of the UK Industrial Biotechnology community.
The project will accelerate development of Puridify's novel platform downstream bioprocessing technologies towards commercial activity. The technologies increased productivity will provide an efficient manufacturing route to both new and existing products benefiting society and the sector as a whole by reducing costs and enabling the economic manufacture of next generation biotherapeutics. Using new processing technologies, theory and modelling, this integrated Industrial Research and Development project will accelerate the commercialisation of this technology by bringing together key academic and business components of the UK Industrial Biotechnology community.
Publications
Dods SR
(2015)
Fabricating electrospun cellulose nanofibre adsorbents for ion-exchange chromatography.
in Journal of chromatography. A
Hardick O
(2015)
Nanofiber adsorbents for high productivity continuous downstream processing.
in Journal of biotechnology
Ruscic J
(2019)
Lentiviral Vector Purification Using Nanofiber Ion-Exchange Chromatography.
in Molecular therapy. Methods & clinical development
Turnbull J
(2019)
Cover Image, Volume 116, Number 7, July 2019
in Biotechnology and Bioengineering
Turnbull J
(2019)
Adenovirus 5 recovery using nanofiber ion-exchange adsorbents.
in Biotechnology and bioengineering
| Description | Biopharmaceuticals are an increasingly important sector of the pharmaceutical industry, over one third of all drugs now in development are biopharmaceuticals and they make up half of the top 10 revenue blockbusters. It typically takes over 10years and $800 million to develop a new drug. Global demand for cheaper biotherapeutics, which represent many of the new tools in the fight against diseases such as cancer and neurodegenerative conditions, drives the need for a reduction in manufacturing costs. A significant proportion of current costs arise from the purification technologies now used to ensure the safety and efficacy of these treatments. This project aims to build on existing collaborations between Puridify, an SME with a novel nanofibre purification technology, and University College London (UCL), a world leading research organisation for the development of industrial bioprocessing technologies. The successful award of this project lead by Puridify and supported by shadow industrial partners will see the development and commercialisation of innovative bioprocessing platform technologies allowing the cost effective manufacture of a wide range of existing and new products. The project will accelerate development of Puridify's novel platform downstream bioprocessing technologies towards commercial activity. The technologies increased productivity will provide an efficient manufacturing route to both new and existing products benefiting society and the sector as a whole by reducing costs and enabling the economic manufacture of next generation biotherapeutics. Using new processing technologies, theory and modelling, this integrated Industria lResearch and Development project will accelerate the commercialisation of this technology by bringing together key academic and business components of the UK Industrial Biotechnology community. |
| Exploitation Route | Global demand for cheaper biotherapeutics, which represent many of the new tools in the fight against diseases such as cancer and neurodegenerative conditions, drives the need for a reduction in manufacturing costs. A significant proportion of current costs arise from the purification technologies now used to ensure the safety and efficacy of these treatments. This project aims to build on existing collaborations between Puridify, an SME with a novel nanofibre purification technology, and University College London (UCL), a world leading research organisation for the development of industrial bioprocessing technologies. The successful award of this project lead by Puridify and supported by shadow industrial partners will see the development and commercialisation of innovative bioprocessing platform technologies allowing the cost effective manufacture of a wide range of existing and new products. |
| Sectors | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| URL | https://www.genengnews.com/topics/bioprocessing/ge-healthcare-acquires-uks-puridify/ |
| Description | Antibodies are used as therapeutics to treat conditions from cancer to cardiovascular disease and can now be manufactured in the lab, but the process can be inefficient. Nanofibres are being used in medical settings including in the manufacture of implants, as tissue replacement, and in wound dressing. Professor Daniel Bracewell at UCL in collaboration with Professor Bob Stevens at STFC Rutherford Appleton laboratories developed novel nanofibres that could be used to enhance the purification of therapeutic antibodies. The manufacture of antibodies for therapeutic use requires their separation from the crude production mixture. Commonly, chromatography is used, and the antibodies separated by attaching to a beaded resin through a process called adsorption. The UCL/Rutherford Appleton team set about designing a new chromatography process that would intensify the separation process and increase productivity. They created cellulose nanofibre materials with high surface area to provide high binding capacity and that allowed directed transfer of the antibodies from the mixture to the fibres. After patenting the materials, Oliver Hardwick, a doctoral student at UCL at the time, established a spin-out company Puridify, to develop the product further. By 2016, the company had 14 scientists at their site at Stevenage and 4 postdoctoral researchers working with Professor Bracewell at UCL via Innovate UK funding. Puridify has won six Innovate UK Awards and in 2015, Bracewell and Hardick were finalists in the BBSRC Innovator of the year competition. The company has since been acquired by GE Healthcare and the nanofibre product marketed as 'FibroPrismA'. Puridify's Fibro technology platform (commercially available as Fibro PrismA) improves efficiency, by speeding up the separation process. These faster work rates, means small disposable units can replace much larger cumbersome beaded resin chromatography. Additionally, the technology allows a manufacturer to switch more easily between different biopharmaceutical products. This cost effective solution means that manufacture of advanced treatments in low- and middle-income countries is more feasible. UCL has already applied the nanofibre separation technology to other therapeutic products such as the viral vectors used in gene therapy and vaccine technologies, improving the yield of active viral vector product over other methods. Sale of spin-out company (Puridify) to GE Healthcare. https://www.genewsroom.com/press-releases/ge-healthcare-acquires-bioprocessing-start-puridify https://www.gov.uk/government/case-studies/success-story-puridify-heralds-new-generation-of-biotherapeutics https://www.gov.uk/government/news/uk-bioprocessing-firm-acquired-by-ge-healthcare |
| First Year Of Impact | 2017 |
| Sector | Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology |
| Impact Types | Economic |
| Description | Development and optimisation of downstream processing for next generation biotherapeutics |
| Amount | £363,241 (GBP) |
| Funding ID | EP/N013395/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 01/2016 |
| End | 09/2017 |
| Description | The Future Vaccine Manufacturing Research Hub (Vax-Hub) |
| Amount | £6,968,180 (GBP) |
| Funding ID | EP/R013756/1 |
| Organisation | Engineering and Physical Sciences Research Council (EPSRC) |
| Sector | Public |
| Country | United Kingdom |
| Start | 04/2018 |
| End | 03/2021 |
| Title | CHROMATOGRAPHY MEDIUM |
| Description | The present invention provides a chromatography medium comprising one or more electrospun polymer nanofibres which in use form a stationary phase comprising a plurality of pores through which a mobile phase can permeate and use of the same. |
| IP Reference | US2018094022 |
| Protection | Patent granted |
| Year Protection Granted | 2018 |
| Licensed | Yes |
| Impact | The patent is now owned by the spin-out company Puridify and forms part of company's patent portfolio. The company was bought by GE Healthcare in November 2017. http://www.pressreleasepoint.com/ge-healthcare-acquires-bioprocessing-start-puridify |
| Title | Chromatography medium |
| Description | The present invention provides a process for preparing a functionalised polymeric chromatography medium, which process comprises (I) providing two or more non- woven sheets stacked one on top of the other, each said sheet comprising one or more polymer nanofibres, (II) simultaneously heating and pressing the stack of sheets to fuse points of contact between the nanofibres of adjacent sheets, and (III) contacting the pressed and heated product with a reagent which functionalises the product of step (II) as a chromatography medium. |
| IP Reference | CN105636686 |
| Protection | Patent application published |
| Year Protection Granted | 2016 |
| Licensed | Yes |
| Impact | The patent is now owned by the spin-out company Puridify and forms part of company's patent portfolio. The company was bought by GE Healthcare in November 2017. http://www.pressreleasepoint.com/ge-healthcare-acquires-bioprocessing-start-puridify |
| Company Name | Puridify |
| Description | Puridify's technology, FibroSelect - a novel chromatography reagent, offers significant advantages across key performance attributes that not only allow chromatography associated costs to be reduced by up to 90% but are also well aligned to meet the industry demands today and as the market evolves. |
| Year Established | 2013 |
| Impact | Puridify have proven at research scale (0.2mL reagent) that their technology can operate at 50x throughput due to better permeability and fast mass transfer. This improves process economics by increasing productivity and is also beneficial when processing labile products. The reagent has shown better resistance than our competitors to impurity fouling and cleaning steps, a common cause of performance degradation over multiple cycles. The technology allows cheap and rapid bioprocess development due to uniform performance at all scales, promoting its adoption in industry. |
| Website | http://puridify.com/ |