Closed point-of-care Preparation (CPrep)
Lead Research Organisation:
University College London
Department Name: Biochemical Engineering
Abstract
This project will establish a world-class consortium to innovatively address a generic bioprocessing market failure for the
cell therapy industry (CTI) - a robust validated platform technology to enable post-manufacturing process steps to be
carried out at the point of care (PoC). This Closed-point-of-care-Preparation device (CPrep) will increase patient safety and
enable a new generation of cell therapies that would otherwise have to be shipped fresh with its inherent logistics
problems.
cell therapy industry (CTI) - a robust validated platform technology to enable post-manufacturing process steps to be
carried out at the point of care (PoC). This Closed-point-of-care-Preparation device (CPrep) will increase patient safety and
enable a new generation of cell therapies that would otherwise have to be shipped fresh with its inherent logistics
problems.
Planned Impact
Economic impact: Significant returns to the UK-based commercial partners over a 5-20 year timeframe. CPrep would
enable CTI to develop a new generation of products deploying a robust 510K/CE approved PoC closed final processing
system. UK CTI companies would have first access to CPrep as it will be developed through strategic UK partnering.
CPrep would enable UK CTI to supply the whole UK plus rest of the world. Social impact: CPrep would enable therapies to
gain EMA/FDA market approval faster (less loss of trial material), safer therapies (eliminating operator error in PoC
preparation), plus increased clinical indications - a win for patients and their carers. Environment: Fresh product with short
shelf life (hours/few days) inevitably leads to waste product. CPrep would thus lead to a reduction in overall resource
requirements.
enable CTI to develop a new generation of products deploying a robust 510K/CE approved PoC closed final processing
system. UK CTI companies would have first access to CPrep as it will be developed through strategic UK partnering.
CPrep would enable UK CTI to supply the whole UK plus rest of the world. Social impact: CPrep would enable therapies to
gain EMA/FDA market approval faster (less loss of trial material), safer therapies (eliminating operator error in PoC
preparation), plus increased clinical indications - a win for patients and their carers. Environment: Fresh product with short
shelf life (hours/few days) inevitably leads to waste product. CPrep would thus lead to a reduction in overall resource
requirements.
Organisations
Publications
Tostoes R
(2017)
A novel filtration system for point of care washing of cellular therapy products.
in Journal of tissue engineering and regenerative medicine
| Title | APPARATUS AND METHOD FOR FILTRATION OF A SUSPENSION |
| Description | The present invention provides devices suitable for filtration including diafiltration of a suspension containing a species such as particles, cells or macromolecules, apparatus comprising such devices and methods of using the devices and apparatus. The devices of the invention comprise a vessel having a filter that divides the vessel into a first chamber and a second chamber provided with various outlet ports. Gas is used to finally concetrate the suspension (118) in the filtration chamber by displacing the liquid up to 95% through the filter (14). |
| IP Reference | WO2015063489 |
| Protection | Patent application published |
| Year Protection Granted | 2015 |
| Licensed | Yes |
| Impact | Other patents applied for. New company founded to develop and commercialise the technology - Closed Cell Systems http://www.closedcellsystems.com/ Additional funding received to further develop the technology from Innovate UK £1.1M - "CPrep - Closed point of care preparation device (phase 2)" |
| Title | Volume Reduction Filtration Devices For Cell Suspension And Method |
| Description | The present invention provides devices, apparatus and systems suitable for achieving volume reduction in a liquid containing a species in suspension and methods of use thereof. The apparatus of the invention comprises (i) a filter device comprising: a tubular first chamber having a filter provided in a surface thereof, a second chamber in fluid communication with the first chamber through the filter, the device being provided with an inlet port opening to the first end of the first chamber, an outlet port opening to the second end of the first chamber, and a filtrate port opening to the second chamber, and (ii) a fluidic pathway from the outlet port, wherein the apparatus is configured to introduce the first liquid and a second fluid immiscible with the first to the first chamber and the apparatus comprises a flow cut-off means in the fluidic pathway from the outlet port. |
| IP Reference | US2016243502 |
| Protection | Patent application published |
| Year Protection Granted | 2016 |
| Licensed | No |
| Impact | The involvement in this project was worthwhile. As a result of this project, UCL has filled 2 international patents, disseminated its work in 3 international conferences and has a manuscript ready to be submitted for peer review. Most importantly, the 2 patents have been licensed to the new company which came out of the consortium, Closed Cell Systems, thus demonstrating UCL's engagement with the biotech sector's SMEs. Thus, UCLs ambitious goals for this project were clearly met. |
| Company Name | Closed Cell Systems |
| Description | Closed cell systems is a solution provider. We re-engineer cell therapy manufacturing processes and also supply bespoke, closed, automated equipment and disposables. Typically we work with you to map your end to end manufacturing process, ensuring an optimal match with your business strategy and identifying and prioritising improvements. In areas requiring new or changed equipment, we can quickly design and supply prototypes ready for evaluation and testing. Once the prototypes deliver the benefits required, we production engineer them to ensure they are GMP compliant and cost effective. Finally we manage the supply chain to ensure a robust supply of validated process equipment and disposables. |
| Year Established | 2014 |
| Impact | See above |
| Website | http://www.closedcellsystems.com/ |