IMRC for Bioprocessing
Lead Research Organisation:
University College London
Department Name: Biochemical Engineering
Abstract
It is now widely accepted that up to ten years are needed to take a drug from discovery to availability for general healthcare treatment. This means that only a limited time is available where a company is able to recover its very high investment costs in making a drug available via exclusivity in the market and via patents. The next generation drugs will be even more complex and difficult to manufacture. If these are going to be available at affordable costs via commercially viable processes then the speed of drug development has to be increased while ensuring robustness and safety in manufacture. The research in this proposal addresses the challenging transition from bench to large scale where the considerable changes in the way materials are handled can severely affect the properties and ways of manufacture of the drug. The research will combine novel approaches to scale down with automated robotic methods to acquire data at a very early stage of new drug development. Such data will be relatable to production at scale, a major deliverable of this programme. Computer-based bioprocess modelling methods will bring together this data with process design methods to explore rapidly the best options for the manufacture of a new biopharmaceutical. By this means those involved in new drug development will, even at the early discovery stage, be able to define the scale up challenges. The relatively small amounts of precious discovery material needed for such studies means they must be of low cost and that automation of the studies means they will be applicable rapidly to a wide range of drug candidates. Hence even though a substantial number of these candidates may ultimately fail clinical trials it will still be feasible to explore process scale up challenges as safety and efficency studies are proceeding. For those drugs which prove to be effective healthcare treatments it will be possible then to go much faster to full scale operation and hence recoup the high investment costs.As society moves towards posing even greater demands for effective long-term healthcare, such as personalised medicines, these radical solutions are needed to make it possible to provide the new treatments which are going to be increasingly demanding to manufature.
Organisations
- University College London (Lead Research Organisation)
- MSD (United States) (Project Partner)
- National Institute for Biological Standards and Control (Project Partner)
- Novo Nordisk (Denmark) (Project Partner)
- Liminal BioSciences (United Kingdom) (Project Partner)
- General Electric (United Kingdom) (Project Partner)
- BioPharm (United Kingdom) (Project Partner)
- BIA Seperations (Project Partner)
- Eli Lilly (United Kingdom) (Project Partner)
- Amgen (United Kingdom) (Project Partner)
- Protherics UK Limted (Project Partner)
- Bio Products Laboratory (United Kingdom) (Project Partner)
- BTG International (United Kingdom) (Project Partner)
- St George's, University of London (Project Partner)
- Intercell Biomedical Ltd (Project Partner)
- UCB Pharma (United Kingdom) (Project Partner)
- GlaxoSmithKIine (Project Partner)
- AstraZeneca (United Kingdom) (Project Partner)
- Public Health England (Project Partner)
- Pfizer (United Kingdom) (Project Partner)
- Pall Corporation (United Kingdom) (Project Partner)
- Lonza (United Kingdom) (Project Partner)
- General Electric (Sweden) (Project Partner)
- Avecia (United Kingdom) (Project Partner)
- Novasep SAS (Project Partner)
- Eli Lilly (United States) (Project Partner)
- Pfizer (United States) (Project Partner)
- Wyeth USA (Project Partner)
- Sartorius (United Kingdom) (Project Partner)
- GlaxoSmithKline R&D Ltd (Project Partner)
Publications
Close E
(2014)
Modelling of industrial biopharmaceutical multicomponent chromatography
in Chemical Engineering Research and Design
Close EJ
(2013)
Fouling of an anion exchange chromatography operation in a monoclonal antibody process: Visualization and kinetic studies.
in Biotechnology and bioengineering
Daniel Bracewell (Co-Author)
(2012)
Chromatography modelling at bead level for bioprocess design and understanding
Eames I
(2012)
Study of a novel tube forming method for preparing engineered blood vessels
in Chemical Engineering Science
Edwards-Parton S
(2008)
Principal component score modeling for the rapid description of chromatographic separations.
in Biotechnology progress
Gerontas S
(2010)
Integration of scale-down experimentation and general rate modelling to predict manufacturing scale chromatographic separations.
in Journal of chromatography. A
Gerontas S
(2013)
Chromatography modelling to describe protein adsorption at bead level.
in Journal of chromatography. A
Hardick O
(2011)
Nanofibre fabrication in a temperature and humidity controlled environment for improved fibre consistency
in Journal of Materials Science
Hardick O
(2013)
Nanofiber adsorbents for high productivity downstream processing.
in Biotechnology and bioengineering
Hutchinson N
(2009)
Ultra scale-down approach to correct dispersive and retentive effects in small-scale columns when predicting larger scale elution profiles.
in Biotechnology progress
Description | The methods enable more rapid progression from a life science discovery to a real viable process for manufucature. |
Exploitation Route | Spin outs are in place and more planned via a HEFCE funded Technology transfer programme |
Sectors | Healthcare Manufacturing including Industrial Biotechology |
Description | The IMRC research is now embedded in UCL teaching programmes and is central to skills development in graduates going on to a wide range of careers. Hence a bipharma led initiative is starting to have impact in areas such as food bioprocessing and industrial biotechnology. |
First Year Of Impact | 2019 |
Sector | Agriculture, Food and Drink,Healthcare,Manufacturing, including Industrial Biotechology |
Impact Types | Economic |
Description | BSI Commitee member |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline committee |
Description | EPSRC SAN |
Geographic Reach | National |
Policy Influence Type | Participation in a guidance/advisory committee |
Impact | The EPSRC SAN is instrumental in helping the Council to formulate its research funding priorities |
Description | Membership of a guideline committee - Elected Management Board Member of BBSRC BioProNet (2015) |
Geographic Reach | National |
Policy Influence Type | Membership of a guideline committee |
Impact | BioProNet is key to advising and shaping the funding opportunities between BBSRC and EPSRC |
Title | Ultra scale-down (USD) technologies |
Description | CE marked devices (10s mL scale) to mimic the process engineering environment to which biological materials are exposed during large scale manufacture , especially of therapeutics. For example a USD shear device, a USD membrane device Andrea CME Rayat, Alex Chatel, Mike Hoare, Gary J Lye, Ultra scale-down approaches to enhance the creation of bioprocesses at scale: impacts of process shear stress and early recovery stages, Current Opinion in Chemical Engineering, Volume 14, November 2016, Pages 150-157, ISSN 2211-3398, http://dx.doi.org/10.1016/j.coche.2016.09.012 |
Type Of Material | Improvements to research infrastructure |
Year Produced | 2016 |
Provided To Others? | Yes |
Impact | Prediction for processing mammalian cell broths in industrial continuous flow centrifuges Maximising recovery of novel vaccines. CE marked devices provided largely to researchers in bioprocessing industry via research collaborations |
Company Name | Puridify |
Description | Puridify develops purification solutions for biotherapeutic manufacturing. |
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://www.puridify.com |