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)
- National Institute for Biological Standards and Control (Project Partner)
- MSD (United States) (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
Jin J
(2009)
Evaluation of the impact of lipid fouling during the chromatographic purification of virus-like particles from Saccharomyces cerevisiae
in Journal of Chemical Technology & Biotechnology
Lan T
(2012)
Investigating the use of column inserts to achieve better chromatographic bed support.
in Biotechnology progress
Li Q
(2012)
Use of focused acoustics for cell disruption to provide ultra scale-down insights of microbial homogenization and its bioprocess impact--recovery of antibody fragments from rec E. coli.
in Biotechnology and bioengineering
Li Q
(2013)
An ultra scale-down approach to study the interaction of fermentation, homogenization, and centrifugation for antibody fragment recovery from rec E. coli
in Biotechnology and Bioengineering
Ma G
(2010)
Mimic of a large-scale diafiltration process by using ultra scale-down rotating disc filter.
in Biotechnology progress
Matthieu G
(2010)
Protein denaturation and protein:drugs interactions from intrinsic protein fluorescence measurements at the nanolitre scale
in Protein Science
Moore JD
(2011)
Chemical and biological characterisation of a sensor surface for bioprocess monitoring.
in Biosensors & bioelectronics
Ng C
(2014)
Design of high productivity sequential multi-column chromatography for antibody capture
in Food and Bioproducts Processing
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 |