Development and optimisation of downstream processing for next generation biotherapeutics

Lead Research Organisation: University College London
Department Name: Biochemical Engineering

Abstract

In recent years there has been rapid development of a "Next Generation" of protein-based therapeutics, yet the need remains for new manufacturing processes that can deliver these at a price healthcare providers can afford. For the first time these new therapies can safely modify a patient's DNA, or harness the body's own immune system, to treat inherited diseases, neurological conditions, and cancer. However, to achieve this clinical functionality the complexity and size of the therapeutic protein has increased. This has meant that existing purification technologies have been unable to be applied effectively in this new application. This project aims to build on existing collaborations and feasibility data to develop new purification tools and strategies that can be applied across a range of next generation biotherapeutics to enable their cost effective manufacture delivering novel therapies to patients at an aceeptable price for healthcare payers.

Publications

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Ruscic J (2019) Lentiviral Vector Purification Using Nanofiber Ion-Exchange Chromatography. in Molecular therapy. Methods & clinical development

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Turnbull J (2019) Adenovirus 5 recovery using nanofiber ion-exchange adsorbents. in Biotechnology and bioengineering

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Turnbull J (2019) Cover Image, Volume 116, Number 7, July 2019 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 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. A particularly focus is the application of the technology to viral vector manufacture for use in gene therapy and T-cell therapy. 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.
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.uclb.com/2017/11/30/ucl-spinout-company-puridify-limited-has-been-acquired-by-ge-healthcare/
 
Description This exploitation is supported by the original patent application (PCT/GB2012/052768) and a new patent application filed during this project (PCT/GB2013/052626). An on-going IP strategy to build and further protect future commercialisation opportunities is structured and continually evolving based on the development work that is being carried out. The spin-out Puridify was acquired by GE Healthcare in November 2016. https://www.uclb.com/2017/11/30/ucl-spinout-company-puridify-limited-has-been-acquired-by-ge-healthcare/
First Year Of Impact 2016
Sector Healthcare,Manufacturing, including Industrial Biotechology,Pharmaceuticals and Medical Biotechnology
Impact Types Societal,Economic

 
Description Centre of Excellence
Amount £1,393,742 (GBP)
Organisation PALL Europe 
Sector Private
Country United Kingdom
Start 01/2018 
End 12/2024
 
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
 
Description Ultra Low-cost Transferable Automated (ULTRA) Platform for Vaccine Manufacturing
Amount $17,670,648 (USD)
Funding ID OPP1154682 
Organisation Bill and Melinda Gates Foundation 
Sector Charity/Non Profit
Country United States
Start 11/2016 
End 11/2021
 
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
 
Description BioProNet Bioprocess Intensification Symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact BioProNET Bioprocess Intensification Symposium
4th July 2018
The continued growth of the biopharmaceutical industry is being challenged by a greater number and variety of products than in the past. The industry is also increasingly concerned with the affordability of these products. These key factors means process intensification has become a critical objective. The goal is higher productivity processes to enable small process trains, resulting in cost-effective, lean, and agile manufacturing facilities. The symposium assembles 8 leaders from the biopharmaceutical industry and academia who will present their latest findings and opinions on the subject. By bringing together scientists and engineers from academia and industry who are actively engaged in bioprocess intensification the event will provide forum for lively debate.
Year(s) Of Engagement Activity 2018
URL http://biopronetuk.org/biopronet-funded-collaboration-building-workshops/