A UK-based consortium consisting of BiologIC Technologies, Biopharm Services, CPI, Pall Corporation, and SCIEX has announced the launch of a project that aims to develop automated manufacturing controls for use in the manufacture of biologics. The project, worth a total of £3.1million, including equipment contributions, has received support from Innovate UK, to platform this advanced technology.
While the accelerated development and scale-up of COVID-19 vaccines has shown what can be achieved by biopharmaceutical manufacturing, it has also highlighted the need to find ways to quickly and reliably develop and manufacture transformative drugs and therapies at scale.
This project aims to address some of the manufacturing challenges faced in the pharmaceutical industry by increasing flexibility and sustainability, reducing batch failures and paving the way towards real-time product release of biopharmaceutical drugs. This will ultimately reduce manufacturing costs and improve product quality, lowering costs to the NHS, and increasing access to life-changing drugs for patients.
The project focuses on the manufacture of a monoclonal antibody (mAb) and is designed with a flexible approach that could be applied to other therapy types, such as vaccines and viral vectors.
The consortium will develop a prototype advanced control strategy that is independent of equipment or control system suppliers and overlay this strategy onto an existing small-scale continuous bioprocessing module operating at CPI.
Through this collaboration, Pall Corporation and SCIEX have contributed equipment and process technology, and experts at CPI will design and implement the automation strategy.
BiologIC Technologies will deploy its full stack industry 4.0 technology platform to develop a smart fluidic system with integrated inline sensing that will enable continuous flow between unit operations. The continuous bioprocessing module will be linked to the BioSolve Process cost modelling platform of lead partner Biopharm Services. BioSolve is used to assess the manufacturability of biopharmaceutical products while optimising the continuous bioprocess as measured by cost of goods, facility throughput, scalability, and environmental sustainability.
Andrew Sinclair, President of Biopharm Services, said, “The automation and control strategy principles developed in this project are not only amenable to traditional biopharmaceuticals but can also be applied to the next generation of virus-based vaccines, mRNA vaccines, gene therapy treatments and targeted biotherapeutics. By clarifying the business case using BioSolve Process and actively sharing practical control strategies, the consortium will advance UK biopharmaceutical manufacturing.”
Richard Vellacott, CEO of BiologIC Technologies said: “As pioneers in next generation bioprocessing, we are delighted to collaborate with world class partners to significantly intensify the continuous manufacturing of therapies and make them more accessible to the patients that need them.”
Harvey Branton, Technology Lead – Biologics, CPI, said: “The automated control of biologics manufacturing needs to transition from proof of concept to implementation in UK facilities; this project will incorporate new process analytical tools that can be actively promoted by consortium partners.”
Mani Krishnan, Vice President of CE & Biopharma at SCIEX, said: “We provide precision analytics and confident answers to empower our customers to make the right decisions and accelerate biopharma development. It is an honour to continue partnering with this consortium. In-line and at-line process analytics reduce waste and increase process robustness. This allows our customers to shorten development timelines and bring affordable high-quality biopharmaceuticals to patients.”
Ed Hoare, General Manager of Pall Corporation’s biotech division, said: “Pall is committed to supporting the development of faster, safer and more economic manufacturing processes and to continue to overcome the challenges of the industrialization of these rapidly growing therapies and vaccines. We are proud to be part of this consortium and to remain at the forefront of the evolution of bioprocessing.”
Notes to Editors
CPI works with partners to translate inventions into products and processes that enhance health and wellbeing, protect and improve our environment and increase productivity across industries.
With a deep understanding of technology fore-sighting, innovation processes and funding, outstanding technical expertise and industry-relevant assets, we enable the accelerated development of transformational products and processes that have the potential to disrupt and revolutionise markets.
We also engage in incremental technological innovation that allows established products and processes to be optimised for better performance and efficient manufacture.
Through the breadth of our technology platforms, we support our partners across many diverse markets, including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.
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About Biopharm Services
Biopharm Services was founded in December 1998 by Andrew Sinclair to develop technology solutions and services for biopharmaceutical product manufacturing. Mr. Sinclair’s life-long passion has been to build a software-based platform that allows the user to change parameters in a biopharmaceutical production process and model the impact on process productivity and economics. This vision led to the development of the first version of our software, BioSolve Process, in 2008. Since its launch, BioSolve Process has been adopted by biopharmaceutical manufacturers, bioprocess suppliers, academia, and engineering firms around the world to improve the efficiency of biopharmaceutical manufacturing.
For more information, visit biopharmservices.com.
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SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. We have been at the forefront of the field of mass spectrometry for 50 years. From the launch of the first ever commercially successful triple quadrupole in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.
Today, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. Our customers are able to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer.
That’s why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.
For more information, visit sciex.com.
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About BiologIC Technologies
BiologIC’s pioneering vision is to be the enabling platform for a radically different generation of highly integrated life science automation. Our breakthrough Industry 4.0 digital hardware allows rapid development and execution of novel, high-value biological workflows in powerful, affordable and application-specific 3D bioprocessing units with dense integrated sensing.
Our first mover advantage and IP in the high-end application of 3D printing creates disruptive value for commercial partners in leading biopharma and technology organisations in the rapidly growing markets of synthetic biology.
For more information, please contact us at firstname.lastname@example.org.