UK biomanufacturing team to spearhead development of advanced controls to accelerate drug and vaccine manufacturing

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.”