A U.K.-based consortium consisting of BiologIC Technologies, Biopharm Services, CPI, Pall, and SCIEX launched a project 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, according to Andrew Sinclair, president of Biopharm Services.

This project plans 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, notes the consortium.

Project focuses on the manufacture of an mAb product

The project focuses on the manufacture of a monoclonal antibody (mAb) and is reportedly 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 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 optimizing the continuous bioprocess as measured by cost of goods, facility throughput, scalability, and environmental sustainability.

“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, explained Sinclair. “By clarifying the business case using BioSolve Process and actively sharing practical control strategies, the consortium will advance UK biopharmaceutical manufacturing.”

“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,” added Richard Vellacott, CEO of BiologIC Technologies.”

Harvey Branton, Technology Lead, Biologics, CPI, pointed out that “The automated control of biologics manufacturing needs to transition from proof of concept to implementation in U.K. facilities. This project will incorporate new process analytical tools that can be actively promoted by consortium partners.”

“We provide precision analytics and confident answers to empower our customers to make the right decisions and accelerate biopharma development,” said Mani Krishnan, president of CE and Biopharma at SCIEX. “It is an honor 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.”

According to Ed Hoare, general manager of Pall’s biotech division, “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.”

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