A UK consortium of life sciences companies has launched a project to develop automated manufacturing controls for use in the manufacture of biologics.
Consisting of BiologIC Technologies, Biopharm Services, CPI, Pall Corporation, and SCIEX, the consortium’s project is worth a total of £3.1 million and has received support from Innovate UK to platform its technology.
The project is aiming to increase flexibility and sustainability of manufacturing procedures, reducing batch failures and potentially helping advance progress towards the real-time product release of biopharmaceutical drugs. In doing so, there is a potential this could help reduce manufacturing costs and improve product quality, lowering costs to the NHS, and increasing access to life-changing drugs for patients.
The manufacture of monoclonal antibodies (mAb) will be the project’s focus which 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.
For the project, 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 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.”