A UK and Swiss consortium has been awarded over £750,000 from the national innovation agencies Innovate UK and Innosuisse to integrate new digitisation and process analytical technologies (PATs) into the manufacturing of cell and gene therapies. The project aims to make advanced therapies more affordable to healthcare systems by reducing the cost of manufacturing these therapies.
The consortium comprises the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry; Securecell, a high-tech solution provider for the life science industry; and DataHow AG, a technology company specialised in data analytics and bioprocess modeling.
In the project, Securecell will integrate PATs into their bioprocess sampling system and software. The system will be implemented into the CGT Catapult’s PAT laboratory and demonstrated during the production of an adeno-associated virus (AAV). In collaboration with DataHow, the data produced will be used to explore the benefits of using hybrid modelling approaches, such as digital twins, during the manufacturing of advanced therapies.
Matthew Durdy, Chief Executive of the CGT Catapult, said: “We look forward to collaborating closely with biotech experts Securecell and analytics and modelling experts DataHow to develop innovative, automated approaches that could potentially lower the manufacturing costs of cell and gene therapies.
“This project is an excellent example of how the advanced therapies sector can use new technologies to make highly complex and regulated processes more efficient and cost-effective, which is vital when it comes to ensuring that these therapies are affordable and accessible to healthcare services across the globe.”
Carlo Andretta, Chief Executive Officer at Securecell, said: “We are looking forward to collaborate with industry experts in cell and gene therapy, cutting-edge analytical device manufacturing, and hybrid modelling.
“The unique expertise of each collaborator will be combined to develop innovative solutions for automated on-line analysis within the ATMP manufacturing space. This project will set new standards when it comes to workflow automation, process digitalisation and advanced data analytics in ATMP manufacturing and benefit the patients of tomorrow.”
Moritz von Stosch, Chief Innovation Officer at DataHow, said: “The collaboration between the CGT Catapult, Securecell, and DataHow brings together a powerful combination of expertise in CGT processes, data management, and model-based process development, which offers a unique opportunity to reimagine the development and operation of CGT processes.
“By showcasing how digital technologies can mitigate risks in CGT process development and enhance outcomes without requiring additional resources, we can create a pivotal ‘aha moment.’ This moment could mark a shift where digital transformation evolves from a theoretical concept to a practical reality.”
