• Wednesday, May 15, 2024 @ 12:00 am

A UK and Swiss consortium has been awarded over £750,000 from the national innovation agencies Innovate UK and Innosuisse to integrate new digitization and process analytical technologies (PATs) into the manufacturing of cell and gene therapies.

The project consortium includes Cell and Gene Therapy Catapult Limited from the UK, Securecell AG, and DataHow AG from Switzerland. The consortium also benefits from in-kind contributions provided by ChemoMetec A/S and HORIBA UK Limited.

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 its 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 modeling approaches, such as digital twins, during the manufacturing of advanced therapies.

The collaboration aims to systematically integrate a set of advanced Process Analytical Technologies (PATs) into an exemplary AAV gene therapy manufacturing process. These PATs include the Horiba Aqualog 2D fluorescence A-TEEM spectrometer, the ChemoMetec XcytoMatic XM30 cell counter, and the Endress+Hauser Rxn2 Raman spectrometer.

The first two PATs mentioned are currently limited to at-line usage, necessitating substantial manual intervention for operators. Through the planned integration with Securecell's automated sampling platform Numera and process information management system Lucullus, these PATs will be available in-line or on-line, enabling real-time data delivery for advanced process operation.

All generated bioprocess and analytical data will be promptly transferred from Lucullus to DataHow's advanced hybrid modeling software, DataHowLab. This software will enable in silico process development, easing scale-up, and facilitating real-time predictions of future process conditions (see scheme below).

By leveraging these sophisticated technologies and software, the collaboration seeks to enhance process monitoring, control, and optimization in gene therapy manufacturing. The project holds the potential to significantly improve product quality, streamline production efficiency, reduce manufacturing and final product costs, and accelerate the delivery of life-saving gene therapies to patients.

Read the full article here.

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