NEXT-GENERATION AUTOMATION AND PAT IMPLEMENTATION FOR QBD AND ENHANCED APPROACHES IN CELL AND GENE THERAPY MANUFACTURING

Innovate UK (iUK), the United Kingdom (UK)’s national innovation agency, and Innosuisse, the Swiss counterpart, are co-founding a project to enhance innovation in cell and gene therapy (CGT) manufacturing.

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

The project offers a remarkable chance to introduce revolutionary bioprocess automation and digitalization solutions to the CGT field to support cutting-edge research efforts and accelerate the development of life-saving therapeutics, ultimately expediting their entry into the market.

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 ATEEM spectrometer, the ChemoMetec XcytoMatic® XM30™ cell counter, and the Endress+Hauser Rxn2 Raman spectrometer.

The first two PATs mentioned are limited to at-line usage, necessitating substantial manual intervention for operation. However, through seamless 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 control.

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.

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.