Pascal Vonlanthen
Next-generation automation and PAT implementation for QbD and enhanced approaches in cell and gene therapy development and manufacturing
Innovate UK (iUK), the United Kingdom (UK)'s national innovation agency, and Innosuisse, the Swiss counterpart, are co-funding 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, 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 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 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 on-line, enabling real-time data delivery for advanced process operation.
All generated bioprocess and analytical data will be transferred from Lucullus® to DataHow's advanced hybrid modeling software, DataHowLab. The 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.
For more details, please read the official press release here:
Pascal Vonlanthen
