The platform will be released through WuXi AppTec’s subsidiary, WuXi Advanced Therapies, which is a contract development and manufacturing organization (CDMO) for cell and gene therapies. While the platform itself aims to accelerate the timelines for the development of chimeric antigen receptor (CAR)-T therapies.
The ‘closed process’ system will contain everything necessary to take a clinical candidate through development with the CDMO having integrated capabilities for CAR-T production.
WuXi stated that this includes in-stock raw materials; full in-process and release testing; regulatory and technical expertise; process and analytical development; quality control and quality assurance oversight; as well as access to the CDMO’s facilities.
The organization suggested that the platform will ‘increase the speed’ to bring new cell and gene therapies to market.
As part of the platform, there are two modalities that depend on dose requirement, with each using a list of pre-evaluated equipment, technologies and materials for the closed processes.
Last month, WuXi Advanced Therapies launched a fully integrated adeno-associated virus (AAV) vector suspension platform, which aims to provide the same specialized service as the CAR-T platform.
Both AAV-reliant cell and gene therapies and CAR-T therapies form an integral part of the growing pipeline of such therapies.