CDMO WuXi Advanced Therapies has announced the expansion of its service capabilities to offer a fully integrated closed process platform
CDMO WuXi Advanced Therapies has announced the expansion of its service capabilities to offer a fully integrated Closed Process CAR-T Cell Therapy Platform. This new platform will accelerate the timeline for cell and gene therapy development, manufacturing and release while providing greater predictability.
Felix Hsu, Senior VP and Global Head of WuXi AppTec Advanced Therapies, said: "We are hopeful that this new platform will not only enable groundbreaking advances in the field of cell and gene therapies, but also allow our customers to deliver innovative treatments to patients with even greater predictability and speed, saving lives in the process."
This platform will provide advanced therapy companies worldwide with integrated capabilities for CAR-T production, including: in-stock raw materials with established batch records; regulatory and technical expertise; process and analytical development; full in-process and release testing; robust quality control and quality assurance oversight; and access to facilities that offer the capacity and flexibility to meet companies' timeline needs.
This platform provides one of two modalities depending on dose requirements, using a list of pre-evaluated equipment, technologies and materials with developed closed processes for different unit operations - an innovation that will increase the speed in getting new cell and gene therapies to market.
CAR-T therapies are a highly-specialised form of immunotherapy used as a personalised treatment option for certain eligible patients suffering from forms of aggressive cancer, such as adults with advanced lymphomas, children with relapsed or refractory acute lymphoblastic leukaemia and other forms of blood cancer.
Continued investments in the integration of CAR-T therapy platforms during the drug development process is a critical step toward understanding the possible applications of these therapies and the ways in which more patients may benefit.