World-class platform will enable biotechnology companies and researchers to accelerate the development, manufacturing and release of cell and gene therapies for patients.
PHILADELPHIA -- WuXi Advanced Therapies, a leading global Contract Development and Manufacturing Organization (CDMO) offering end-to-end contract services for the advanced therapies industry, announced today 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.
"We are excited to launch this world-class Closed Process CAR-T Cell Therapy Platform, which will enhance the integrated support we provide for our customers," said Felix Hsu, Senior Vice President and Global Head of WuXi AppTec Advanced Therapies. "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 world-class 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-specialized form of immunotherapy used as a personalized 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 leukemia 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.
About WuXi AppTec
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec's open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that "every drug can be made and every disease can be treated."
For more information, please visit: http://www.wuxiapptec.com
