WuXi AppTec Selected by IQVIA Stem Cell Center to Serve as GMP Manufacturer of Advanced Therapies
WuXi AppTec (WuXi), a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform company, announced that its Advanced Therapy Unit based in Philadelphia has been selected as a manufacturing partner for advanced therapies through the California Institute for Regenerative Medicine (CIRM) funded IQVIA (formerly QuintilesIMS) Stem Cell Center. In collaboration with its partners, the Stem Cell Center aims to accelerate the preclinical/clinical development, and commercialization of stem cell, cellular and gene-modified therapies via end-to-end solutions and targeted services to advance assets from candidate identification through market authorization and improve the probability of clinical and commercial success.
WuXi AppTec Advanced Therapy Unit offers extensive manufacturing and analytical testing capabilities for a range of advanced therapies including autologous and allogeneic cell therapies, immuno-oncology products such as CAR-T cell therapies, gene therapies and gene-mediated cellular therapies. Operating three Good Manufacturing Practices (GMP) compliant sites with more than 250,000 square feet in the Philadelphia Navy Yard, the site provides state-of-the-art clinical manufacturing and integrated analytical testing with the opportunity to support large scale commercial manufacturing. Through this partnership, Stem Cell Center clients will have access to highly-specialized manufacturing resources at a time where the industry is experiencing significant capacity constraint to support the growing number of innovative therapies.
“We are very proud to be selected as GMP manufacturing CMO partner by the IQVIA Stem Cell Center,” said Felix Hsu, Senior Vice President of WuXi AppTec’s Advanced Therapy Unit. “We believe that the investment we have made in building these sophisticated manufacturing resources and highly-trained staff will provide a valuable benefit for the promising cell and genetic therapies emerging from CIRM-funded innovators.”
“Advanced therapies like CAR T-cells and gene therapy vectors offer significant new therapeutic options for cancer patients and those suffering from crippling genetic diseases. We are pleased to be at the forefront of this field, providing our partners with cutting-edge cGMP manufacturing capabilities and capacities,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec.