On November 28, 2019 WuXi ATU Co., Ltd., (WuXi ATU) – a subsidiary of WuXi AppTec, and GeneMedicine – a South Korea-based gene therapy biotechnology company, reported that they have formed a strategic partnership for the development and manufacturing of oncolytic virus products (Press release, WuXi ATU, NOV 28, 2019, View Source [SID1234551775]). Under the terms of the collaboration, WuXi ATU will provide overall process development, manufacturing and Investigational New Drug (IND) filing services for GeneMedicine’s oncolytic virus products.
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This is the first international Chemistry, Manufacturing and Controls (CMC) development and manufacturing project empowered by the Oncolytic Virus contract development and manufacturing organization (CDMO) platform, which has been jointly run by WuXi ATU and GeneSail Biotech (Shanghai) Co., Ltd., (GeneSail) since August 2019. The partnership marks yet another milestone for WuXi ATU to offer the CMC development and manufacturing of oncolytic virus products that meet global standards, enabling global customers to bring advanced therapies to patients far faster.
GeneMedicine has built several pipelines in the clinical stage with a strategic emphasis on solid tumor, pancreatic, metastatic liver and lung cancer. Through the Oncolytic Virus CDMO platform, WuXi ATU will provide overall process development, viral bank manufacturing, viral stock characterization and cGMP commercial manufacturing services to expedite the development and commercialization for key pipelines at GeneMedicine.
Dr. Chae-Ok Yun, Chief Executive Officer of GeneMedicine said, "WuXi ATU has an integrated cell and gene therapy platform covering all types of products with high quality that comply with global standards. This partnership will help us move our pipelines from the clinical stage to commercialization more efficiently."
"We are delighted to work with GeneMedicine in its development of oncolytic virus products," said Dr. Shuyuan Yao, General Manager of WuXi ATU. "We will make full use of our one-stop service platform, which covers the whole process from product development to commercialization, to support our global customers to accelerate the development of gene therapy and bring more advanced treatment to global patients."