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Keji Pharmaceutical's US CGMP production plant completed the first clinical batch production of CAR-T products

 Last Update: 2022-09-06
 Source: Internet
 Author: User

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SHANGHAI, Sept.

Exterior view of Keji Pharmaceutical's CGMP production plant

The RTP GMP production facility, with a total construction area of approximately 3,300 square meters, will provide Keji Pharmaceuticals with additional capacity to produce autologous CAR-T cell products for 700 patients per year to support clinical research and early commercial use in North America and Europe

"The completion of the first CAR-T product for patients in the US RTP GMP manufacturing plant is a major milestone for Keji

The internal environment of Keji Pharmaceutical's CGMP production plant

In addition to several ongoing clinical studies in China, Keji Pharmaceutical has two ongoing IND trials approved by the US FDA and Health Canada, including CT053 for the treatment of relapsed/refractory multiple myeloma Pivotal Phase 2 clinical trial and Phase 1b clinical trial of CT041 in advanced gastric and pancreatic cancer

Source: Keji Pharmaceutical Holdings Co.

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