Chime Biologics Launched PAI Manufacturing Officially to Start the GMP Commercial Manufacturing
The project was introduced successfully on January 10, 2019, which means the capability of Chime Biologics has been greatly recognized. And later on December 10, 2020, the process performance qualification (PPQ) of the project was completed, to prove that Chime successfully finished the whole process of CMC from cell line development to commercial manufacturing, which is a milestone in Chime Biologics’ history. On November 25, 2021, the manufacturing of this project officially started. In the future, more projects are looking forward to starting.
Dr. Zeng Xianfang, CEO of Chime Biologics, said, “This is the first commercial product of Chime Biologics, meaning a very good start for us. We will work together with our customers to facilitate the commercialization of this project, delivering our commitment to them. In early November 2021, we set up Chime Biologics Innovation Center in Shanghai Zhangjiang Science City. Meanwhile, the GMP-2 expansion project is under construction, which will drive the rapid growth of our CDMO business and meet the demands of customers for more commercial capacity. In the future, we will put phase 2 of the large-scale commercialization site into use, starting a new era of biopharmaceutical innovation for Chime Biologics.”
About Chime Biologics
Chime Biologics is a leading CDMO with the world’s first modular biopharmaceutical factory, KUBio. It empowers the entire biologics processes – from cell line development to commercial manufacturing. Chime Biologics provides one-stop CMC solutions to worldwide biomedical customers, relying on cell line development and advanced technology development from its Shanghai Innovation Center and proven success in IND-enabling through BLA filing at its Wuhan campus. We share a common goal to make cutting-edge biologics affordable and accessible to all patients globally, fulfilling its commitment to human health.