Cellularforce, a leading one-stop service provider for Contract Development and Manufacturing Organization or CDMO outsourcing manufacturing of antibody drugs in China, is on the move.
Located in the Taizhou Medical High-tech Zone, Taizhou city, Jiangsu province, Cellularforce is a subsidiary of Qyuns Therapeutics.
It plans to deeply explore and break through key technologies such as dual antibody drugs and antibody drug compound preparations, as well as boost international cooperation.
In October last year, the first domestic biosimilar drug of ustekinumab injection, jointly developed by Qyuns Therapeutics and Huadong Medicine, was approved for commercial sales.
An impressive view of the premises of Cellularforce. [Photo/WeChat account: weigg6666]
The drug is a recognition of the CDMO service capabilities of Cellularforce. That's because it's the first industrialized product to successfully complete the full cycle, from molecular design and evaluation, process development, clinical sample production, analysis and quality management, registration and application to commercial production, since the opening of Cellularforce's biological antibody drug industrialization base.
Wu Yiliang, general manager of Cellularforce, praised local government policies and services.
Wu noted that when the company obtained the drug registration certificate for the ustekinumab injection on Nov 5 last year, there remained the requirement for a "Notice of Drug GMP Compliance Inspection Results" before production began, while the seller hoped to ship products within a week.
But the Taizhou zone immediately coordinated with provincial bureaus to prioritize inspection resources, enabling it to quickly obtain the notification letter and complete the first shipment of the products four days later, Wu added.