Drug Substance Manufacturing

Chime Biologics has the world’s first modular biopharmaceutical factory which meets international cGMP standards

Our manufacturing lines offer a diverse bioreactor scales at 50L, 200L, 500L and 2000L to support our clients’ needs at different development stages and the production capacity can be adjusted flexibly and rapidly to meet the project requirements. All bioreactors and tanks use single-use disposable bags, which can significantly reduce the cost of cleaning and maintenance and minimize the risk of cross-contamination. Changeover time in the production line can also be effectively optimized according to different projects timelines.

We can manufacture at 50L and 200L scales in our qualified PD/MSAT laboratory to support process development and nonclinical program supplies. In our GE KuBio facility, we offer cGMP manufacturing at 200L, 500L and 2000L scales to support clinical program and commercial manufacturing. The facility is designed to meet the requirement of NMPA, EMPA, US FDA and EU PIC/S GMP.

Our manufacturing operations when in-campaign and engineering support including utilities monitoring is “24/7”.

We permit our clients to locate their personnel as “Personnel in Plant” in the facility where the product is manufactured to provide product oversight during production activities and any development and qualification activities relating to the product. We believe open communication and high transparency are the key factors to the success of every project.