Drug Substance Manufacturing
Chime Biologics is the first to embrace modular facilities with single-use bioprocessing technology. Our world’s first modular biomanufacturing facility meets international cGMP standards
We offer flexible biomanufacturing solutions at diverse scales, our facility is featured with various bioreactor sizes ranging from 50L, 200L, 500L to 2000L. The production capacity can be rapidly adjusted according to the customization requirement, catering to your need for projects at different development stages.
We use disposable systems for all our bioreactors and media/buffer preparation tanks. Single-use consumables are utilized to provide the advantages of cost- and time-saving on lengthy in-house cleaning, sterilization and maintenance for all components, reducing the use of cleaning chemicals, allowing efficient changeover time and flexible process, and reducing cross contamination risks.
We can manufacture at 50L and 200L scales in our qualified PD/MSAT laboratory to support process development and supply for non-clinical program materials. In our GE KuBio facility, we offer cGMP production scales at 200L, 500L and 2000L to support clinical program and commercial manufacturing. The facility is designed to meet the requirements of NMPA, EMA, US FDA and PIC/S GMP standard, and its 24/7 continuous operation during production is fully supported by our round-the-clock engineering services to gain real-time visibility, ensure seamless process and assure quality.
We believe open communication and high transparency are key successful factors to all projects. Therefore, we welcome and support your “Personnel in Plant” during manufacturing process to allow project oversight on project development and progress.