Chime Biologics Achieved a Milestone Leap by Completion of Process Performance Verification with High Quality and Efficiency
On December 10, 2020, all the CMC (Chemistry, Manufacturing and Control) data required for the New Drug Application (NDA) has been submitted to a client by Chime Biologics, which means that Chime Biologics has successfully completed the whole CMC process performance evaluation from cell line development to commercial production, achieving a milestone leap.
The project took less than 2 years from technology transfer at the beginning to 2000L GMP production for clinical research, followed by process characterization, process validation and other NDA application related work at the late stage of product development. Three batches of PPQ (Process Performance Qualification) Drug Substance / Drug Product were successfully completed in about 2.5 months. Chime Biologics adopted the international concept of quality by design (QbD) and systematically used the quality risk management method to complete the project with high quality and efficiency, which has also won high praise from our client. This project is scheduled to apply for NDA with Chime Biologics as the manufacturer early next year. This will be the first commercial production of Chime Biologics which is scheduled to undertake at least two commercial production projects within three years.
Peter Peng, General Manager of Chime Biologics, said, “In the first half of 2020, we have overcome all difficulties to ensure the normal operation of all projects during the COVID-19 pandemic. The successful completion of this work relies on the strong exploring research spirit, selfless dedication and cooperation from colleagues from all departments of the company. We will try our utmost to enable and sincerely wish our clients to complete the application and launch the products to market as soon as possible! At the same time, in order to meet the commercial production needs from more and more clients, Chime Biologics has also started the second phase of plant expansion, which is scheduled to invest 900 million US dollars in five years to build a CDMO hub integrating biopharma research, development and commercial production with a total of over 100,000 liters of cell culture capacity.”
As a CDMO partner in the development and production of biological products, Chime Biologics has a professional team with both local experience and international vision, full of enthusiasm and vigor. We will continue to innovate, grow and work together to contribute to the development of biopharma industry in China!