Strong Collaboration Delivers High Quality Contract Manufacturing Capacity in China
"The collaboration has helped MabPlex deliver a flexible, state-of-the-art facility that meets the cGMP standards of the US, EU and China. We look forward to continuing our partnership with Sartorius."
Dr. Fang Jianmin, President, MabPlex
Quick Info
Success Criteria
- Multi-product facility for contract manufacturing
- Highly flexible facility responsive to the capacity needs of MabPlex customers
- Mammalian cell culture production with CHO cell line platform
- cGMP standards of the US, EU and China
- Allows ‘Just In Time’ scheduling of batches for MabPlex customers
Project Duration:
- 18 months
Provided Solutions:
- Biostat® RM 20 & Biostat® RM 50 seed bioreactors
- Biostat® STR 200, Biostat® STR 500, Biostat® STR 1000 & Biostat® STR 2000
- FlexAct Systems for purification
- Filtration, Purification & Fluid Management Technologies
“Sartorius were a key partner in the delivery of MabPlex’s large-scale mammalian cell culture facility for recombinant protein, mAb and ADC production. As one of the China’s largest and fastest expanding CRO/CMO company, we worked closely with their Integrated Solutions team and valued highly their advice and attentiveness. The Biostat® STR bioreactors and other Sartorius single-use technologies have been highly reliable and easily scalable. They have helped MabPlex deliver a flexible, state-of-the-art facility that meets the cGMP standards of the USA, EU and China. We look forward to continuing our partnership with Sartorius. ”
– Dr. Fang Jianmin, President, MabPlex
MabPlex Expands Contract Manufacturing Capacity in China
MabPlex International Ltd wished to establish contract manufacturing and service capacity in Yantai, China. The facility design needed to allow the production of monoclonal antibodies, recombinant proteins and ADCs. The company’s intention was to be a one-stop for biologics production allowing customer to move from gene sequence to cell line development to commercial productions with MabPlex’s CHO cell line platform in the shortest possible time but with a high quality and professional service. The “state-of-the-art” quality systems needed to meet the needs of the USA, EU & Chinese GMP requirements.
Integrated Solutions from Sartorius Stedim Biotech
The Integrated Solutions team from Sartorius Stedim Biotech supported MabPlex in the realization of their facility complex. MabPlex has worked successfully with Sartorius Stedim Biotech’s bioreactors for many years and were very confident of the company’s bioreactor technology and the ease with which it can be scaled-up. Sartorius supported MabPlex from an early stage in the project providing conceptual, basic and detailed engineering designs for the new facility. The collaboration between MabPlex and Sartorius was very successful with the Chinese company being highly appreciative of the responsiveness, engagement and expertise of the Integrated Solutions team. MabPlex valued the speed and quality of the service they received from the Integrated Solutions team and the quality and reliability of the technology Sartorius specified.
100% Cell Culture Success Rate
With the help of Sartorius, MabPlex was able to establish from scratch a GMP biologics production facility in just 18 months. The success rate of cell culture in the new single-use bioreactors is 100% and the contamination rate is 0%. The collaboration with Sartorius has allowed MabPlex to create a ‘state-of-the-art’ facility for monoclonal antibody, recombinant protein production and ADCs. It is extremely flexible and adaptable due to the extensive implementation of single-use technologies that reduce cross contamination risk and shorten production cycles.
Background Information
MabPlex International, Ltd. was established in 2013, and is located in the Yantai, a coastal city in northern China. MabPlex provide CRO/CMO services for global clients producing monoclonal antibodies, recombination proteins and ADCs amongst other products. The company offers key services such a cell line development, large-scale protein expression, purification, formulation, fill/finish, and ADC conjugation. These services are supported by the company’s CHO and ADC platforms. MabPlex is devoted to supplying the most advanced and professional support to help clients shorten R&D cycles and reduce R&D costs through their price-performance ratio and quality service.
Project Manager: Linglan He
