MabPlex International, Ltd., a fully integrated Contract Development and Manufacturing Organization (CDMO) with sites in China and the United States, providing comprehensive (cell line) development, process characterization, conjugation optimization, cGMP manufacturing, and aseptic fill finish solutions for monoclonal antibody (mAb) and antibody-drug conjugate (ADC) therapeutics, announced the grand opening and ribbon-cutting ceremony for their new M2 manufacturing facility in Yantai, China. The opening ceremony took place on September 6, 2018.
This milestone will enhance MabPlex’s ability to deliver Phase III and commercial development and manufacturing solutions to clients in multiple global markets and expand the company’s manufacturing operations to a total of approximately 750,000 ft²; with 400,000 ft² devoted specifically to cGMP execution.
The completed ‘M2’ facility includes six independent cell culture suites, four independent purification suites, and a cGMP warehouse. Each of the six cell culture suites will support up to two single-use bioreactors at volumes of up to 2,000L (with a maximum capacity of 24,000L).
“With a growing number of novel and increasingly complex drug constructs in early development pipelines and new targeted therapies, such as ADCs, in late stage development and moving to commercialization, there is a growing global demand for specialized CDMOs,” said Jianmin Fang, Ph.D, Chairman and CEO of MabPlex International, Ltd.
The new facility was built in response to the growing, global, demand for biomanufacturing capacity and complies with all international manufacturing regulations.
“This new facility, along with the opening of our San Diego and Shanghai process development sites, will increase our capacity to meet the needs of our new and current clients as they progress to commercialization,” Fang added.
Earlier this year, MabPlex USA, a subsidiary of MabPlex International, Ltd., opened the company’s new state of the art Process Development Center of Excellence located in La Jolla, CA (USA) near San Diego, CA (USA) with scale up capacity to 200L, offering world class expertise supporting cell line development, upstream and downstream process development, Antibody-drug Conjugate (ADC) development, analytical development and formulation development.