MabPlex International, a fully integrated Contract Development and Manufacturing Organization (CDMO) with sites in China and the United States, has inaugurated their new manufacturing facility in Yantai, Shandong, China.
The grand opening and ribbon-cutting ceremony for their new facility took place on September 6, 2018.
The company, one of the few providers of large-scale ADC production worldwide, was founded in 2013 and specializes in providing complete biologics development and manufacturing solutions. The unique technical expertise helps the company to provide effective solutions for the development and manufacturing of monoclonal antibody and antibody-drug conjugate (ADC) therapeutics, from cell line development and process characterization, to conjugation optimization and cGMP manufacturing.
MabPlex was the first company to manufacture an antibody-drug conjugate in clinical trials in China.
The new manufacturing facility in Yantai, Shandong (China), along with the process development sites in San Diego, CA (USA) and Shanghai (China), will strengthen the company’s ability to meet the needs of new and current clients as they progress to the commercialization phase of their products…
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 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,” noted 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.