YANTAI, Shandong, China and SAN
DIEGO, Dec. 10, 2018
/PRNewswire-PRWeb/ -- 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.
About MabPlex
MabPlex International, Ltd. was founded in 2013 and specializes in
providing complete biologics development and manufacturing
solutions. Our technical expertise allows us to provide effective
solutions for monoclonal antibody and Antibody-drug Conjugate (ADC)
therapeutics, from cell line development and process
characterization, to conjugation optimization and cGMP
manufacturing. MabPlex is committed to delivering quality solutions
to our customers around the world.
SOURCE Sunvalley Communication, LLC