MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand.
MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services.
“The demand for the biomanufacturing capacity that we are seeing is worldwide,” director of marketing Bethanne Deuel told BioProcess Insider.
Image: Wikimedia Commons/Uwe Dedering
“Many of our clients are looking to do global filings as well. Since we offer both single filings for the NMPA (CFDA), The US FDA, EMEA as well as many others. We have seen an increased interest in Global filings where we will do NMPA and the FDA at the same time. Often times our clients will also include Australia.”
The manufacturing site is the latest biologics offering in mainland China, as the country opens up to third-party biomanufacturing. In 2015, the Chinese government authorized its State Council to carry out its marketing authorization holder (MAH) program, essentially opening up opportunities for local and international CDMOs in the region.
“The biologics manufacturing capacity in China continues to grow,” said Deuel. “While there are facilities not all of them have the capabilities nor the reputation of Mabplex.”
Facilities in China and US
The ‘M2’ facility itself is made up of six independent cell culture suites, each with the ability to support two single-use bioreactors at volumes of up to 2,000 L. Total bioreactor capacity is therefore 24,000 L, and according to Deuel most will be supplied by Sartorius, though there will also be Hyclone and GE single-use bioreactors installed.
“We expect that approximately half of our new facility at the least will be used by existing customers,” Deuel added.
The expansion comes months after MabPlex announced plans to establish a Process Development Center of Excellence in La Jolla, California.
“We are excited to have assembled a world class team with firsthand experience of successfully developing biologics and ADCs from research to commercialization,” MabPlex CEO Jianmin Fang said in May this year.
“Their capabilities will be an asset to our clients as they develop and advance world class therapeutics for patients globally.”