Lonza has signed an agreement with GE Healthcare under which GE Healthcare will deliver a biologics facility to Lonza in Guangzhou, China.
As the facility is part of a larger biomanufacturing initiative between GE Healthcare and Guangzhou Development District, the agreement will be finalized when contracts have been signed with the development district. Later today, Lonza will sign a memorandum of understanding with the district to take the project forward. The new facility will give Lonza Pharma & Biotech a strategic base in China to respond to growing demand for high-quality CDMO services in the country.
By working with GE Healthcare to develop the new facility, based on the KUBio platform, an off-the-shelf biologics factory, Lonza intends to offer its suite of antibody development services and manufacture GMP-certified batches by 2020. The two companies will work closely on the design of the 183,000-square-foot site, which will include 70,000 square feet of lab space and one KUBio facility.
The labs will house Lonza’s proprietary platforms for cell-line construction, including the GS Gene Expression System, as well as process development, cell banking, and pilot labs. The KUBio unit will enable small-scale GMP manufacturing equipped with GE Healthcare’s single-use biomanufacturing technologies, including 1,000L and 2,000L bioreactors, combined with Lonza’s automation platforms for clinical and early-commercial supply.
GE Healthcare is working with the Guangzhou Development District to support large-scale manufacturing of biopharmaceuticals in China.
The facility in China will extend Lonza Pharma & Biotech’s global biologics network that provides development and manufacturing services from gene through IND and BLA to mature commercial supply. In addition to the new Chinese site, the network comprises small-, mid- and large-scale assets in Switzerland, the United States, the U.K., Spain, and Singapore.
Lonza plans to hire and train more than 160 staff, and the new site will benefit from the company’s global standards of technological and operational experience. With more than 20 successful FDA approvals for biologics, combined with international regulatory expertise, Lonza now will be able to offer the same standards in China as it does elsewhere.
China has been historically underserved by biologics, but demand for antibody therapies is expected to grow significantly over the coming years. A strong scientific base and commercial instruments put into place by the Chinese authorities are encouraging domestic companies that are developing innovative therapies for the global market, as well as multinationals with manufacturing requirements in the country.
In particular, national rollout of the Marketing Authorization Holder scheme by 2019 paves the way for dedicated CDMO services in China, according to Lonza.
(Source: Lonza Group)