China: Bio Manufacturing Lonza Collaborates with GE Healthcare to Construct Biologics Facility
The new facility is expected to set up a strategic base in order to meet the growing demand for high-quality CDMO services in China. Lonza will also aim at manufacturing GMP-certified batches with the aid of GE Healthcare’s off-the-shelf biologics factory, KU Bio.
Guangzhou/China – Lonza has recently announced 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 (GDD), the agreement will be finalised when contracts have been signed with the GDD. Later, Lonza will sign a memorandum of understanding with the GDD 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 KU Bio 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 17,000 sq m site, which will include 6,500 sq m of lab space and one KU Bio 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 KU Bio unit will enable small-scale GMP manufacturing equipped with GE Healthcare’s single-use bio-manufacturing technologies, including 1,000 and 2,000L bioreactors, combined with Lonza’s automation platforms for clinical and early-commercial supply.
GE Healthcare is working with the GDD 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 UK, 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 excellence. With more than 20 successful FDA approvals for biologics, combined with international regulatory expertise, Lonza will now be able to offer the same high 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 their domestic companies 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.