Lonza and GE Healthcare are developing a new biologics facility in Guangzhou, China.
The biologics facility will be based on GE Healthcare’s KUBio platform. It will provide development and manufacturing services for drugs in clinical and commercial stages of development.
The project is part of a larger initiative between Guangzhou Development District (GDD) and GE Healthcare to support the manufacturing of biopharmaceuticals in China. Lonza signed a memorandum of understanding (MoU) with GDD for leasing the site in December 2018.
The new facility is expected to be operational by 2020 and will serve as a strategic base for Lonza in China. It will enable the company to respond to the growing needs for high-quality contract development and manufacturing organisation (CDMO) services in the country.
The project is expected to generate 160 new jobs in the region.
To be developed on a 17,000m² site, Lonza’s new facility will include 6,500m² of laboratory space and a KUBio facility. It will provide biologics development and manufacturing services.
The labs will utilise Lonza’s proprietary platforms for cell-line construction, process development, cell banking and the GS gene expression system®. They will also house pilot labs.
The KUBio unit will utilise GE Healthcare’s single-use biomanufacturing platform along with Lonza’s automation platforms for manufacturing clinical and commercial biologics batches. It will also house 1,000l and 2,000l bioreactors for small-scale good manufacturing practice (GMP) production.
KUBios are pre-fabricated biomanufacturing facilities that house bioprocessing manufacturing equipment. It can be used to produce biologics such as monoclonal antibodies (mAb) or vaccines.
The KUBio platform is said to be cost-effective compared with traditional facilities and can be set up for production within 18 months. KUBios are also claimed to utilise comparatively less water and energy.
The Guangzhou biologics facility will use Lonza’s cell line selection process, which is devised to recognise the clones that are highly productive and deliver current good manufacturing practice (cGMP) material within 14 months of receiving DNA sequence.
The process reduces the production cost of biopharmaceuticals and produces a high yield of product with the desired critical quality attributes.
The facility will also utilise Lonza’s GS gene expression system®, which produces standard format monoclonal antibodies, bispecifics, novel glycoproteins, and other complex molecules.
The system utilises a viral promoter and extraction to enable accelerated development of high-yielding and stable mammalian cell lines.
A baby boom in the 1970s in China has led to the population facing a range of chronic health issues such as cancer and autoimmune diseases. Biologics are one of the most effective treatments for such diseases, although their availability in the country is limited.
The new facility will enable Lonza to tap into the growing demand for biologics in China. The country has restructured its regulation of the drug industry by enabling license and filing holders to establish their own manufacturing/distribution operations in the country.
The State Council implemented a drug marketing authorisation holder (MAH) programme in 2016 as a preliminary programme. Under the programme, research organisations and individual Chinese citizens can hold marketing authorisation without owning any manufacturing equipment.
The state’s policies are promoting domestic companies and multi-nationals to set up manufacturing in China and making biologics more accessible to patients and healthcare providers.
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