Biosimilars manufacturing facility
A single-use bioprocessing technology-based KUBio™ modular biopharmaceutical manufacturing facility was officially inaugurated by JHL Biotech in May.
The facility is the largest in Asia and is located at Biolake Science Park in Wuhan, China.
The new facility will be used for the production of biosimilars and monoclonal antibodies (mAbs) for late-stage clinical trials, as well as commercial supply. The facility was developed by JHL Biotech in partnership with GE Healthcare Life Sciences.
JHL Biotech received authorisation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to begin monoclonal antibody biosimilar clinical trials in February.
The biopharmaceutical manufacturing facility has a total floor space of 2,400m² and is equipped with 2,000l capacity single-use bioreactors.
It is based on KUBio™ manufacturing solution, which is used for cell line development, process development, and cGMP manufacturing of late-stage clinical and commercial products. It will also offer process development and manufacturing services to JHL’s worldwide customers.
GE Healthcare Life Sciences and JHL Biotech reached an agreement to develop the modular biopharmaceutical facility at Wuhan in September 2013. As part of the agreement, GE Healthcare delivered KUBio a prefabricated cGMP-compliant facility and process solution, which is designed for scalable and cost-efficient manufacturing.
GE also provided bio-processing equipment to the building and was engaged in overall project co-ordination.
Construction of the facility was completed in 18 months, with mechanical completion achieved in February 2015.
The KUBioTM solution equipment was built in Germany in compliance with Chinese, European, and American regulatory standards and transported to Wuhan for assembly.
GE Healthcare supplied 62 completed modules in September 2015. The heating, ventilating, and air conditioning (HVAC) system; the clean room; most of the utility equipment; and all the piping necessary to run the plant were 90% pre-equipped.
The worldwide demand for biopharmaceuticals has been on the rise, including antibodies for the treatment of cancer and a new generation of innovative vaccines.
The biosimilars market in China was $44m in 2009, which is expected to grow up to $350m in 2019.
It is estimated that approximately 4.3 million new cases of cancer were reported in China in 2015. This prompted China’s State Council to develop 10-year action plan Made in China 2025 recommending the introduction of biological medicines and medical devices.
Biopharmaceutical start-up JHL Biotech is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity, and the China Development Industrial Bank.
The company is engaged in the development of low-cost medicines, as well as the research and development of new protein-based therapies and biosimilars.
It has two manufacturing facilities built in compliance with ICH cGMP regulations and standards.
Its facility in Taiwan is used for biosimilar pre-clinical and early-clinical phase R&D works, while the Wuhan facility in China works on the commercial-scale manufacturing of biologic therapies.
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