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news.Biopharmaceutical firm JHL Biotech (JHL) has opened the world’s first KUBio biopharmaceutical manufacturing facility with single-use bioprocessing technology in Wuhan, China.
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JHL will use the KUBio manufacturing solution delivered by GE Healthcare to manufacture biosimilars1 and monoclonal antibodies (mAbs) for late-stage clinical trials and commercial supply. The facility will also provide process development and manufacturing services for JHL’s global customer base.
JHL and GE Healthcare partnered to complete the construction of the facility in just 18 months using GE’s KUBio manufacturing solution. KUBio is a prefabricated cGMP-compliant facility and process solution designed for scalable and cost-efficient manufacturing.
The biosimilars market is expected to grow significantly in China, reaching approximately USD 350 million in 2019, up from USD 44 million in 20092.
Local manufacturing in China is a more affordable way to provide modern therapies for deadly diseases like cancer, which is the leading cause of death in China.
In 2015, approximately 4.3 million new cancer cases were reported in the country. China’s State Council’s 10-year action plan "Made in China 2025" recognizes biological medicines and medical devices as one of its key industrial focus areas.
Racho Jordanov, CEO and co-founder of JHL Biotech commented, "JHL Biotech’s mission is to make quality medicines affordable to more people, and we believe one of the greatest areas of need is in Asia. It was important to us to establish our scale-up manufacturing capacity in Asia with a manufacturing facility in China capable of producing biologics to a world-class standard.
"JHL’s new facility in Wuhan has the same standardized GE FlexFactoryTM technology as our existing site in Taiwan, which allowed us to quickly scale up to a capacity of 2,000 litres. JHL Biotech now has the largest volume of single-use cell culture capacity in Asia with the opening of our new facility in Wuhan."
"GE Healthcare’s expertise in project management and delivery has been key in completing the factory in just 18 months, exceeding our demanding timelines and enabling us to accelerate our plans to produce next-generation biotherapeutics locally."
Advances in diagnostics are leading to an improved capability for biopharmaceuticals to precisely and effectively address challenging diseases. Of the top 10 therapeutics on the market today, seven are biopharmaceuticals5. Their complex nature demands expertly developed processes to ensure efficient manufacture.
John Flannery, President and CEO, GE Healthcare commented, "We have been working closely with our customers and observing market needs carefully and, as a result, have created an innovative solution improving access to biopharmaceuticals all over the world. We are providing a complete manufacturing solution faster than anyone else, which means that JHL is able to enter the market with high-quality pharmaceuticals responding to a real market need in record time."