GE Healthcare delivers world’s first modular manufacturing solution based on single-use bioprocessing technology in just 18 months
HHM Global/Press releases/-JHL Biotech (JHL), a biopharmaceutical company, opened the world’s first KUBio™ biopharmaceutical manufacturing facility with single-use bioprocessing technology at a ribbon-cutting ceremony in Wuhan, China today.JHL will use the KUBio manufacturing solution delivered by GE Healthcare to manufacture biosimilars(1) 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(2), up from USD 44 million in 2009 . 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(3) 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(4).
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 biopharmaceuticals(5). 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.”
(1) FDA, 2015: Biosimilars are a type of biological product that are licensed (approved) by regulatory authorities because they are highly similar to an already-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.
(2) Frost & Sullivan, Jan 2014: “Analysis of the Global Biosimilars Market”
(3) American Cancer Society, 2016: Cancer in China
(4) China Daily, 2015: 'Made in China 2025' plan unveiled
(5) GEN, 2015: The Top 25 Best-Selling Drugs of 2014 (a subscription required)
About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information about GE Healthcare, visit our website at www.gehealthcare.com .
About JHL Biotech
JHL Biotech Inc. (Stock Code: 6540.TWO) is a biopharmaceutical startup founded by a group of industry veterans with deep experience in pharmaceutical development and operations. JHL is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity, and the China Development Industrial Bank. JHL Biotech’s mission is to provide the world with low-cost medicines of exceptional quality. JHL is focused on research and development of new protein-based therapies and biosimilars.JHL Biotech has two world-class facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards. The JHL Center of Excellence in Taiwan does biosimilar pre-clinical and early-clinical phase R&D work. JHL’s facility in Wuhan, China will do commercial-scale manufacturing of biologic therapies. This infrastructure gives JHL the unique ability to manufacture its own product and execute contract orders for select clients. For more information, please visit www.jhlbiotech.com .
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