Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/695748
26 | JULY 2016 | GENengnews.com | Genetic Engineering & Biotechnology News JHL Biotech, a biopharma based in Taiwan, recently opened the world's frst KUBio™ modular biopharmaceutical manufactur- ing facility with single-use bioprocessing technology. JHL will use the KUBio, which was delivered by GE Healthcare and sited in Wuhan, China, to manufacture biosimi- lars and monoclonal antibodies (mAbs) for late–stage clinical trials and commercial supply. The facility will also provide pro- cess development and manufacturing ser- vices for JHL's global customer base. To learn more about KUBio, GEN spoke to Jan Makela, general manager for bioprocess, GE Healthcare's Life Sciences business. GEN A modular factory is something new for GE's bioprocess-related product line. What led the company to investigate this new concept, develop it, and now place it in China? Mr. Makela KUBio was launched in Septem- ber 2012 to address the increasing world- wide demand for biopharmaceuticals. Initial modules are confgured for the manufacture of monoclonal antibodies. The speed and fexibility of single-use components is now well-recognized across the industry, and GE Healthcare's know-how in the sector and global footprint makes us ideally placed to harness this potential and package it for rap- id deployment wherever a customer requires. This ease of global access and speed of installation led JHL to select KUBio for its site in Wuhan. Its reason for manufacturing in China is to produce quality, affordable biopharmaceuticals for the region to meet a currently unmet need. GEN What motivated JHL to purchase the KUBio factory? M r. M a ke l a According to JHL Biotech's CEO, Racho Jordanov, JHL was looking to establish manufacturing capacity in Asia with a facility capable of producing biologics to a worldclass standard. As well as the speed of construction and single-use components of a KUBio, JHL selected GE's modular solution due to its standardized quality, which is of a repeatable cGMP-compliant standard. KU- Bio is ftted with FlexFactory™ technology, which was of particular interest to JHL Bio- tech, to complement its FlexFactory in Tai- wan. JHL is looking to work with GE again to add a second KUBio as well as fll-fnish plant to the Wuhan site. The scalability of the technology and standardization of the facili- ties will provide seamless tech-transfer. As an early-stage company, JHL Biotech also beneftted from GE's complete proj- ect management, acting as a single point of contact for JHL. Jordanov appreciated GE Healthcare's expertise in project manage- ment and delivery as being key in completing the factory in just 18 months, exceeding de- manding timelines and enabling JHL to ac- celerate its plans to produce next-generation biotherapeutics locally. JHL Biotech now has the largest volume of single-use cell culture capacity in Asia with the opening of the new facility. GEN What are the main advantages of having such a facility on site? Mr. Makela GE Healthcare's KUBio is a pre- fabricated facility for monoclonal antibody production that is constructed, assembled and fully ftted-out in 14–18 months, which is an accelerated timeline that is signifcantly faster than traditional stick-built methods. KUBio also offers a suite of services in ad- dition to the facility including: fnancial guidance, bioprocessing equipment, project coordination, and product development and qualifcation and repair services. The use of GE's FlexFactory platform means that many elements can be pre-qual- ifed offsite, and that this can be done in parallel with the construction of the facility itself. Also, the manufacture of the modules that make up the facility can be done in par- BD ™ CHO CD Medium and Feed Kit BD 7 Loveton Circle Sparks, MD 21152 bdbiosciences.com/advbio © 2016 BD. BD, the BD Logo and BD OneFeed are trademarks of Becton, Dickinson and Company. 23-18518-00 RIGHT NUTRIENTS? Think your cells are getting the It's time to make a change. BD CHO CD Medium and Feed Kit, and the BD OneFeed supplement are prototypes in the BD Preview Series. Larger quantities are available through BD Custom Products Services. Specifcally designed for CHO cells, BD ™ CHO CD Medium and Feed Kit, rich in carbohydrates, amino acids, and vitamins, gives you another option when it comes to supplying your cells with the nourishment they need to thrive. Supporting the direct adaptation of CHO cells, BD's newest chemically defned, animal-free medium can be used in both batch and fed-batch culture, while the versatile BD OneFeed ™ medium supplement is a chemically defned, animal-free, protein-free feed shown to enhance protein production when used in a variety of commercially available media. To order a BD Preview Pak of the BD CHO CD Medium and Feed Kit or the BD OneFeed supplement, please call 877.362.2700 or go to bdbiosciences.com/go/cho-cd. KUBio Modular Manufacturing Solution Is Based on Single-Use Bioprocessing Technology JHL Biotech Opens Biosimilars Facility BIOPROCESSING Perspectives