JHL Biotech and Selexis SA Form Biologic Drug Development Alliance06.12.2013 11:00
JHL Biotech, Inc., a provider of biopharmaceutical process development and manufacturing services, and Switzerland-based Selexis SA, a provider of technologies for mammalian cell line development, announced today that they have signed a non-exclusive strategic agreement to provide biopharmaceutical customers a seamless solution for the development and cGMP manufacturing of biologic drugs. The alliance will have a special emphasis on delivering safe and high-quality biologics to the Chinese market.
The alliance leverages the strengths of the two companies and will allow biopharmaceutical customers to quickly go from drug candidate DNA to active pharmaceutical ingredient (API) into clinical development and commercialization. Selexis will provide the fully-documented, high-producing, and stable SURE CHO-M mammalian clonal cell lines, and JHL Biotech will provide process development and manufacturing that follows current good manufacturing practices (cGMP) at their facilities in Hsinchu, Taiwan and Wuhan, China. The Wuhan facility, when completed in early 2015, will be the largest mammalian manufacturing plant of its kind in China.
In its first joint effort, JHL Biotech and Selexis were able to rapidly develop and successfully transfer a biosimilar antibody product. Selexis generated the high performance SURE CHO-M™ cell line that is now undergoing JHL Biotech’s comprehensive process development. JHL Biotech is manufacturing the biosimilar drug at its recently-built, state-of-the-art facility in Hsinchu, Taiwan. The facility is outfitted with GE Healthcare’s innovative technology FlexFactory®, includes two 500L single-use bioreactors, and is the largest mammalian cell line plant in Taiwan.
“Biopharmaceutical companies now can turn to JHL Biotech and Selexis for a reliable, rapid process to get products to market in China and the rest of the world,” said Racho Jordanov, JHL Biotech’s CEO, Co-founder, and President. “Making world-class biologics more affordable just got easier through the partnership of JHL Biotech and Selexis.”
“We are especially pleased at how fast we were able to provide JHL’s customer a clonal cell line expressing over 5 g/L at Selexis,” said Dr. Igor Fisch, CEO, Selexis SA. “By seamlessly combining JHL Biotech and Selexis’ unique technologies and know-how, it is now possible to save our customers both time and money with their biologic development programs. Moreover, the JHL Biotech and Selexis alliance will allow biopharmaceutical companies to cost effectively develop safe biologic drugs for the Chinese market.”