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Agreements

Date: 2013-12-03

Type of information: Collaboration agreement

Compound: cGMP manufacturing services

Company: Selexis (Switzerland) JHL Biotech (Taiwan)

Therapeutic area: Technology - Services

Type agreement:

collaboration

Action mechanism:

Disease:

Details:

* On December 3, 2013, JHL Biotech, Inc., a provider of biopharmaceutical process development and manufacturing services, and Switzerland-based Selexis, a provider of technologies for mammalian cell line development, 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.

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Is general: Yes