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Catalent, Zhejiang Hisun Pharma to collaborate on biosimilar development

Monday, April 14, 2014

Catalent Pharma Solutions, a global provider of development solutions and advanced delivery technologies for drug, biologic and consumer health products, has signed an agreement with Zhejiang HISUN Pharmaceuticals to provide HISUN with a broad range of biosimilar cell lines, using Catalent’s proprietary GPEx technology for the Chinese market. The development and manufacturing programs will benefit from the GPEx technology’s proven capability to produce very stable and high-yielding cell lines.

HISUN will produce a broad range of biosimilars, including infliximab, adalimumab and alemtuzumab, using Catalent’s GPEx cell lines.

Barry Littlejohns, president of Catalent’s Advanced Delivery Technologies business, said, “We are keen to grow our biologics and development customer base throughout the Asia-Pacific region and intend to extend our global leadership in advanced delivery technologies and expert services throughout the region. We believe that the GPEx technology will enable HISUN to bring its products to market faster.”

Haibin Wang, senior vice president of HISUN, said, “We constantly evaluate technologies that can accelerate the progress of therapeutics for our patients. Catalent’s GPEx technology enables HISUN to bring its current bioreactor capacity to full operation, at a faster pace. We are excited about this collaboration because it heightens the quality and efficiency of our products’ development and enriches our pipeline products.”

In 2013, Catalent announced two joint ventures in China for its Softgel Technologies and Clinical Supply Solutions businesses to support customers within the Asia-Pacific region. Since then, the company has completed the acquisition of a majority share in Haining-based, privately held Zhejiang Jiang Yuan Tang Biotechnology, and continues to invest in people and equipment to produce Catalent R P Scherer softgel technologies. Catalent’s new 31,000-square-foot facility in Shanghai opened in November 2013 and has become the first site in China to provide end-to-end solutions for clinical trial supplies.

Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency, getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production. Catalent also has exclusively licensed the SMARTag advanced antibody-drug conjugate technology and completed construction of its new single-use Biomanufacturing Center of Excellence in Madison, Wis.

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