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The development and manufacturing programs will benefit from the GPEx technology producing very stable and high yielding cell lines.
Under the agreement, UMN Pharma and its subsidiary UNIGEN, which is a contract manufacturer, will produce a number of biosimilars using Catalent’s GPEx cell lines. UMN Pharma, separately, will build an alliance of pharmaceutical companies for product development including clinical trials, marketing and sales. UMN Pharma plans to begin multiple biosimilar projects with their alliance companies for the Asian market on an ongoing basis.
“There are great synergies between UMN Pharma and Catalent in terms of technologies, business structure, speed and culture,” commented Masahiro Michishita, Executive Chairman of UMN Pharma. “Harnessing Catalent’s broad biologics development and cell construction expertise gives UMN Pharma a unique platform to grow our biosimilars business globally.”
Barry Littlejohns, Catalent’s Business Unit President, added, “This agreement will allow Catalent to continue to grow its biologics development and manufacturing interests of multiple biosimilars and NBEs, particularly in the Asian market. UMN Pharma’s ambitious expansion plans reflect Catalent’s strategy for growth in what we consider to be a key market.”
Hans-Joachim Rohe, President of Catalent Japan added: “We are very excited to offer a continuously expanding range of Catalent services to our customers in Japan. With the growing demand for Catalent’s GPEx technology we enforce our position as leading supplier of drug delivery solutions and expert services.”
Founded in 2004, UMN Pharma now has three manufacturing facilities in Japan focused on the development of influenza vaccines based on insect cells. Supported by the Japanese government, UMN Pharma currently has three 600L bioreactors for influenza vaccine production. In response to the emerging demand for influenza vaccines, also for new biological entities (NBEs) and biosimilars, it has commissioned two additional 21,000L units in Gifu, to be operational by 2013. UMN Pharma will then add another two 21,000L facility by 2016.
Catalent’s biologics group has expressed over 360 cell lines for clients, with dozens of on-going clinical trails throughout the world and two products utilizing the GPEx technology currently on the market. A new state-of-the-art facility with 500L and 1000L single use bioreactors for cGMP manufacturing will be opening in Madison, Wisconsin, USA in spring 2013.