Somerset, NJ & Tokyo, Japan – January 19, 2015 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Mitsubishi Gas Chemical Company, Inc. (MGC), today jointly announced that they have entered into a partnership agreement to co-promote Catalent’s proprietary GPEx® technology in the Asian market. MGC is a major chemical engineering company, and recently established a subsidiary, MGC Pharma Co., Ltd., to provide contract development, and clinical and commercial manufacturing of biologics in Asia. Through the collaboration, MGC Pharma’s customers will benefit from GPEx technology’s production of stable and high yielding cell lines, while bringing their development programs to market faster.
Under the agreement, Catalent will engineer the cell lines and carry out development, and MGC Pharma will provide Phase III and commercial manufacturing. Additionally, MGC and MGC Pharma will be able to offer biosimilar cell lines produced using GPEx technology to pharmaceutical partners for further product development and commercialization.
“There are great synergies between MGC Pharma and Catalent in terms of technologies and business structure,” commented Masami Orisaku, President of MGC Pharma. “MGC and Catalent will complement each other in the growth of our biologics businesses and in supporting our customers’ requirements in the Asian market.”
Mike Jenkins, Vice President of Business Development, Catalent Biologics, Asia Pacific, added, “This agreement will allow Catalent to continue to grow its biologics development and manufacturing interests of multiple NBEs and biosimilars, particularly in the Asia Pacific market. The collaboration with MGC Pharma fits Catalent’s strategy for growth in what we consider to be a promising region.”
Tadahiro Matsumura, President of Catalent Japan commented: “We are very excited to offer not only reliable softgel business solutions but also superior biologics solutions to our customers in Asia. This collaboration reinforces our position as a leading supplier of advanced drug delivery technologies and development solutions.”
MGC Pharma was launched in April 2014 in response to emerging social needs for medical proteins obtained solely from mammalian cell cultures. MGC Pharma currently has analytical facilities in Niigata, Japan, and is establishing larger scale cGMP manufacturing sites utilizing GPEx mammalian cell lines and single-use bioreactor (SUB) technologies.
Catalent Biologics has expressed over 460 cell lines for clients using the GPEx technology, with dozens of on-going clinical trials throughout the world and five products currently on the market. The company’s state-of-the-art facility in Madison, WI employs single-use technologies to offer flexible, cGMP production from 10L to 1,000L scale, and non-GMP production up to 250L scale. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development laboratories, and separate microbiology and Quality Control functions.