Catalent, MGC Partner in BiologicsBy
Catalent Pharma Solutions and Mitsubishi Gas Chemical Company, Inc. (MGC) 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.
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.
MGC Pharma was launched in April 2014 to provide proteins from mammalian cell cultures. MGC Pharma currently has analytical facilities in Niigata, Japan, and is establishing larger-scale cGMP manufacturing sites using GPEx mammalian cell lines and single-use bioreactor technologies.
Catalent Biologics has expressed more than 460 cell lines using the GPEx technology, with dozens of on-going clinical trials throughout the world and five products currently on the market. The company's facility in Madison, Wisconsin employs single-use technologies to offer cGMP production from 10 L to 1,000 L scale, and non-GMP production up to 250 L 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.
Source: Catalent Pharma Solutions