Unigene has entered into a joint venture with Shijiazhuang Pharmaceutical Group Corporation (SPG), its subsidiary China Pharmaceutical Group (CPG) and NBP Pharmaceutical Company (NBP) for the setting up of R&D and manufacturing plants in China. Unigene announced the commencement of construction of the new facilities.
The plant is planned to be located across a land of area 215,000 sq ft, which has been provided by SPG in the Shijiazhuang economic and technology development zone, Hebei Province, China.
The combined capital investment for the project made by the two companies is estimated to be US$ 15 million. While Unigene would be making an initial cash contribution of US$ 900,000, the majority of the investment would be in the form of technology.
The facility is designed to comply with the GMP and GLP guidelines of the US FDA as well as the Chinese SFDA as also the ICH guidelines. The plant initially will be focussing on the development and production of osteoporosis treatments salmon calcitonin and parathyroid hormone, primarily for the Chinese market. The plant is planned to be completed in phases. The first is to be a four-storeyed building to be completed by end 2008. It will house facilities for molecular biology, fermentation, purification, pharmacology, analytical chemistry, formulation and pilot-scale production of biotechnology products. Subsequently, there will be facilities for peptide production and manufacture of oral and nasal finished formulation. Production and validation activities are expected to begin in 2009.
