Chugai Pharmaceutical Co., Ltd. plans to construct a new plant for manufacturing antibody-based active pharmaceutical ingredients (APIs) for a mix of high- and low-volume production for late-stage investigational drugs and initial commercial products at the company’s plant in Ukima, Japan, which is part of Chugai Pharma Manufacturing Co., Ltd., a manufacturing subsidiary of the company.

Chugai is planning the manufacturing expansion in response to anticipated demand from its drug development efforts. The company has a strategic alliance with Roche, which owns approximately 60% of Chugai, for drug development. In 2012, Chugai established a research laboratory in Singapore, Chugai Pharmabody Research Pte. Ltd. (CPR), focusing on drug discovery research applying its proprietary antibody engineering technologies. Furthermore, Chugai has adopted various measures to maximize the value of drug candidates arising from its research, such as the amendments to the out-licensing agreement of Chugai products to Roche and the establishment of the Translational Clinical Research Division.

Since 2013, Chugai has had an ongoing investment of 2.9 billion yen ($76 million) to double anitbody-based production capacity for investigational drugs beginning from 2013 to 2015 at the Ukima plan. In addition to that investment, the company made a decision to invest for a new production plant API antibody manufacturing antibody API to meet the demand of initial commercial products in the future for both low-volume and high-volume drugs.

Chugai currently has several antibody projects under clinical development applying its proprietary innovative antibody engineering technologies. We are also actively conducting drug discovery research for antibody drugs at our domestic laboratories and CPR, and have several drug candidates close to the clinical phase. In order for us to promptly conduct simultaneous clinical development for these projects, we need to accommodate high-mix low-volume production of multiple investigational drugs,” said Dr. Hitoshi Kuboniwa, senior vice president and general manager of the Pharmaceutical Technology Division. “It is very important to organize the supply system from the late stage of clinical development to realize a fast commercialization in order for us to survive the severe competition in drug development. The research center for pharmaceutical process development is also located at the Ukima Office. Having technology development and production at a single site will enable increased efficiency in production processing.”

With this capital investment, six 6,000-liter bioreactor tanks will be newly installed. Combined with the existing two 2,500-liter tanks and four 2,000-liters tanks, the Ukima Plant will have a total capacity of 49,000-liter bioreactor tanks, with a consistent system from process development to production of antibody API of investigational drugs in late-stage clinical studies and initial commercial products at one site. Construction is scheduled to begin in January 2016, and the demolition of old facilities is currently underway. The total amount for this capital investment is 37.2 billion yen ($308 million). 

Source: Chugai Pharmaceutical