Japanese firm Chugai Pharmaceutical is to construct a new JPY37.2bn (approximately US$310m; €280m) plant for manufacturing antibody active pharmaceutical ingredients (API) in Tokyo.
The plant will produce high-mix, low-volume, late-stage investigational drugs and initial commercial products at the Ukima plant of Chugai Pharma Manufacturing, a manufacturing subsidiary of the company.
Chugai has been conducting new drug development under a strategic alliance with F. Hoffman-La Roche. In 2012, it established a research laboratory in Singapore, Chugai Pharmabody Research (CPR), focused on drug discovery research applying its proprietary antibody engineering technologies.
As a result of these initiatives, the need to continuously generate innovative drug candidates is expected to increase. Chugai has therefore reinforced its production capacity for investigational drugs, and a capital investment of JPY2.9bn has been ongoing since 2013 at the Ukima plant, aimed at doubling its production capacity for antibody drugs in order to accommodate the simultaneous development of drug candidates.
Chugai will invest in the new plant in Tokyo to increase its capacity to manufacture antibody API to meet the demand of initial commercial products in the future.
Having technology development and production at a single site will enable increased efficiency in production processing
'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 Hitoshi Kuboniwa, Senior Vice President and General Manager of the Pharmaceutical Technology Division.
'It is very important to organise the supply system from the late stage of clinical development to realise a fast commercialisation in order for us to survive the severe competition in drug development. The research centre 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.'
As part of this new capital investment, six 6,000L bioreactor tanks will be installed at the Ukima plant. Combined with two existing 2,500L tanks and four 2,000L tanks, the plant will have a total capacity of 49,000L 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 start in January 2016, with operation scheduled for June 2019.
