API manufacturing plant
Chugai Pharmaceutical announced its decision to construct a new plant for manufacturing antibody active pharmaceutical ingredients (APIs) at the existing Ukima Plant located in Kita-ku, Tokyo, Japan, in October 2015.
The plant will enable high-mix low-volume production of antibody APIs for investigational drugs in late-stage clinical studies to initial commercial products.
Its construction began in January 2016 and is scheduled to be completed by December 2017, while operations are expected to commence by June 2019.
Reactors are expected to be installed by July 2018. Demolition of old facilities at the existing Ukima plant is currently underway.
The new API facility will be situated on a 23,636m² (5.84 acre) site and will have a built up area of 4,066m². Combined floor space of the old and new facilities will be 45,780m², on completion of the project.
The manufacturing plant will produce antibody APIs, injection products and investigational drugs for clinical studies. It will expand Chugai’s capability to meet demand for initial commercial products in the future.
It is also expected to support Chugai’s plans to obtain global top-class competitiveness by minimising the time required from the development to launch a new drug by introducing simultaneous development of multiple drug candidates.
The new plant will be installed with six 6,000l capacity bioreactor tanks.
It will enhance the total capacity of the site to 49,000l bioreactor tanks together with the existing Ukima plant, which has two 2,500l capacity bioreactor tanks used for antibody API production and four 2,000l capacity bioreactor tanks used for the production of antibody APIs for investigational drugs.
Total investment for the construction of the new plant is estimated to be ¥37.2bn ($310m). Chugai invested ¥2.9bn ($25m) at the Ukima plant to double its antibody drug production capacity.
Kajima Corporation is in charge of general construction of the project, while Hitachi is responsible for the manufacturing facilities.
Chugai Pharmaceutical is a subsidiary drug manufacturer headquartered at Tokyo, Japan and is controlled by Roche Holding. The company is engaged in biopharmaceutical and molecular-targeted drug discovery to create innovative drugs.
It also manufactures and commercialises pharmaceutical products in Japan and internationally.
The company develops product candidates in the areas of oncology, bone and joint diseases, autoimmune diseases, central nervous system, and other diseases. Its oncology product portfolio includes Avastin, Herceptin, Rituxan, Xeloda, Tarceva, Neutrogin, Perjeta, Kadcyla, and Alecensa.
Joint disease products produced by the company include Actemra, Suvenyl, Edirol, Alfarol, and Bonviva, while renal disease products include Mircera, Oxarol and Epogin.
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