In October 2015, Japanese pharmaceutical company Chugai Pharmaceutical announced its decision to build a plant for manufacturing antibody active pharmaceutical ingredients (APIs) at its existing Ukima Plant in Kita-ku, Tokyo.
The plant will enable the high-mix, low-volume production of antibody APIs for investigational drugs in late-stage clinical studies to initial commercial products.
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Construction of the facility began in January 2016 and is scheduled to be completed by December 2017. Operations are expected to begin by June 2019.
Reactors are expected to be installed at the plant by July 2018. Older facilities at the existing Ukima plant are currently being demolished.
Details of the Chugai Pharmaceutical antibody API manufacturing facility
The API facility will be situated on a 23,636m² (5.84-acre) site and will have a built-up area of 4,066m². The old and new facilities will have a total floor space of 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 Pharmaceutical’s capability to meet demand for initial commercial products in future.
It is also expected to support Chugai’s plans to obtain global top-class competitiveness by minimising the time between drug development and launch by allowing multiple drug candidates to be developed at the same time.
Technology at the Chugai Pharmaceutical antibody API manufacturing plant
The plant will be installed with six 6,000l capacity bioreactor tanks.
This will increase the site’s total capacity to 49,000l bioreactor tanks when combined with the existing Ukima plant, which has two 2,500l capacity bioreactor tanks for antibody API production and four 2,000l capacity bioreactor tanks for producing antibody APIs for investigational drugs.
Financing for the antibody API manufacturing plant
The total investment required for the plant’s construction is estimated at ¥37.2bn ($310m). Chugai invested ¥2.9bn ($25m) in the Ukima plant to double its antibody drug production capacity.
Contractors involved in the project
Kajima Corporation is in charge of the project’s general construction, while Hitachi is responsible for the manufacturing facilities.
Marketing commentary on Chugai Pharmaceutical
Chugai Pharmaceutical is a subsidiary drug manufacturer based in Tokyo, Japan, and 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 worldwide.
Chugai Pharmaceutical 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.
