Award from KAKETSUKEN for albumin-recombinant bio-plant design
Ishikawajima-Harima Heavy Industries Co., Ltd. (IHI) has won award from The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)(*1) for an albumin-recombinant bio-plant design with the largest capacity in Japan. The design work consists of basic and construction (execution) designs. These will be developed for the engineering, procurement, construction, and trial operation of the facilities.
The IHI group has already completed a similar plant at Chitose, Hokkaido, for BIPHA Corporation in 1999. BIPHA is a joint venture of Mitsubishi Pharma Corporation (51% stake) and Nissho Corporation (49% stake). The new BIPHA albumin-recombinant plant is a follow-on to the previous plant.
IHI has constructed many pharmaceutical plants in the last 15 years. In August last year, IHI took over the pharmaceutical and industrial plant construction department of Niigata Engineering Co., Ltd. (dissolved last year). By the merger, IHI has added advantageous expertise and achievements to the business for pharmaceutical plant construction.
IHI has also boosted its business with technical cooperation with Foster Wheeler Corporation of the US. The US company is known worldwide as a leading engineering company in pharmaceutical plant construction, and has an experience in basic engineering of a similar plant for Delta Biotechnology Corp. that has concluded a technical license agreement with KAKETSUKEN for the albumin-recombinant process.
Several companies participated in the tender conducted by KAKETSUKEN, and IHI won the design competition due to its superior design presentation.
KAKETSUKEN will construct a facility to produce clinical test agents for the first stage, and invest in the following stages to develop the facility into full scale in ten years. The investment in the first through third stages will amount to over ten billion yen.
The first stage project includes construction of a two-story building with total floor area of 6,700m2. The basic design will be completed in November this year, and construction will begin in March 2004 and be completed in August 2005.
Upon completion of the third stage construction, the facilities will have a annual production capacity of one million vials containing 12.5g of the agent, the largest capacity in Japan.
KAKETSUKEN intends to build a clean and compact production facility to thoroughly meet the requirements of the Food and Drug Administration (FDA) of the US. This will permit KAKETSUKEN to supply the market with reliable products.
The biochemical engineering department of the IHI group is now studying stabilization of cultivation technology for commercialization and has cultivation equipment for tests to obtain scale-up data and information based on various conditions at the IHI Yokohama Works. With the test facility, IHI has carried out joint studies with pharmaceutical companies, and already completed 16 joint studies including those commissioned by pharmaceutical companies.
As one of the measures taken for environmental protection, IHI will use the IC reactor and waste liquid and sludge treatment equipment based on water-heat treatment technology for the test facility. The waste liquid treatment system can extract methane gas from treated materials and surplus sludge for reuse, thus forming a zero emission and recycling system.
The second order for albumin-recombinant plant engineering is significant for IHI. Japan's large demand for albumin at present depends upon imports, and the KAKETSUKEN project will increase the domestic supply volume of albumin.
(*1) The Chemo-Sero-Therapeutic Research Institute (KAKETSUKEN)
Established: December 26, 1945
Director General and Superintendent: Kyoji Uchino