Manufacturing Technology Association of Biologics

This time,Establishment of “Manufacturing Technology Association of Biologics” was approved from the Ministry of Economy. This association is the technical research association to put a next generation creation foundation technical development (the manufacturing technology which are the next generation antibody medicines with which I fit in in international standard) project of medical supplies for individualized medical treatment of the Ministry of Economy, Trade and Industry (hereinafter, this project) into effect.

　Until now, we have taken advantage of the characteristics of artificial chromosome vector technology, such as the stability of gene expression and the ability to control the expression level, we installed the gene of interest in artificial chromosome vector, prepared micronucleus cells, We transfected into a cell line and have many achievements in gene stable expression cell line production.

　This next generation biopharmaceutical manufacturing technology development belongs to the development process of cell improvement technology and it is greatly expected to utilize our technology which we have offered to many customers so far. We will further develop this technology and we would like to provide cell technologies that will continue to contribute to the diverse needs of our customers.

Manufacturing Technology Association of Biologics（MAB）Overview

Date of Establishment：September 26, 2013
Chairman：Toshiaki Higashihara (President & CEO, Hitachi, Ltd.)
Associate Members：Asahi Kasei Medical Co., Ltd., ALPS ELECTRIC CO., LTD., ABLE Corporation,
OSAKA SODA Co., Ltd., KANEKA CORPORATION, Kyoto Monotech Ltd.,
chromocenter Inc., SHIMADZU CORPORATION, GL Sciences Inc.,
JNC CORPORATION, JX Nippon Oil & Energy Corporation,
JSR Life Sciences Corporation, Sharp Corporation, Sumitomo Electric Industries, Ltd.,
Sumitomo Bakelite Co., Ltd., DAIICHI SANKYO COMPANY, LIMITED,
Chitose Laboratory Corp., Tokyo Chemical Industry Co., Ltd., TOSOH CORPORATION,
TOTO LTD., Nippi, Incorporated, Hitachi, Ltd., FUJIMORI KOGYO CO., LTD.,
Mitsubishi Chemical Corporation, Yokogawa Electric Corporation, YMC CO., LTD.,
Japan Blood Products Organization (General Incorporated Association),
Japan Bioindustry Association (General Incorporated Foundation),
Kihara Memorial Yokohama Foundation for the Advancement of Life Sciences (Public Interest Incorporated Foundation),
National Institute of Advanced Industrial Science and Technology (National Research and Development Agency),
Tokushima University, Kobe University, Kyushu University, Yamaguchi University.
(including: 26 Companies, 3 Organizations, 1 National Research and Development Agency and 4 Universities)
Project cost： 3,200,000,000 yen in fiscal year 2013[the outside funds: 2,650,000,000 yen　and due; of 570,000,000 yen] The overview of business：Research and development of the manufacturing technology which are the next generation antibody medicines with which I fit in in international standard

○The purpose of union establishment
　Development of advanced and highly efficient next-generation manufacturing technology that combines companies, universities and public research institutes involved in the manufacture of biopharmaceuticals in Japan, manufacturing complicated and multifunctional biopharmaceuticals (antibody drugs) conforming to international standards I do.

○Directionality of practical use

①Development of productive cell line construction technology
②Development of high-performance cell culture technology
③Development of advanced downstream technology
④Development of advanced quality evaluation
⑤Development of virus-security control technology
⑥Establishment of next generation platform technology adopted with international standards.

○When is the point of commercialization
　For commercialization and practical application as a brand in pharmaceutical manufacturing, drug discovery / production technology research field through developed technology, we will promptly commercialize after the end of the subsidy period.