Kaneka officially starts continuous manufacturing in GMP condition
―Commercial production utilizing flow chemistry to begin June 2018 at Kaneka Singapore. ―
July 23, 2018
Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Mamoru Kadokura) installed continuous manufacturing equipment to be applied to small molecule pharmaceutical products at Kaneka Singapore Co. (Pte.) Ltd, (Headquarters: Singapore; President: Kazuhiko Yamada) and have started commercial production in GMP*1 condition June 2018.
In small molecule pharmaceutical market, trend is moving towards widely varied smaller volumes. In order to address these changes, new efficient production technology is required. Continuous manufacturing, or Flow Chemistry, is a manufacturing technology that achieves spontaneous reaction to charge raw materials step-by-step into reaction tubing and presents an easy, safe and convenient approach to manufacturing, including reactions that may require tough or dangerous conditions under typical batch reaction. This new equipment is a unique, Kaneka designed, reactor that allows diversity of application through the ability to select the relevant parameters of the reaction tubing and provides the highest performance of reactions. Kaneka Singapore has been qualified as a manufacturer from the US FDA*2 in 2017, and we expect to apply such continuous manufacturing infrastructure to various products, including targets requiring GMP
Kaneka has capability from process development to commercial production with excellent quality assurance, and this new technology will enhance our business in small molecule pharmaceutical. With biological pharmaceutical activities, we now aim to expand our business in Health Care field.
*1 Abbreviated name of Good Manufacturing Practice, the guidelines for production
and quality assurance to ensure that products are consistently high in quality.
Authorities like Food and Drug Administration in US recommends, and
manufacturers need to consider it in all the works from reception of
raw materials to release of products.
*2 Abbreviated name of Food and Drug Administration. It is an agency within the
Department of Health and Human Services in US and has responsibility
for regulating the manufacturing, marketing, and distribution of
pharmaceutical products, foodstuff products, and so on.
＜Kaneka Singapore Co. (Pte.) Ltd.＞
Representative: CEO, Kazuhiko Yamada
Paid-in Capital: 16million Singapore dollars
Business field: Sales and manufacturing of pharmaceutical products.