Kaneka officially starts continuous manufacturing under GMP

Japan based Kaneka Corporation has installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore Co. (Pte.) Ltd with commercial production under cGMP already underway as of June 2018.

In the field of small molecule pharmaceutical products, the recent demands have begun to  trend toward an increased number of more diversified and smaller volume targets. With these changes, more efficient production technology is needed to address the broad range of targets now required.

Continuous manufacturing, or Flow Chemistry, is a manufacturing technology that allows the introduction  of raw materials with little to no operator exposure and presents an  easy, safe and convenient approach to manufacturing, including reactions that may require tough or dangerous conditions under typical batch reaction conditions.

Kaneka has designed a reactor that allows diversity of application through the ability to select the relevant parameters of the reaction tubing based on laboratory and scale-up research providing the highest performance of reactions. Kaneka Singapore has been qualified as a manufacturer from the US FDA  and it expects to apply this  continuous manufacturing infrastructure to various Regulatory Starting Material (RSM), Intermediate, and API projects, including targets requiring GMP production.

Kaneka has capability from process development to commercial production with excellent quality assurance, and it now aims to expand the solution services in the Health Care business field utilizing this new technology.

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