Kaneka begins a continuous GMP manufacturing

| By | GMP Standards, Pharmaceutical Manufacturing

Kaneka Corporation (Japan) have installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore 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 designed 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 in 2017, and we expect to apply this continuous manufacturing infrastructure to various Regulatory Starting Material (RSM), Intermediate, and API projects, including targets requiring GMP production.

Kaneka Corporation is a Japanese international chemical manufacturing company founded in 1949.

SOURCE: prnewswire
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.