Kaneka officially starts continuous manufacturing under GMP

Food and Healthcare Press Releases Tuesday August 14, 2018 15:18
TOKYO--14 Aug--PRNewswire/InfoQuest
Commercial production utilizing flow chemistry began June 2018 at Kaneka Singapore

Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Mamoru Kadokura) have installed continuous manufacturing equipment to be applied to pharmaceutical products at Kaneka Singapore Co. (Pte.) Ltd, (Headquarters: Singapore; President: Kazuhiko Yamada) 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. Our equipment is a unique, 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 *1 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 *2 production.

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

*1 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.

*2 Abbreviated name of Good Manufacturing Practice, the recommended guidelines and minimum requirements to ensure that products are consistently high in quality.
< Kaneka Singapore Co. (Pte.) Ltd. >
Representative: CEO, Kazuhiko Yamada
Paid-in Capital: 16 million Singapore dollars
Headquarter: Singapore
Establishment: 1979
Business field: Sales and manufacturing of pharmaceutical products.
Contact:
Alan Walker
VP Pharma, Kaneka Americas Holding
(212) 705-4392
Photo - https://mma.prnewswire.com/media/729329/Kaneka_Press_Release_Image.jpg
Logo - https://mma.prnewswire.com/media/635217/Kaneka_Corporation_Logo.jpg

Latest Press Release

Accor Pattaya Blood Donation #3/2019

On Tuesday 17th, September 2019, Hotel Baraquda Pattaya - MGallery and Mercure Pattaya Hotel attended to Accor Pattaya Blood Donation #3/2019 at Veranda Resort Pattaya Na Jomtien - MGallery, MM Meeting Room. The event started at 10.00 a.m. to 02.00 p.m....

Tresiba(R) Showed an Overall Lower Risk of Hypoglycaemia and Significantly Lower HbA1c When Compared to Insulin Glargine U300 in People With Type 2 Diabetes

According to new data from the CONCLUDE head-to-head trial, Tresiba(R) (insulin degludec) showed an overall lower risk of hypoglycaemia, also known as a hypo or low blood sugar, at a significantly lower HbA1c, compared with insulin glargine U300 in...

BookDoc, partners it#s way to being Southeast Asia#s Next Generation Healthcare Ecosystem is looking to raise Series A from Strategic partners

This year crosses 100 strategic partnerships in over 20 cities across Malaysia, Singapore, Indonesia, Thailand and Hong Kong. Since commenced operations in 2015, BookDoc has grown exponentially with four consecutive years of over 450% annual growth rate...

United Nations Political Declaration on Universal Health Coverage Finally has Some Teeth

FDI World Dental Federation (FDI) welcomes the long overdue commitment to strengthening oral health in the UN Political Declaration on Universal Health Coverage (UHC). The declaration will be officially adopted by world leaders at the UN High-Level...

Ozempic(R) Offers Superior Reductions in HbA1c and Body Weight Compared to Both Victoza(R) and Canagliflozin in People With Type 2 Diabetes

Novo Nordisk announced today the results from two Ozempic(R) (once-weekly semaglutide 1.0 mg) head-to-head Phase 3 clinical trials, SUSTAIN 8 and SUSTAIN 10, which showed: - Ozempic(R) was superior to treatment with the SGLT-2 inhibitor canagliflozin...

Related Topics