API manufacturing gets makeovers

If API manufacturing does find its way out of Asia, it may want to stop in the UK. Engineers at the University of Leeds have developed a technology to improve the formation of drug crystals in chemical reactors, promising big improvements in manufacturing efficiency.

The technology relies on self-assembled monolayers, which are bound to metal substrate within ordinary reactors, to produce crystals in the intended product form. The method yields crystals having the desired shape and particle structure, avoiding the high-ticket problems of polymorphism. Researchers are now preparing to test the concept on an industrial scale.

API makeovers are also underway at GlaxoSmithKline and other drug companies, driven by--of all things--corporate sustainability initiatives. GSK has a 2015 waste-reduction target for its plants of  30 kg for each 1kg of API, down from 100kg in 2005.

The Financial Times reports that the big pharma effort to reach the target involves changing and reducing the number of chemical steps required, cutting the volume of solvents, and switching to continuous manufacture of a single drug to remove the wastage involved in stopping, changing and restarting batches of different products. 

- here's the University of Leeds announcement
- see the FT article

Suggested Articles

A biotech that worked with a nutritional products maker on the API for its clinical-stage radiation drug, is buying all of the manufacturing know-how.

Merck KGaA is selling a manufacturing site and its Allergopharma allergy drug business as it focuses on newer meds.

In a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.