Topic: Continuous processing
While the FDA knows API production has mostly moved out of the U.S., it does not know how much is being produced in China or elsewhere.
GlaxoSmithKline has opened continuous manufacturing operations in Singapore that will make products faster, with less cost and less waste.
The FDA has issued guidance on continuous manufacturing and is allocating $58 million to move forward advanced manufacturing processes.
Lonza and Portola are hard at work; the FDA goes after a compounder; and an Indian biotech opts for continuous manufacturing.
Boehringer Ingelheim will consolidate the R&D and manufacturing of complex solids into a $100 million facility it is building in Germany.
Cambrex has completed installation of multiple continuous flow reactor platforms at its facility in High Point, North Carolina.
CDMO Cambrex has installed continuous flow manufacturing technology at a site in Sweden where it will make intermediates for AstraZeneca.
CordenPharma has joined the small but growing cadre of pharma companies adding continuous manufacturing to their mix of manufacturing operations.
Scientists at MIT have a prototype of a continuous manufacturing device that is so small it might be used by pharmacies to produce their own generic drugs.
Now that the FDA has for the first time approved a company switching production of a drug from batch to continuous manufacturing, the agency is inviting others to get on board with the process.