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The US FDA is working with GEA to validate continuous manufacturing as the pharma industry enters “the start of the end” for batch manufacturing, according to GEA.
On the second day of AAPS in San Antonio, Texas, in-Pharmatechnologist.com met up with GEA Process Engineering to discuss how the industry has been slow to adapt to continuous manufacturing and how its collaboration with the US Food and Drug Administration (FDA) may lead the way forward.
“This is a work in progress,” said Michael Fazio from the firm’s Powder Processing Division. “GEA has a project with a firm in Boston and is implementing the first of their four ordered systems, and the validation – the regulatory part of the project – is sort of a cooperation between the client, us and the FDA.”
“The FDA has been pushing the industry towards continuous manufacturing for a long time,” he added. “Other industries have been doing continuous [for a while] but pharma is a bit behind.The FDA supports it and is therefore involved in the regulatory part of getting systems validated.”
The Agency has been vocal about making the shift for a number of years with current Director of the Centre for Drug Evaluation and Research (CDER) Janet Woodcock speaking at AAPS two years ago about how current batch production – which would not look out of place in the 1950s – will be obsolete in the next 25 years, shaking up the industry.
We asked Fazio if this was the case, to which he agreed, saying in his opinion “this is absolutely the start of the end [of batch manufacturing]. It’s something that many intelligent professionals have been thinking about for a while and it’s basically coming to fruition.”
‘The 20 Minuters’
GEA has two concepts in continuous manufacturing, one being modular wet granulation and the other being direct compression.
For wet granulation, the raw material is processed in bulk containers and fed into a segmented fluid bed dryer before entering a particle conditioning unit where it is sized. The material is then milled before being pneumatically transferred into an inline blender and then introduced immediately into a tablet press.
“This is all done in a continuous fashion,” Fazio said. “The time from the raw material addition until a finished tablet is about 20-5 minutes.”
As for competition, Fazio told us GEA is in the unique position of owning all the applicable solid-dosage process technologies and is developing the software to integrate all the pieces under one operating system.
“Our competitors do offer a continuous rig similar to us,” he said, though they are formed of individual companies with “a tablet press competitor, a blending competitor, a granulation competitor having joined forces.
“They make their equipment together, they mechanically integrate it, but the software integration, the ‘handshakes’ so that each piece of equipment is communicating to each other is something that they will struggle with, as they are 3 or 4 different companies.”
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