Despite the promise of continuous manufacturing batch is still dominant. However, in the next quarter of a century the US Food and Drug Administration (FDA) expects gradual evolution to turn into revolution.
“Right now manufacturing experts from the 1950s would easily recognise processes today. In 25 years these same processes will be obsolete”, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the FDA, said in an AAPS 2011 keynote.
Adoption of continuous manufacturing will cause this change. Woodcock said the shift away from batch will “really change how things are done” and make production less polluting, more flexible and local.
Emerging markets emerge
Woodcock expects the rise of continuous manufacturing to occur in parallel to emerging markets establishing themselves in the industry. As emerging markets move from the periphery to become central to the industry Woodcock predicts the approach to harmonisation will change.
The main consequence will be emerging markets joining Japan, the US and Europe in setting global standards, Woodcock said. If this fails to occur industry and regulators will be burdened.
Having inspections by multiple regulators with slightly different attitudes and policies is inefficient. “This is a cost I don’t think the system will be able to bear in the future”, Woodcock said.
The alternative is having uniform regulatory expectations around the world. By setting such standards and adopting quality-by-design (QbD) Woodcock thinks regulatory oversight can be cut.
“We can influence this part of the future”, Woodcock said.