Academics, industry groups and EU health ministry representatives met at the ‘Oral Solid Dosage (OSD) Continuous Manufacturing in the Current Regulatory Landscape’ summit in Malta to discuss continuous solid dose manufacturing regulations.
Rutgers University-based Centre for Structured Organic Particulate Systems’ (C-SOPS) Douglas Hausner said whereas the US Food and Drug Administration is supporting the implementation of continuous manufacturing (CM) technology, European regulators are behind in offering industry guidelines.
“Currently the FDA is strongly advocating for the adoption of the technology. They have created specific offices to facilitate this technology, funded work at universities, re-aligned internally, and hired a significant number of engineers all within the last 2-3 years,” Hausner told Biopharma-Reporter.
“In my opinion, they really could not be encouraging this more than they are already are,” he said.
In the EU, however, Hausner has observed an ‘open-arms’ approach to CM from industry, but a lack of specific guidance from regulators.
“People are very eager for regulatory clarity and guidance on this topic, but the regulators are not yet ready to put that out there,” said Hausner.
He added, “EMA [European Medicines Agency] isn’t set up like the FDA, it doesn’t have the same centralised lab facilities, funding or direct personnel. As a result, EMA is looking to learn from applications,” he told us.
Regulatory flexibility
Industry representatives at the International Institute for Advanced Pharmaceutical Manufacturing (I2APM) and C-SOPS-run event agreed that regulatory flexibility is crucial to the adoption of CM technologies.
At the conference, Janssen Pharmaceutical’s Lawrence de Belder said regulatory flexibility towards small formulation changes will be imperative to flexible supply chains using CM.
Merck’s executive director for its chemistry, manufacturing and control (CMC) Policy and former FDA employee Christine Moore said, with regards to regulations, the “the biggest challenge we have is alignments,” which she says is slowing the rate of adoption.
She explained that the highest risk is alignment on control strategies, and the ability to use multiple formulations during the transition over the next decade, when both batch and continuous processes may need to be maintained for the same product.