Industry professionals at a continuous manufacturing (CM) summit last month said while the approach offers advantages, implementing the method can be challenging.
At the ‘Oral Solid Dosage (OSD) Continuous Manufacturing in the Current Regulatory Landscape’ summit, Janssen Pharmaceutical’s Lawrence de Belder said companies adopting current manufacturing (CM) must be prepared for change.
According to de Belder, the organisational changes that accompany CM business drivers can be challenging to implement, and trust must be built in order to maintain the vision, and consequently realise the benefits.
On returning from the summit, Rutgers University-based Centre for Structured Organic Particulate Systems’ (C-SOPS) Douglas Hausner said integrating CM requires coordination and communication for pharmaceutical companies.
“The integrated nature of CM processes coming from the coupling of traditionally separate unit operations also requires greater structural integration (coordination and communication) and management support.”
“CM effort is front loaded, and while process understanding and associated robustness have significant benefits, shifting the costs and effort within the organisation can be challenging,” he added.
CM advantages
According to Hausner, the advantages of CM vary.
“Some companies may get a huge advantage just looking at how the lack of work-in-progress material can affect capital, and in generics, some are looking at continuous manufacturing as a way of separating themselves from competitors from a quality standpoint,” he said.
“I personally believe the biggest advantage is in speed of process development and the tremendous amount of information and process understanding that can be generated.”
Academics, industry groups and EU health ministry representatives at the summit also discussed EU and US guidelines, and the importance of regulatory flexibility.
Hausner told in-PharmaTechnologist the first wave of adopters are being approved in the US and other markets, which he expects will trigger the next wave of CM adoption.