3 | Is this the right time to consider full or partial continuous manufacturing?
This question isn’t a new one. Even before this pandemic, many OSD manufacturers had begun to adopt continuous manufacturing (CM), either as a full replacement for traditional batch operations or as part of a hybrid batch/CM system. Even the FDA, seeing the improved quality made possible by CM, has thrown its support behind this shift.
The incentives that first drew OSD manufacturers to CM are even more attractive as we face off against COVID-19. CM allows for denser use of a facility’s footprint. That means manufacturers can do more with less space, creating a virtuous cycle of efficiency and cost savings. More importantly, CM allows OSD manufacturers to vary their output quickly, without having to adjust equipment or sacrifice important cost efficiencies. This readies them for future spikes in demand, like the one we’re witnessing today while improving overall drug quality and consistency.
As a result of these advantages, we’re seeing many success stories involving continuous OSD manufacturing for other indications, and there’s no reason to believe the same won’t be true for a COVID-19 product.
Shifting to CM is a complex process. Multiple unit operations, traditionally partitioned inside individual suites, need to be transitioned into a fully or partially integrated production line along with certain standalone sub-processes. Solve this complexity by consultating with experts who understand pharmaceutical process design and who can advise on the best way forward.
A fully integrated CM platform
From “powders in” to “tablets out,” a fully integrated CM platform offers significant technical processing advantages and business benefits. It’s more complex to implement but encompasses the widest range of manufacturing capabilities.
A partially integrated or batch/continuous hybrid platform
Partial or hybrid CM systems typically start at powder feed and end at tablet compression, leaving other unit operations to the domain of traditional batch processing. OSD manufacturers who are eager to net some of the benefits of CM but who need faster, more immediate implementation might choose this route in the short-term, with plans to develop a more robust end-to-end CM platform in the future.