Continuous Manufacturing in Life Sciences
Pharmaceutical companies are regularly seen as leaders in adopting high technology solutions, especially in support of their extensive R&D ambitions. However, when it comes to the actual manufacturing of commercial products, especially in tablet form, the picture is usually anything but cutting edge. Tablets are still manufactured in batches, with bins moving bulk product from room to room, until they are finally compressed into tablets, coated and then moved to packaging.
Not surprisingly, this mode of batch manufacturing is more error prone and expensive than so-called continuous manufacturing. Yet continuous manufacturing is nothing new. For decades, it has been serving other process industries very well. Even modern cookie manufacturing, not dissimilar in some ways to manufacturing of tablets, is usually a continuous process.
There are some good reasons for traditional pharmaceutical manufacturing to have been left more-or-less unchanged for decades, revolving around healthy profit margins and low COGS (Cost of Goods Sold). But times are changing, and several interesting initiatives are underway to shine a light on pharmaceutical manufacturing.
A new approach
One initiative that appears to be in the vanguard is the “Engineering Research Center for Structured Organic Particulate Systems” or C-SOPS. C-SOPS has participation from a number of universities including Rutgers and Purdue, as well as from numerous pharmaceutical manufacturers. Importantly, it also enjoys support from the National Sciences Foundation and from the Food and Drug Administration. At its disposal, it has full-scale continuous manufacturing plants at multiple sites, all in an effort to develop novel continuous manufacturing processes. Continuous manufacturing has many advantages for pharmaceutical product including flexible batch sizes, better quality control, smaller equipment and faster development.
Not only are the C-SOPS facilities capable of modeling production processes for tablets, but they can evaluate drug delivery via strip film technology, which is inherently more amenable to continuous processes.
With the participation of the FDA, the all-important view of the regulatory impact on core topics such as validated batch size can be examined. But as with any new approach, the proof of the pudding is in the eating. C-SOPS has already reported regulatory approval for the first ever product to have been manufactured in a continuous process, with others already in the pipeline.
It is indeed a propitious time for engineers and scientists who are involved in pharmaceutical manufacturing; slowly but surely it seems that the old way of doing things may finally be complemented by a more efficient, flexible and cost-effective approach.
Hello Stephen ,
Really good blog .
For Pharma & Life science ,incoming quality inspection ,product quality has been most important process in manufactruing,with continuous manufacturing ,undertaking quality inspection for a batch has been a challenge .Also FDA has not regulated any standards for smart batches ,what FDA regulates for usage of electronic system is monitoring and audit logs of every activity .
I see Data Integrity ,Centralized Systems and Product Quality for batches as major blockers .May be with the new researches the answers can be found to this .
Thank You ,