What do you think are the main factors that explain the current focus on continuous manufacturing?
This prevailing environment has brought the efficiency of manufacture under much scrutiny. Similarly, the regulatory focus on reducing risk has prompted questions about how well understood manufacturing processes are and how best to secure product quality. Within this context, a shift away from batch operation to continuous processing is seen as increasingly attractive.Continuous processing is an intrinsically more efficient approach, with a number of benefits:
That said, batch processing has some advantages too; an important point being that it simplifies the containment and isolation of an operating problem (an essential aspect of product recall). It is likely that some processes may always remain in batch mode rather than transitioning to continuous. This is exemplified by the chemical sector, which continues to successfully apply both strategies.
The scale up process for continuous processing is very different when compared with batch, could you explain some of the advantages?
One major advantage of continuous processing is that scaling up from lab to commercial-scale quantities is usually achieved by simply running the process for a greater length of time. While this may involve the addition of upgraded ancillary equipment, it essentially avoids the complications associated with changes in equipment geometry and size, which can be considerable. Meeting commercial production targets by operating a smaller unit continuously may, therefore, be much more straightforward than the alternative of persisting with batch production and scaling up by a considerable amount.
However, the aspiration of the industry is not just to switch from batch to continuous operation, but, perhaps more importantly, to extend processing knowledge, and to learn how to engineer and precisely control a manufacturing plant so as to achieve the very highest levels of efficiency and quality. This demands an in-depth understanding of those variables that define clinical performance and how to control them—the approach enshrined in quality by design.