The pharmaceutical industry has been dipping its toe into the water of continuous manufacturing for years. Richard Fazackerley, Technical Director, Finished Dose, Aesica Formulation Development (Nottingham, UK) asks the question: are we finally ready to dive in?
Many facilities across the world are still strongly wedded to a batch process philosophy. To be fair, it has served the industry well, especially as it suited current technology. Most of the operating principles for key equipment have not fundamentally changed since their original inception, despite additional features and PC controllers.
Historically, there has been reluctance to change the model: if increased capacity was required, you simply made more or larger batches. But this philosophy has led to a significant amount of work in progress and required forward cover in the supply chain to avoid the risk of stock out. Indeed, the industry been a laggard in moving away from familiar processes and technologies. An absence of economic drivers and perceived regulatory barriers has added to the disinterest in change. Moreover, many companies have such large estates of legacy technology that changing was seen as an extremely challenging task.
“Change is most definitely in the wind,” notes Richard. In recent years, pharma has seen a marked shift away from the old culture of risk aversion and is calling out for more efficient economic models. Gone are the days of “if it ain’t broke, don’t fix it.” We’re starting to see a move away from traditional attitudes and towards the new reality of continuous manufacturing.
The principles of continuous manufacturing have been around for decades, but it is only now that the technology has come of age that many larger companies are starting to adopt them. Many of the perceived external barriers have gone. There is a positive regulatory environment, with agencies supporting the adoption of this new disruptive technology. Plus, the technology itself has now reached a point where it is both available and commercially viable.
The global pressures of the 21st century will not relent. Quality and compliance will remain an important focus for all manufacturing industries, but performance will be the key to ongoing survival in light of ever-increasing cost pressures from payers. Maximizing efficiency is essential in today’s world as margins erode, R&D productivity struggles and payers challenge each new product introduction.
Personalized medicine will result in more targeted products, resulting in lower demand for individual drugs and undermining the current system of batch processing and supply chain practices across the industry. It’s clear that continuous manufacturing is much better positioned to meet today’s – and tomorrow’s – demands.
Another area where traditional batch processing falls down is the ability to develop new products as quickly and efficiently as possible, particularly in the earlier stages of development where there are potential constraints on API supply and a high risk of failure. Continuous manufacturing allows companies to develop and explore the process with minimal amounts of API using a combination of small-scale, advanced process control systems and integrated process analytical technology. In other words, you get as much information as possible for as small an API investment as possible, as quickly as possible.
With all of these benefits, it’s no wonder there is so much activity around continuous manufacturing from both pharmaceutical companies and equipment suppliers – and not just for development and manufacturing. Continuous manufacturing technology offers a way to fundamentally change supply chain models by moving away from a large fixed asset base to a more mobile capability where the factory can be moved to where the demand is.
Richard concludes: “We are on the cusp of a revolution. Are you ready?”