For a number of years the buzz around continuous manufacturing as the next big leap in pharmaceutical manufacturing has grown. From companies looking for greater efficiency in their processes to governmental regulations enacting changes, the tableting industry has been working hard on solving this puzzle. While the theories of how a company can enact these changes seam relatively simple, the real-world complex nature of solid dosage tablets leaves numerous pieces still on the table.
In 2011, Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA) stated, “Right now, manufacturing experts from the 1950s would easily recognize the pharmaceutical manufacturing processes of today. It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing.” Today, many experts believe we are on the cusp of enacting these changes, with many industry experts agreeing the changes could be within the next decade.
Who is driving the changes in continuous manufacturing?
With the gentle but not-so-subtle encouragement from the FDA, companies are taking initiatives to move the industry into the future. And with major players in the field—GlaxoSmithKline, Amgen, Vertex Pharmaceuticals—making significant capital commitments in the hundreds of millions of dollars for everything from new facilities to line additions, these numbers say much about the sense of urgency.
We also shouldn’t leave out the aforementioned issue stated by Dr. Woodcock regarding time: companies have been operating in a batch process structure for decades with billions of dollars spent on creating their current systems. A soon to be antiquated system? All of this coupled with a typical corporate hesitancy for change, and you can see why the pharmaceutical industry is a bit of a laggard when compared to other manufacturing industries.
Why the change now?
There are a number of reasons and entities responsible for the interest in moving into continuous manufacturing, the biggest being cost. For the manufacturer, generating tablets in larger quantities should provide a lower-per-tablet cost. The hope of many related to the industry, from insurance companies to the end users, is that these lower-per-tablet costs will result in a lower cost for the end user. This in turn could ease cost pressures without the pharmaceutical companies forced to reduce their profit margins.
So why are the changes so difficult to enact?
There are a number of processes within the manufacturing of tablets that must be taken into consideration. From raw materials, which continue to be batch created, to the regulations requiring proper and regular cleaning, each minor issue compounds to create greater problems. As continuous manufacturing gains momentum, each of these areas will need to be addressed from start to finish, with the entire process in mind.
Quality control measures are also front-of-mind. The beauty of the current batch process is that manufacturers are able to detect, analyze and correct problems without generating large amounts of waste. When moving into the continuous model, manufacturers will need to ensure that quality of end products are not compromised with necessary changes. Instead of checking at the ends of smaller batches, companies may need to implement in-process sampling to keep quality standards high.
Where will it go from here?
We’ve only barely touched on this massive subject, and truly only time will tell. With the current interest and pressure to create these systems, it is certain that continuous manufacturing is here to stay. But the end result may look much different than current perceptions. With modifications needed from raw material suppliers to innovations in manufacturing equipment, these changes will require multiple pieces of the puzzle falling into place to solve numerous issues.
Rest assured, innovation within the tablet compression industry is at the very heart of Natoli Engineering, and as the demands of the industry modify and evolve, Natoli is committed to creating better solutions for tomorrow.