Technology innovation often causes a domino effect, regardless of which industry is experiencing process improvement and change. Updates in one area highlight the flaws in other aspects, pushing engineers to develop new solutions to old problems. Biopharmaceutical manufacturing is no exception to this rule. With advances in automation, single-use equipment, and an increased expectation for flexibility, process engineers have begun to examine the wisdom of traditional batch manufacturing.
In the past, batch manufacturing has been the gold standard for the pharmaceutical industry. Despite the rapid adoption of continuous manufacturing in other sectors, biopharma has stubbornly clung to a batch mentality. Often, what this means for the production process, is that biologics and other products are created in a stepwise manner. Once one step, or batch, is completed, the next starts. This can cause a bottleneck and corresponding delay in the time it takes to produce biologics from start to finish. Sometimes these delays are short (hours), but sometimes these delays take days or even weeks, potentially harming product integrity.
Estimates indicate that this manufacturing technique could be costing the pharmaceutical industry around $50 billion each year. In the current economic climate, this number is staggering and demands serious attention. But what alternatives do pharmaceutical manufacturing companies have? And what challenges face manufacturers who move away from batching?
Continuous manufacturing is the growing trend that is on pace to replace batching. As the name implies, this technique requires constant momentum, moving biologics, and ingredients directly from one step of manufacturing to the next. When continuous manufacturing is done well, no hold or wait time, and operations run 24/7 to produce products. It begins with raw materials and stops only when the endpoint of the process is reached. Because of this, there is rarely a need to shut down equipment, reducing time to completion, costs, and improving quality control. Continuous manufacturing promises drug production in as little as a day, compared to the exaggerated timeline associated with batch manufacturing.
Implementing and utilizing continuous manufacturing is not without challenges, however. There are broad industry concerns regarding the material robustness of parts in terms of equipment, especially replaceable elements (like pump hoses) over time. With the shift to single-use technology, this issue is at the forefront for some manufacturers because single-use equipment largely relies on these replaceable parts to function. Additionally, continuous manufacturing requires facilities to step up operations in almost every way. Continuous manufacturing necessitates more sensors with high accuracy, integration of equipment with these sensors to enable automation, and a more robust supply chain to handle the constant demand associated with consistent manufacturing efforts. Many technologies are being developed to meet these needs but may require more work before they are robust enough to displace their batch counterparts. These issues add up to a potentially large price tag associated with going batch-less.
Another issue worth considering is the difficulty in tracking product integrity in a continuous manufacturing system. With batches, it’s easy to track down the step where a product was compromised and issue a recall, if necessary, based on that step. Without batches, recalls rely heavily on sensors and automation to identify contamination.
The FDA and many manufacturers believe that technology is at a place to overcome these challenges, however. And with good reason – the advantages of continuous manufacturing are substantial when done correctly.
Some estimates suggest that continuous manufacturing could reduce workforce, product deviation, and manufacturing footprint by greater than fifty percent. Continuous manufacturing facilities also use around forty percent less power and have a quicker setup and scale-up time frame. Overall, switching to continuous processes may improve efficiency, manufacturing robustness, and enhance quality control while reducing waste and cost inputs. These systems are also more flexible, becoming a vital feature of the market’s most competitive manufacturing facilities.
To capture these advantages, choosing the right equipment is essential. Pumps, for example, vary in reliability over time depending on type and hose quality. Peristaltic pumps tend to experience rapid hose wear, but advances in hose material reduce some of these concerns, as with the GORE® STA-PURE® Pump Tubing, Series PCS. This tubing shows reduced failures even after 90 days of continuous operation. Quaternary diaphragm pumps by Quattroflow eliminate the concern around tube wear entirely by introducing a gentle, pulsing flow enabled by differential pressure in each of the chambers rather than active mechanical forcing of product through the pump.
Single-use technologies may also be better suited for continuous manufacturing processes in general, as their longevity is equal to the task. These equipment types reduce downtime between production runs, which is critical in maintaining flexibility if a facility anticipates sequential continuous manufacturing of more than one product type.
Like Liquidyne, who can help to choose the equipment best suited for specific production needs, identifying a distributor is important when considering a switch from batch manufacturing to continuous.
Learn more about how Liquidyne Process Technologies can help support your process manufacturing needs by contacting us today!