In Pharma 4.0, drug manufacturers will use digital features in many products to gain a deeper understanding of the processes involved in making new medicines. The basis of this transition involves more knowledge of processes across the life cycle of a drug, and using that information to increase the speed and raise the efficacy of the drug-making industry. Reaching Pharma 4.0 will require improvements in most, if not all, processes and devices used in drug R&D and manufacturing. Various products in filtration will play a role in this pharmaceutical transition.
In a biopharma lab, scientists frequently use peristaltic pumps and tubing in filtration steps. “Peristaltic pumps are perfect for sensitive filtration applications such as in biopharma due to their low shear and low maintenance that comes with single-use tubing,” says Phil Nyren, global product manager at Masterflex. Today’s pumps can even provide communication options from standard analog control options to automation protocols including Ethernet/IP or a well-known automation standard like PROFIBUS. In some pumps, the communication options allow easy firmware updates. This capability eliminates the need to send the equipment back to the manufacturer for new firmware, making pump maintenance easier for technicians.
As the pharmaceutical industry evolves to Pharma 4.0, manufacturers will collect increasing amounts of data about product safety, such as potential sources of contamination. For example, biopharmaceutical pump tubing must be formulated to keep extractable and leachable contamination to low levels in the samples or products. Plus, too much contamination from the tubing reduces the efficiency of downstream filters.
Biopharma industry evolution
Across biopharma, companies look for ways to automate more processes with the key goal of improving efficiency. Modern filtration equipment allows more opportunities for automation. In particular, sensors incorporated in filtration processes provide data that can be used to control the pump. “Until now, this functionality required significant in-house resources to implement and maintain at full scale,” explains Michael Knapp, global product manager at Masterflex.
In some modern filtration systems, for example, an ultrasonic sensor collects flow data and a controller uses that information to adjust the speed of a peristaltic pump. This technology automatically provides the desired downstream flow throughout the filter and tubing—all with no manual adjustments.
As the industry increases its flexibility by replacing many of the traditional stainless steel bioreactors with single-use bags, the filtration processes must adjust accordingly. So, things like single-use sensors will be incorporated in single-use filtration systems. According to Knapp, single-use sensors also “provide improved material traceability and ease of integration into existing hygienic processes.”
As health care incorporates more personalized medicines, biopharma manufacturers will work in smaller batches, like some of the ones designed for single-use applications. Plus, ongoing advances in pharmaceuticals mandate the ability to quickly change the product on a line. Here again, single-use technology simplifies such product-manufacturing changes. The filtration systems must continue to advance to accommodate such changes in the production process. That is, biopharma filtration devices must be single-use, too, where needed.
In addition to flexibility, single-use technology—for filtration and more—can reduce the overhead for entering the industry. Such economic benefits can allow smaller companies to compete with larger ones or help biopharma manufacturing reach more isolated areas. As a result, advances in biopharma filtration will play a crucial role for the industry, and allow more companies to enter the market.