Peristaltic Pumps Meet the Demands of Biopharma Processes
By Eric Rentsch, Masterflex Product Marketing Manager, Cole-Parmer
The biopharmaceutical industry has grown consistently as new therapies are developed to treat diseases across the globe. This trend requires scale-up production methods for various medications that maintain quality along with agile bioprocess systems that meet the shifting demands of a diversified market.
The increasing demands for scalability and sterility of biopharmaceuticals have led to the integration of truly aseptic options that use peristaltic pump technology.
The Benefits of Peristaltic Pumps
Major steps in biopharmaceutical production include media preparation, fermentation, harvesting, purification, and fill or finish. Other metering pump technologies are being replaced by peristaltic pumps, which can provide more flexible and reliable fluid handling.
Biopharmaceuticals are fermented in bioreactors from biological materials rather than chemically-synthesized molecules. Although these types of medications may offer more effective and specific drug delivery for patients, they are also more sensitive to contamination and the effects of mechanical shear. Here, peristaltic pumps excel. Peristaltic pumps alternately compress and release flexible tubing that contains the fluids. As a roller passes over, the tubing is first occluded (squeezed) and then released.
To grow biologics inside bioreactors, specific conditions must be maintained and media must be injected and recirculated. Peristaltic pumps also work well here — they can move fixed amounts of fluid per motor revolution to produce precise and reproducible dosing. The titer of the product (called target biologic density) increases over time, making it more likely that cells will rupture during recirculation. The gentle squeezing action of peristaltic pumps creates less shear than other pump types.
During harvest and purification, mitigating the risk of cross-contamination is crucial. Peristaltic pumps are ideal here because their flexible tubing can be quickly replaced rather than sterilized, so there are no cleaning methods to validate. And, because the fluid only comes into contact with the tubing, material validation is limited. Most manufacturers will also offer validation packets to verify that their components are safe for biologic production.
The final step is fill/finish. This can take weeks of labor and costly materials. As the product moves downstream, fill/finish is where the product is most valuable and at risk. Peristaltic pumps show their real value at this stage. They can accept various tube sizes, allowing process scalability.
Peristaltic Pump Tubing
Some pump tubing is formulated specifically for cell transfer applications. Formulations like Masterflex Puri-Flex and silicone feature smooth inner surfaces for low protein binding and low leachables and extractables. This maximizes bioreactor cell vitality throughout the growth cycle to produce a higher titer.
It is important to note that peristaltic pump tubing is separate and distinct from tubing for general fluid transfer. Peristaltic pump tubing undergoes significant pressure that could cause spallation or premature rupture of other tubing. Materials from the lining of the inner tubing can also flake off due to wear, which can affect the integrity of the product and change the volume of fluid being delivered each revolution, ultimately affecting pump precision.
When choosing pump tubing, make sure that proper testing was performed with the manufacturer’s own peristaltic pump models because each has different magnitudes of mechanical stress. Masterflex tubing is tested with Masterflex pumps to ensure accuracy and meet specifications.
Peristaltic pumps are driving more efficient fluid handling due to their ability to meet the challenges of scalability and sterility demands in biopharmaceutical processing today.
