Single-Use Pumps Meet Biopharmaceutical Industry Challenges
The Biopharmaceutical Boom
Increased emphasis on biologics significant for pump industry
Biopharmaceuticals represent a multi-billion-dollar industry with huge potential for future growth. The recent interest in advanced biologically derived drugs (known as biologics) for the treatment of diseases offers immense opportunity for the industrial manufacturers who supply the technology needed to test and produce biologics. Biologics differ from traditional pharmaceutical drugs because they are created through biologically induced processes, which require specific equipment to accurately produce.
Development requirements combine quality and speed to market
The development and commercialization of biologically derived drugs are constrained by two main factors. One, they must be produced and tested in highly controlled, sterile environments with adherence to strict operational parameters such as the correct pH level, temperature, oxygen level and nutrient feed. The use of equipment that does not meet these requirements can be detrimental to the quality of the drugs produced. Two, they must be produced as efficiently as possible to commercialize with as much time left on the patent as possible. Patent submission must occur during the drug development process but before the drug is FDA approved and ready to be put on the shelves. By the time a drug goes to market, it could have as little as seven years left on its patent. Every patented year can be worth billions of dollars in sales, so speed to market for these drugs can significantly impact company revenue.
The harvesting and purification of biologic target materials is accomplished using separation and filtering processes. There are generally three purification processes (that can also be used in combination). These include Tangential Flow Filtration, Chromatography Columns, and Centrifuges. Biologics are sensitive to any change in pumping, because it could cause harm to the media being pumped or costly damage to the pump parts.
The best pump option for these processes must operate with the following capabilities:
- High purity and sterility
- Very low volume and surface area exposure; 15 ml/73.5 cm2 in the smallest pump
- Low levels of leachables and extractibles
- No mechanical spalling/shedding of contact materials
- Controlled/constant flow and pressure
- Low shear, slip, and pulsation
- Self-priming and negative suction lift
- High volumetric efficiency
- No heat addition
The Right Pump for the Job
Single-use positive displacement quaternary diaphragm pumps
Though several pumping technologies have been used in the the development of biologics, all have failed to accurately meet all the criteria required for quality and speed to market except for one. Single-use positive displacement quaternary diaphragm pumps are the best option for applications in the biopharmaceutical industry, addressing the specific requirements inherent in the development of biologics.
Permanent stainless-steel process lines are expensive to install and have complex and time-consuming cleaning and validation requirements. Several pump types do not offer single-use options, making them less suited for handling biologics. Other pump types feature mechanical seals, which jeopardize the sterility of the transported media or can not maintain the constant pressure/flow necessary to transport biologics without damaging them.
Single-use pumps can consist of bags instead of stainless-steel vessels, special agitators instead of stainless-steel shaft agitators, single-use tubing, coupling and valves instead of their stainless-steel equivalents, and filter systems, many of which are single- use by their very nature. This enables biopharmaceutical manufacturers to optimize the cost of cleaning and validating their pumps. The result is not only a quicker production process, but one that delivers preferred levels of product purity and sterility with no chance for cross-batch or cross-product contamination. Often, single-use systems are much less expensive than permanent stainless steel systems because they do not carry the cost of validation or installation.
The right pump is needed to optimize development and manufacturing processes for biologic products, both in regards to speed-to-market considerations and contaminant-free production requirements. Single-use quaternary diaphragm pumps offer that optimization.
Quattroflow, a member of Pump Solutions Group (PSG), offers its single-use quaternary diaphragm pump for use in critical product-handling applications in the pharmaceutical and biotech industries. The pump is uniquely modeled after the human heart; the quaternary diaphragms are driven one after another by a connector plate, which moves back and forth out of its central position in a stroke that is generated by an eccentric shaft, with the length of the stroke determined by the angle of the eccentricity. This design meets all the criteria of transporting biologics, including run-dry and self-priming capabilities, no operational heat buildup, low shear, low pulsation, and leak free operation. The pumps can provide constant flow from 1 L/hr (0.0047 gpm) to 20,000 L/hr (88 gpm) with some of the highest turn up/down capabilities in the industry.
Read the full article on the PSG Dover website.