There are several vital components of biologics manufacturing that require the use of pumps. In each of these steps there are technology opportunities to either improve or hinder operational efficacy, efficiency, and quality control. While one type of pump may work for one process, it may not be the optimal choice for every process and may negatively affect different areas uniquely. A single pump, capable of handling various factors, is the ideal choice for facility simplicity and cost optimization.
The general theme of these requirements fit into just a few categories:
- Flow: ideally, a pump should create low to no pulsation and be able to accommodate a variety of flow ranges with accuracy and control
- Pressure: pumps used for biologics manufacturing need to adapt to a range of pressures
- Product integrity: sensitive materials are easily damaged by pumps that generate shear, heat, or contribute contaminants to the product stream. This is not specific to any one process but is key to overall product integrity.
When looking at chromatography columns, the primary concern is often maintaining high, constant flow rates. These columns are typically glass, steel, or plastic tubes filled with substances through which the biologic flows to capture or purify the product. The filter media is often quite expensive, and the right pump is key to maintaining the balance required for optimal function.
Tangential flow filtration (TFF) also requires constant, controllable flow rates. This process functions by moving fluid alongside (tangentially, as the name implies) a filter media. TFF allows filtration to take place without the same fouling associated with normal-flow, or “dead-end” filtration by flowing across a membrane rather than through it. It also means that TFF can function continuously, even with relatively high solids load, if the flow remains steady.
Another type of separation, virus filtration, uses a membrane to filter out particles of a particular size. Because the membrane can become fouled with solids, it is critical that the pump used in this process can manage changes, especially increases, in pressure. As with chromatography columns and TFF, virus filtration depends on reliable, controlled flow rates.
A relatively new aspect of biologics production, inline blending, is another place where pump performance can impact manufacturing processes. Liquid ingredients, blended by simple combination within a single manifold, are mixed as they are transferred. This is also known as inline mixing or continuous blending and is becoming the new best practice for rapid, continuous production facilities. Because the components are combined in line, this process requires excellent flow control in the blend manifold and in the metering of products entering the stream.
Lobe pumps and peristaltic pumps, often used in pharmaceutical and biologics manufacturing, prove problematic when their limitations are compared to the requirements presented by the processes above. The risks include slip, shear, heat addition, contamination via mechanical seals, degraded pump material and flow issues associated with solids handling or process restarts with lobe pumps. While peristaltic pump technology has improved, they still cause pulsing flow and have limited flow capacity and flow control. There’s also a risk of peristaltic pump tubing dissolving and affecting product purity, though these risks can sometimes be mitigated with proper tube material selection for each application.
Another pump type that sees wide adoption for all biologics processes is the quaternary diaphragm pump by Quattroflow. First invented in the late 1980s, the quaternary diaphragm pump was designed to address the specific issues associated with chromatography and TFF. Inspired by the human heart, these pumps gently move fluid through four chambers using subtle rotation and positive displacement. They have excellent, steady, controlled flow and are adaptable to different pressure ranges without creating shear or adding heat. Although they are suited for lower viscosity products (under 1,000 centipoise) with particles smaller than 0.1 mm in diameter, quaternary diaphragm pumps are highly versatile. They can be used in a variety of biologic applications.
When choosing pumps for biologics, all these processes and concerns must be considered. The right pump will save money upfront, reduce maintenance costs, and minimize product damage during manufacturing.
Learn more about how Liquidyne Process Technologies and Quattroflow Pumps can help support your biologics manufacturing by contacting us today!