Monoclonal antibodies are one of the most exciting developments in medicine of recent years. Unlike traditional disease treatments, these are developed specifically to attack individual cells. Some monoclonal treatments are already available for select types of cancers. Others are used for immune system suppression, improving quality-of-life for arthritis sufferers, and recipients of organ donation.
Biopharmaceutical manufacturing and manufacturing equipment
Production of monoclonal antibodies is a complex process. It begins with a kind of fermentation followed by extensive purification via chromatography-type processes to remove every trace of contaminant. Only then can the drug be packaged for delivery.
Throughout manufacturing cleanliness is absolutely essential. The slightest trace of contamination could jeopardize patient health. To eliminate such risk the liquids and gases employed should all be of ultra high purity (UHP) grade. (A UHP gas will be more than 99.9995% pure.) Maintaining such cleanliness is a constant struggle for biopharmaceutical manufacturers. Contact surfaces must be inert (precluding the use of some plastics) and should also be capable of being aseptically clean. That requires the use of materials able to withstand steam and/or caustic cleaning processes.
Design of biopharmaceutical processing equipment (BPE) is addressed in the ASME BPE standard. This covers practically every aspect of design and manufacturing including the materials used, and joining and finishing processes. Flow monitors and flow meters are essential components of modern BPE, so as with every other system component, these must be designed appropriately.
ChemTec products for UHP Liquids and Gases
Many of the processes used in production of monoclonal antibodies and other biopharmaceutical products depend on low flows of gases and liquids. Consistent production depends on maintaining stable conditions, and ChemTec flow monitors are designed for reliable and repeatable performance in such environments.
Two examples of UHP fluid handling components from ChemTec are the LPH and MAO product families. The LPH series is a fixed actuation flow monitor designed to detect low and high flow conditions. These suspend a magnetic piston in the flow and use an external sensor to detect a change in flow.
The MAO series is a line of flow meters that use the displacement of an internal piston to create an electrical signal proportional to flow rate.Voltage, pulse, and current loop outputs are provided.
Both LPH and MAO products are offered in 316 SS with electropolished RA finish and Teflon (more properly known as PTFE.) for use in Ultra High Purity applications.
316 stainless steel with electropolished RA finish resists corrosion and the smooth internal surfaces allows for contaminant free flow. This type of finish is crucial when the fluid contains particles that could become lodged in crevices. Teflon/PTFE also provides good high temperature resistance with the added benefit of being completely inert.
Use the right components
The development of monoclonal antibodies and other advanced biopharmaceuticals is bringing hope to many. The safe production of these advanced biopharmaceuticals demands the highest levels of cleanliness. This is assured by using UHP fluids which require UHP components in the fluid handling system.
ChemTec’s low flow monitoring Ultra High Purity products are designed for such conditions. For further information, contact a ChemTec product specialist.
