Disposable chromatography units launched for capture of monoclonal antibodies
Upfront Chromatography, a developer of customised industrial-scale separation services, has launched disposable adsorption units for capturing monoclonal antibodies.
The disposable units adsorb therapeutic proteins directly from the bioreactor without the need for cleaning, validation and clarification steps, such as filtration and centrifugation. This reduces the overall cost and environmental burden of manufacturing.
Monoclonal antibodies and antibody fragments continue to be a major discovery platform for therapeutic agents. Contract manufacturing organisations (CMOs) and pilot plant facilities are under pressure to maximise their throughput of pipeline therapeutics without compromising on purity, quality and product safety. Disposable downstream processing units offer greater flexibility for manufacturing and have been shown to improve productivity in generating clinical trial materials, says the company.
The integrated disposable chromatography system is based on the proprietary Rhobust universal processing platform. Rhobust has been implemented in a range of industrial settings for commercial-scale recovery and purification of functional biomolecules, including monoclonal antibodies, direct from crude feedstocks. A key feature of Rhobust is that it does not generate pressure during operation, thereby enabling construction of cost-effective, disposable columns from plastic.
The combined advantages of disposability and crude feedstock processing have delivered a single high-yielding system which eliminates the requirement for pre-clarification of the feedstock, says the company.
Allan Lihme, cto and founder of Upfront Chromatography, said that three processing operations have been combined into just one disposable unit and because these systems do not generate any back-pressure, disposable tubing can be safely used in the pumping system rather than stainless steel piping that requires validated cleaning.
The Rhobust Flex disposable units are operated by a flexible pumping and data acquisition system, that itself requires minimal cleaning and uses disposable tubing to minimise cross contamination of clinical trial products. Clearance of cells and cellular debris is as complete as performing two clarification processes and a traditional packed bed adsorption procedure.