MAbs and Biotherapeutics Direct from the Bioreactor
July 1, 2008
Upfront Chromatography A/S is a Danish company with significant expertise in the development of customized industrial processes. Successful operation of industrial separations provides proven scalability for biopharmaceutical manufacturers. Upfront Chromatography’s Rhobust™ technology has been developed to maximize the effectiveness of capture adsorption steps, using second-generation expanded-bed technology.
Rhobust™ consists of
Mixed-mode ligand chemistry (robust adsorbents with added selectivity)
Tungsten carbide densified agarose that enables robust operation of expanded bed
Dedicated hardware designs (robust fluid distribution systems without meshes, frits, or porous plates).
A key advantage of the Rhobust™ platform is that it can be used directly with unclarified feedstocks. The chromatographic adsorbent captures protein molecules in one simple downstream process. Neither clarification nor adsorbent packing and repacking is required; it enables NaOH cleaning (at high temperatures) as well as enhanced selectivity upfront in the process.
Cost-Effective and Robust Processes with Rhobust™
For pilot plants and other multiproduct facilities, no presanitization, extensive prequalification testing, CIP, or cleaning validation are required. Rhobust™ Flex disposable adsorption units offer all the advantages of Upfront technology in a simple, disposable format for toxicity studies through to Phase III trials.
From left to right above: a 2-cm diameter laboratory disposable column for MAb capture; a Rhobust™ Flex operating system with a 10-cm diameter (4-L) disposable column; and the same system with a 30-cm diameter column (35 L). ()
Bioreactor contents can be loaded directly onto the Rhobust Flex unit. The captured monoclonal antibody is then washed and eluted as a purified, clarified solution. The column can be used to process a whole disposable bioreactor in one day. Then the column and associated tubing can be disposed of, ready for the next bioreactor the next day. Two ligand chemistries are available for MAbs: protein A and a mixed-mode capture adsorbent.
Not processing a MAb? Upfront Chromatography A/S is set up to supply custom adsorbents based on the Rhobust platform. Whether your requirement is for one liter at an early stage in development or 1,000s of liters in industrial manufacturing, Upfront can ensure you process is cost effective and robust. Upfront’s research, development and ISO9001-compliant manufacturing facility is in Copenhagen, Denmark.
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