Parsippany (USA), 28 June 2011 -- Royal DSM, the global Life Sciences and Materials Sciences company, today announced the introduction of the Kremer Method™, an innovative proprietary technology developed by DSM scientists which improves downstream processing of monoclonal antibodies (mAbs) for faster and more cost effective production of biopharmaceuticals. The Kremer Method™ reduces processing and preparation times, labor and materials requirements and cost of goods for a more sustainable manufacturing platform.
DSM provides and develops technologies for optimizing mammalian cell culture processes. Examples are the proprietary XD® Technology for use with mammalian cell lines. The XD® process creates very high cell densities within the bioreactor, resulting in significant output enhancements of 5-15 fold using commercially available equipment. In the downstream processing area, DSM’s proprietary Rhobust® technology is the next generation in expanded bed chromatography (EBA), using cross linked agarose beads with Tungsten Carbide to increase the particle density. Rhobust® is applied as a direct capture and clarification step for mammalian and microbial harvest to increase yields, reduce the number of unit operations and reduce process cost. The new Kremer Method™ further optimizes the downstream processing of proteins and monoclonal antibodies.
Karen King, President of DSM Biologics, a business unit of DSM Pharmaceutical Products, commented: “DSM is continually innovating to advance the world of biopharmaceutical manufacturing to the next level. We are pleased to announce the introduction of the new DSP optimization technology, the Kremer Method™. The combination of the Kremer Method™ with our other proprietary technologies significantly reduces the overall costs and processing times of biopharmaceuticals while maintaining high product quality.”
Rolf Douwenga, Vice President of Global R&D for DSM Biologics explained: “The Kremer Method™ is a valuable addition to the platform of DSM’s technologies addressing the full range of mammalian cell culture systems for protein and monoclonal antibody production. The method uses in-line dilution to streamline the purification and polishing of mAbs into one single continuous step in a flow-through mode. This eliminates the need for storage and reduces the amount of material usage such as buffers and resins. The Kremer Method™ reduces processing and preparation times, labor requirements and the cost of goods and presents an ideal solution to achieving cost effective processing.”
After the capture step in conventional downstream processes, further purification and polishing of proteins are traditionally carried out as two separate batch unit operations. With the Kremer Method™ these steps are streamlined to work as one single unit operation. Using this method; Host Cell Proteins (HCP’s) were removed to a level below the limits of detection; complete aggregate removal was observed comparable to current state of the art processes; and recoveries of 90% were achieved. Several patent applications have already been filed.
XD® is a registered trademark of DSM
Rhobust® is a registered trademark of DSM
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