A new way to separate antibodies
So far the industry stood for the established purification procedures are available, although reliable but are not very flexible and development-intensive and thus expensive. Regarding scale, purity, or freedom from contamination should the procedure for the purification of pharmaceutical proteins are constantly adapted to the growing demands, says Kiefer. Other hand, are desirable in so-called downstream processing, process steps are carried out continuously to behave robust against variations in process parameters and use inexpensive materials that governmental regulation of the biopharmaceutical product manufacturing meet (Good Manufacturing Practice).
Within the BMBF-project will be explored in an interdisciplinary collaboration between biologists, biochemists, chemists and process engineers, as the technical protein crystallization can be considered as a novel separation process for biopharmaceuticals, particularly antibodies, are used. The process was scaled up so far that a transfer was to ensure production standards on the industry, says Kiefer.
Next would be sought with the physico-chemical methods of optimum conditions under which the protein can crystallize without loss of activity, describes Professor Pine's approach. It will initially rely on screening procedures, which are common in structural biology. Subsequently, detailed phase diagrams were created to allow a subsequent process control. The demands of the industry in this process were clearly defined from the outset by the pharmaceutical companies, achieved so that economic viability is ensured once the milestones are.
Within the BMBF-project will be explored in an interdisciplinary collaboration between biologists, biochemists, chemists and process engineers, as the technical protein crystallization can be considered as a novel separation process for biopharmaceuticals, particularly antibodies, are used. The process was scaled up so far that a transfer was to ensure production standards on the industry, says Kiefer.
Next would be sought with the physico-chemical methods of optimum conditions under which the protein can crystallize without loss of activity, describes Professor Pine's approach. It will initially rely on screening procedures, which are common in structural biology. Subsequently, detailed phase diagrams were created to allow a subsequent process control. The demands of the industry in this process were clearly defined from the outset by the pharmaceutical companies, achieved so that economic viability is ensured once the milestones are.
franzb - 5. Jan, 15:59
