BIOT 470 |
| Reduction of R&D cost associated with the introduction of new drugs to the market should lead to less expensive bio-molecule based therapies. For a constant probability of success, this cost can be reduced if a larger number of drug candidates are considered in a given time, which puts higher demands on process development work. Introduction of high throughput techniques for process development are thus very important for improving the overall economy of drug manufacturing. Currently, process development related to downstream processing is performed using packed bed chromatography. Typical parameters studied include determination of dynamic binding capacity (DBC), efficient wash and elution protocols. These studies are both time and resources consuming. Therefore, faster and scaled-down methods that could significantly reduce time necessary for developing a chromatography step are needed. This presentation will describe an alternative approach to column based investigations for generating DBC versus residence time data. The approach is based on collecting necessary data using microtiter filter plates filled with chromatographic resin and using the information obtained to predict dynamic binding capacities at various residence times. The proposed approach is less time consuming and requires significantly smaller sample size compared to traditional column based investigation. Analysis and evaluation of the proposed experimental method will be presented. Optimal conditions for different adsorption system will be discussed and recommendations will be given. Experimental results obtained with a model adsorption system consisting of MabSelect SuRe™ and hIgG, as well as obtained with a real feed containing monoclonal antibody will be presented. Experimental approaches for screening of load, wash and elution conditions will also be presented. The data obtained using the high throughput format will be compared with results obtained using the traditional column based approach. |
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Downstream Processing: High Throughput Screening in Process Development
2:00 PM-4:20 PM, Thursday, August 23, 2007 BCEC -- 107B, Oral
Division of Biochemical Technology |