The increased adaption of monoclonal antibody based therapeutics has led to the common use of platform purification schemes. This approach has limitations with respect to prohibitively high cost of Protein A chromatographic media and molecular variations which may require custom polishing steps post Protein A capture. The need of the hour is to move beyond incremental advancements in biologics manufacturing in order to provide sustainable manufacturing solutions. The rise of single-use and disposable technologies is further pushing the envelope for downstream processing. Precipitation, of impurities or target antibody, provides a promising and cost-efficient alternative that can be incorporated as a feasible unit operation into the purification scheme. However, success of these processes will be dependent on minimization of variability across a wide range of biomolecules. Towards this goal, we evaluate performance of impurity precipitation coupled with non-chromatographic hydrogel based capture as part of downstream purification platform to provide an alternative to traditional column chromatography.  An array of clarified harvests were tested to ascertain process parameters and compared to traditional chromatographic purification. HCP-, aggregate-, fragment-, DNA-clearance and economic considerations will be evaluated to determine suitability of these processes, as either capture or polishing steps, in a platform based approach.<br/>

Evaluation of precipitation driven processes for monoclonal antibody downstream processing

249th National Meeting (2015)

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