Wednesday, 16 May 2007
3rd Floor Hall (Pfahler Hall)
172

Implementation of a pre-filter prior to a chromatography processing step in a monoclonal antibody manufacturing process

Joann Bannon, Michele Myers, Peter Wojceichowski, Leslie Feggans-Haynes, and Camille Keating. Global Biologics Supply Chain, LLC, Malvern, PA

During the manufacture of a monoclonal antibody, product was observed in the column effluent during the load phase of one of the chromatography processing steps. Precipitate observed in the feed stream was thought to contribute to the abnormal flow dynamics within the column, thereby causing the breakthrough observed. The addition of a depth filter and a polishing filter prior to the chromatography step for the removal of the precipitate observed was evaluated. Studies were conducted to assess (a) the compatibility of the process and the product with the filters, (b) the compatibility of the filters with the process feed stream and (c) extractables that may be removed from the filters during processing. Implementation of a depth filter and a polishing filter prior to chromatography during the manufacture of a monoclonal antibody successfully removed precipitate observed in the feed stream during column loading without affecting the purification process or the product.

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