Wednesday, 16 May 2007
3rd Floor Hall (Pfahler Hall)
168

Effect of process cycling on Protein A resin used in the production of monoclonal antibody therapeutics

Denise M. Goodroad, Muthuramanan Rameswaren, Aaron Meyers, and Kristopher A. Barnthouse. Global Biologics Supply Chain, Johnson & Johnson, Malvern, PA

Protein A chromatography resin is utilized for the product capture step in the production of a new monoclonal antibody therapeutic. It has been noted that relevant cleaning solution exposure guidelines are available from the resin manufacturer, however use limits for use in manufacturing have not yet been established for this resin. The effect of process cycling on Protein A resin was examined at laboratory scale to prospectively establish resin lifetime and exposure limits specific to the new manufacturing process. Resin cleaning and sanitization agents are expected to be lifetime limiting in this application. The resin was exposed to repeated process cycles including the use of sanitization agents with intermittent product load cycles. The effect of this cycling was measured by product eluate recovery and purity across 200 cycles. As the number of process cycles and exposure hours to the sanitization agents increased, the product eluate recovery decreased while no effect on product purity was observed. Based on this data, maximum resin use cycles and exposure time to sanitzation agents will be recommended.

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