Four Protein A resins from leading industry vendors including Amsphere<sup>TM</sup> A3 were screened for use in a capture step for a Herceptin biosimilar. Multiple parameters were assessed for their performance against the incumbent platform resin. Initially, dynamic binding capacity (DBC) determination was made using a standard 4 min residence time using previously purified protein. Performance of the resins were then screened for recovery and purity using harvested cell culture fluid where the mAb load was 80% of DBC at 10% breakthrough. It was observed that using Amsphere A3 in the platform capture process lead to a 40% increase in DBC relative to two of the resins tested including the incumbent resin and a 25% DBC increase over the third comparator resin. Additionally, a better or comparable host cell impurity reduction to other resins was observed. Optimization of the platform capture step was done using Amsphere A3 in place of incumbent resin. An optimal elution buffer system and pH were determined that yielded similar mAb recovery, purity, pH and eluate volume. Subsequently, the DBC was re-evaluated with Amsphere A3 using a range of residence times bracketing the previously tested 4 minutes. An optimized process utilizing 4 min or higher residence times with loads of 70-80% of DBC at 10% BT led to increased recoveries and purity of the Herceptin biosimilar. Both HCP and leached Protein A impurities were within acceptable ranges. It was further shown that filtration of eluate after neutralization led to further reduction in HCP. A capture step has been initially developed using Amsphere A3 that provides significant improvement to the industry standard protein A resins while also demonstrating comparable or superior HCP profile, mAb recovery and leached protein A.<br/>® Herceptin is a registered trademark of Genentech, Inc.<br/>

Optimization of protein A chromatography process for a Herceptin® biosimilar (trastuzumab)

253rd National Meeting (2017)

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