As the global market for biosimilars expands, scientists are required to rapidly develop and optimize robust manufacturing processes quickly under constrained timelines. A typical three-column mAb purification platform features Protein A capture followed by any two of the following polishing chromatography steps: Cation Exchange (CEX), Anion Exchange (AEX), or Hydrophobic Interaction Chromatography (HIC). With several next generation purification media and ion exchange membranes, there are several opportunities to reduce the number of chromatography steps and create process intensification through high-throughput platform purification schemes.<br/>In this work, multiple two-column platforms were developed that combined the use of a newer high capacity Protein A resin, CEX chromatography or a depth filtration step, and either AEX traditional chromatography or membrane chromatography as a polishing step. Each platform described in this work is effective at generating the model molecule trastuzumab at &lt; 0.5 % aggregate and &lt; 20 ng/mg Host Cell Protein (HCP) while maintaining an overall process yield of ≥ 75%. The advancements described in each platform decrease the time required for development and technical transfer to manufacturing scale.

Flexibility in high-throughput two column purification platforms for biosimilar mAb manufacturing

251st National Meeting (2016)

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