(506e) Impact of Clarification Treatment On Protein A Purification

Technology advances in the biopharmaceutical industry have resulted in significant increases in MAb titer and cell densities. Current clarification technologies such as centrifugation and depth filtration are struggling to keep up with more challenging feeds. There is a clear need for alternative clarification techniques and a focus has been on precipitation technologies.  Precipitation technologies have the potential to remove both cells and impurities in a single step, thus compressing the downstream process. EMD Millipore has developed a smart polymer along with the Clarisolve™ filter for clarification of MAbs.  The solution provides a disposable clarification option up to 2000 L and also provides significant DNA clearance.  The impact of using smart polymer on subsequent purification steps was investigated.  Results indicate that smart polymer offers advantages beyond clarification alone.  Data will be presented which illustrates that the use of smart polymer provides enhanced Protein A purification and an improvement in the Protein A elution pool stability.