Capture resins employing affinity based separation using proteinatious ligands currently play a major role in the purification of biomolecules for their biopharmaceutical application. Due to the large contribution of these capture resins to the overall COGS of a product, optimization of resin lifetime is imperative. This is complicated by the less harsh regeneration and cleaning solutions that a proteinatious ligand can be subjected to in comparison to chromatigraphic media with chemical moeties as ligands. In order to optimze resin lifetime, cleaning in place and regeneration of the chromatographic material needs to be optimized.<br/>In order to gain better understanding of the effects of cleaning and regeneration buffers and in order to optimize throughput of testing and minimize material needs, automated and miniaturized procedures were developed and implemented. Using MabSelect (GE Healthcare Life Sciences) and a Tecan EVO200 robotic station, both automated lifetime studies and accelerated fouling procedures were set up. The focus of the presented automated lifetime study is the screening of cleaning-in-place (CIP) buffers, which effectively remove remaining protein and contaminants.The accelerated resin fouling, characterized by repeated cycles of equilibration, load and elution without a wash step was implemented to gain fouled protein A resin. Afterwards, several commonly used regeneration buffers were examined for their efficacies to clean the fouled resin using batch wise incubation of 25 μL resin on filter plates.<br/>The presentation will include details on the experimental setup, results from screening a wide range of cleaning solutions, and experience from scaled-up experiments.

Automated and miniturized ProteinA affinity resin lifetime optimization studies

253rd National Meeting (2017)

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