Protein based affinity chromatography media (resins) give excellent purification factors and can result in &gt; 99 % purity in one single step. Generic conditions often used also enable a platform approach to downstream processing. A disadvantage with protein based chromatography ligands is that they can be susceptible to harsh conditions required for sanitization-in-place (SIP), especially for reduction of spore forming bacteria, which are very resistant.<br/><br/>The aim of this work was to develop efficient SIP methods for different affinity chromatography media for reduction of both vegetative and spore forming bacteria. Investigation of chromatography media compatibility in novel SIP agent solutions were performed using high-throughput formats, i.e. 96-well filter plates with chromatography media and mini-columns. Potential effects on kinetics, and ligand modifications were studied using analytical methods such as Surface Plasmon Resonance (SPR) and Mass spectrometry (MS). The impact of SIP chemicals on hardware and single-use components will also be discussed.<br/>

Thorough investigation of the effect of novel sanitization agents on affinity chromatography media

249th National Meeting (2015)

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