Purification Of Infliximab Analysis
Purification of Infliximab[3] begins at Stage 1 with the filtration of the harvest material using a spin filter. The harvest is then clarified and undergoes 3 main chromatographic steps. Firstly, at Stage 2, the direct protein capture by Protein A affinity chromatography helps to remove a large majority of the impurities whicn include viruses and media components. At Stage 3, prior to cation exchange chromatography, the purified material in the eluted stream is then subjected to freezing, thawing and pooling. Stage 4 involves the Solvent/Detergent (S/D) viral inactivation which is the first dedicated viral clearance step. At Stage 5, the product undergoes cation exchange chromatography which aids in removing the S/D reagents while the product remains bound to the column. The eluted product from Stage 5 is then diluted and put through
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While Protein A affinity chromatography has been extensively applied as the primary purification step for many similar products, it suffers from a few drawbacks like high cost and limited throughput.
As such, the binding capacity on Protein A has become a critical parameter which many organizations have looked into to improve throughput while keeping in mind the economics of the process design. Although manufacturers are introducing and improving newer versions of media which allows for better binding performance, these changes to resin design also have its limitations. For example, decreasing the pore size will increase the overall binding surface area. However, this might lead to an increase in mass transfer resistance and therefore lower capacity at higher flow rates. This trade-off must be carefully analysed and optimized according to the organization’s profit
While Protein A affinity chromatography has been extensively applied as the primary purification step for many similar products, it suffers from a few drawbacks like high cost and limited throughput.
As such, the binding capacity on Protein A has become a critical parameter which many organizations have looked into to improve throughput while keeping in mind the economics of the process design. Although manufacturers are introducing and improving newer versions of media which allows for better binding performance, these changes to resin design also have its limitations. For example, decreasing the pore size will increase the overall binding surface area. However, this might lead to an increase in mass transfer resistance and therefore lower capacity at higher flow rates. This trade-off must be carefully analysed and optimized according to the organization’s profit