Decreasing Cost of Clinical Trials Through the Use of Two Novel Protein A Resins

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Purolite_Downstream-2017-smTackling the High Cost of Protein A in Early Clinical Phases

The cost of Protein A resins is very high, commonly 5-10 times higher compared to standard chromatography resins. One way to address this issue is to use a less expensive Protein A resin during early clinical trials, where the risk of failure is higher and fewer cycles are run, and subsequently switch to a resin designed for manufacturing if the product makes it to PIII and beyond. The higher cost for a manufacturing resin is amortized over a large number of purification cycles. To avoid any increasing regulatory burden offsetting the potential savings, it is important that the two types of resin perform in a very similar way with respect to purification performance.

Process comparisons of such purpose-designed resins in pre-packed, disposable columns show that substantial cost savings can be achieved both during clinical production and commercial manufacturing without compromising performance, buffer consumption or processing time.