|It is well recognized that the cost of Protein A resins is substantial. If a developmental monoclonal antibody (MAb) makes it to marketing approval and manufacturing, the high cost of purification using a Protein A resin is amortized over a large number of purification cycles, and the contribution to cost of goods is reduced to acceptable levels. However, a high percentage of clinical projects will fail, and the Protein A resin will be used only for a small number of cycles. Consequently, the cost of using high-performance Protein A is not amortized and therefore will contribute significantly to the MAb developmental cost. One way to address this issue is to use a less expensive Protein A resin designed specifically for early phase clinical trials and subsequently switch to a resin designed for manufacturing if the product makes it through phases 1 and 2. To prevent an increasing regulatory burden from offsetting the potential savings, it is important that the resins perform in a very similar way with respect to purification performance.
This report details a comparability study conducted in high-throughput format to support the strategy of switching resin between phase 2 and 3. Hans J. Johansson from Purolite evaluates the three resins based on the same base matrix and immobilization chemistry and differ only in the type and amount of immobilized Protein A.
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