|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. The three resins evaluated are 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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