It is well recognized that the cost of Protein A resins is substantial. If a product makes it to marketing approval and manufacturing the high cost is amortized over a large number of purification cycles then the contribution to cost of goods is acceptable. However, a high percentage of clinical projects will fail and the Protein A resin will only be used for a small number of cycles. One way to address this issue is to use a less expensive…
Author Archives: Duncan Sinclair
A Fresh Approach to Process and Cost Efficiencies in Early Clinical and Biosimilars Production
This poster will introduce Praestoâ„¢ AC protein A resin and ProcessReady pre-packed columns from Purolite. Platform processes for MAbs manufacturing have long been used to save time and costs. The use of highly productive, cost- effective resins in such platforms can magnify these savings, and the addition of ready-to use formats can further enhance process efficiencies. Our approach is to maximize these efficiencies and cost savings in early clinical-phase production and in the manufacture of biosimilars by using stage-appropriate materials…