| 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. Read the rest of this Special Report in the eBook – Just fill out the form to view and download it. |
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I am very interested in the cost evaluation results using Protein A chromatography. I am very glad if you can offer the pdf files to read whole article/ book. Thanks.
Dear sir/madam,
!!! Greeting form Vitane !!!
My self Madhavan omanakuttan working in process development of monoclonal antibody.
One of our monoclonal antibody cleared the pre-clinical stage and now we are in clinical stage ( Disposable platform).
We have also other monoclonal antibody molecules in our pipeline of development.
kindly share the special report for my review.
Regards,
Madhavan Omanakuttan,
Group Leader-Process Development,
EPR Center for Cancer Research & Bioinformatics Pvt Ltd,
Vitane group of company,Plot no 8,Sy no 542 (p).
Genomy Valley Biotech Park,
Shamirpet Mandal,Medchal Dist – 500078
http://www.vitane-bio.com