Prion and viral clearance process

摘要

Methods for producing immunoglobulins and in particular anti-D immunoglobulin substantially free of prion and virus, and product resulting therefrom. Specifically provided are methods for nanofiltration of the anti-D immunoglobulin in high ionic strength buffer and with excipient such as polysorbate 80. Additional steps include diafiltration to concentrate the anti-D protein and reduce the concentration of excipient present.