PROCESS FOR MANUFACTURE OF NEMATODE-EXTRACTED ANTICOAGULANT PROTEIN (NAP)

摘要

The present invention provides a process for manufacture of purified Nematode-extracted Anticoagulant Proteins (NAPS), wherein the NAP manufactured by the claimed process method is a NAP drug substance that can be formulated as a NAP drug product. The present invention provides NAP drug substances and NAP drug products manufactured by the process disclosed herein. In one embodiment, the present invention provides a process for manufacture of rNAPc2/proline drug substance and rNAPc2/proline drug product, and provides rNAPc2/proline drug substance manufactured by the process disclosed herein.