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

摘要

The present invention provides a process for manufacture of purified Nematod e- extracted Anticoagulant Proteins (NAPS), wherein the NAP manufactured by the claimed process method is a NAP drug substance that can be formulated as a N AP drug product. The present invention provides NAP drug substances and NAP dru g products manufactured by the process disclosed herein. In one embodiment, th e 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.