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.