Patent ID: 9695244
Date: 2017-07-04
CPC Classifications: C07K,G01N

Claim:
1. A method of manufacturing a denosumab drug product, comprising: providing or obtaining a test glycoprotein preparation; acquiring a value for each of a plurality of denosumab parameters listed in Table 1 for the test glycoprotein preparation, wherein the values for the plurality of denosumab parameters distinguishes denosumab from non-denosumab glycoprotein; and wherein the plurality of denosumab parameters comprises parameters 1 and 4 listed in Table 1; and processing at least a portion of the test glycoprotein preparation as a denosumab drug product if the values for the plurality of denosumab parameters for the test glycoprotein preparation meet the corresponding reference criteria shown in Table 1 for the parameters, thereby manufacturing an denosumab drug product, or taking an alternative action if the values for the plurality of denosumab parameters for the test glycoprotein preparation do not meet the corresponding reference criteria shown in Table 1 for the parameters; wherein the test glycoprotein preparation comprises a recombinant antibody composition including a first polypeptide having the amino acid sequence of SEQ ID NO:1 and a second polypeptide having the amino acid sequence of SEQ ID NO:2, and wherein the first and second polypeptides together form a recombinant antibody.