Attachment IV - Page 29 
-7- DRAFT 
NOVEMBER 7, 1983 
The use of monoclonal antibodies for affinity purification of recombinant 
DNA products deserves special comment. A document entitled "Points to Consider 
In the Manufacture of Monoclonal Antibody Products for Human Use" already has 
been Issued by the National Center for Drugs and Biologies. The monoclonal 
antibodies should be shown to be free of unwanted biologically active substances 
such as DNA and viruses as described in Section VTI, C. Methods used for the 
coupling of the monoclonal antibody to the column matrix and the removal of 
contaminants from the affinity column should be described. The final product 
should be examined for the presence of antibody and column matrix. 
VII* Characterization of the Product 
Evidence for purity of the product and for the Identity of the product with 
reference preparations may be derived from the results of a wide variety of 
tests. Such tests may Include: 
A. Physicochemical Characterization of Proteins 
1. Compositional Analysis by Amino Acid Analyses 
The complete amino acid composition of the peptide or protein 
should Include accurate values for methionine, 1/2-cystine and tryptophan, which 
may require sample preparation procedures other than hydrolysis In 6bl HC1. 
The amino acid composition presented should be the average of at least three (3) 
separate determinations of the same product or lot number. A positive 
correlation In the results of analyses of the product and reference preparations 
would support arguments for identity. 
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