Miles Inc.

Cutter Laboratories, Inc.

Michael A Fournel

Pamela C Esmon

Paul K Ng

A method for evaluating the potential immunogenicity of a protein derived from recombinant DNA technology. The method involves injecting an animal with the recombinant protein and then isolating antiserum from the animal. The antiserum is depleted of antibodies to a reference protein, i.e., a plasma derived protein, by adsorbing the antiserum against the reference protein. The adsorbed antiserum is then blotted against the recombinant protein, to see if any antibodies were produced which recognize the recombinant protein, but did not recognize the plasma-derived protein during adsorption.

Method for evaluating immunogenicity

Stable plasma protein fractions (PPF) substantially free of vasodepressant amounts of acetate ions are disclosed. Solutions of the disclosed PPF are suitable for intravenous administration to patients without deleterious vasodepressor effects. Methods are also described for preparing the aforementioned PPF.

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Castro Valley, CA, United States of America

Michael A Fournel