Miles Inc.

Miles Laboratories, Inc.

James E Brown

Cynthia A Cowgill

An immunoassay for cellular proteins which may be present as contaminants in a product purified from mammalian cell culture. Since mammalian cell culture requires the use of protein-containing media, the assay must be specific in recognizing cellular proteins but not media proteins. This is accomplished by selective adsorption of an antiserum to cellular proteins against media proteins. Quantification of the assay may be improved through the use of a purified antigen, namely fibronectin, which is known to be highly immunogenic.

Immunoassay for cell proteins

Affinity purification of Factor VIII:C, both plasma derived and genetically engineered, using coupled phosphatidylserine (PS) as the predominant phospholipid (PH) results in a high degree of purity of Factor VIII:C, similar to that previously demonstrated with monoclonal antibodies specific to either Factor VIII:C or von Willebrand factor. Phospholipids that can be used in combination with PS are phosphatidycholine (PC) and phosphatidylethanolamine (PE).

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Lafayette, CA, United States of America

James E Brown