Centocor, Inc.

Invitron Limited

Stephen A Duffy

Christopher P Prior

Randal W Scott

Billy J Moellering

Improved methods for direct purification of product immunoglobulins or their derivatives from large volumes of mammalian cell culture medium include directly subjecting the cell culture medium to cation exchange treatment, so as to adsorb the product but not the contaminants. The eluted product is then recycled, or is applied to anion exchange, for further purification, and optionally subjected to additional steps. The product may be obtained in a form suitable for clinical applications, if desired.

Efficient large-scale purification of immunoglobulins and derivatives

Practical amounts of tissue plasminogen activator (tPA) whether secreted by cells naturally producing it or prepared by recombinant means can be solubilized by providing, in aqueous medium at pH 5-14 8 a solubilizing amount of a basic amino acid optionally and preferably, in the presence of a citric acid moiety. The ability to solubilize tPA at concentrations of up to 50 mg is significant as an aid in permitting smaller volumes for purification and permitting single injections of the drug as opposed to intravenous administration.

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Florissant, MO, United States of America

Stephen A Duffy