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US 2009/0214472 A1Published application
Interferon-beta polymer conjugates
AssigneeEnzon Pharmaceuticals, Inc.
InventorsDavid Ray Filpula, Karen Yang, Amartya Basu, Maoliang Wang
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Abstract
Biologically-active, interferon-beta 1b-polymer conjugate compositions are disclosed. The polymer portion is preferably a polyalkylene oxide polymer having a molecular weight of at least about 12 kDa. Methods of making and using the same are also disclosed.
Claims54
A composition comprising:
- a) interferon conjugated to a polyalkylene oxide polymer having a molecular weight of at least about 12 kDa;
- and optionally
- b) a surfactant;
- c) an excipient, and
- d) a buffer
- wherein the pH range of the solution is from about 3 to about 11.
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A composition comprising:
- a) 0.05 to 3.0 mg/ml of interferon beta 1b conjugated to a polyalkylene oxide polymer having a molecular weight of at least about 12 kDa,
- b) 1%-5% mannitol, and
- c) 3-10 mM acetic acid
- wherein the pH is about 3.7.
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A method of preparing a polyalkylene oxide-protein conjugate comprising the steps of
- (a) solubilizing a protein of interest in a compatible aqueous solution in the presence of a protein-solubilizing amount of a compatible detergent;
- (b) reacting the solubilized protein of interest with an activated polyalkylene oxide polymer, to produce a solution comprising a polyalkylene oxide-protein conjugate and the detergent;
- (c) adjusting the reacted solution of step (b) to a pH effective to dissociate the detergent from the polyalkylene oxide-protein conjugate;
- (d) separating the dissociated detergent from the polyalkylene oxide-protein conjugate, and recovering the polyalkylene oxide-protein conjugate.
1 more element
Dependencies are inferred from the claim text.