University of Michigan

Novo Nordisk A/s

The Ohio State University

Jichao Kang

Steven Paul Schwendeman

Jeffrey Alan Hubbell

Shawn DeFrees

David A Zopf

Robert J Bayer

Hanne Bentz

Walter Scott Willett

Anna S Shenderova

Samuel E Reinhold, Iii

Wenlei Jiang

A method for encapsulating a biomacromolecule in a pore-containing polymer comprising the steps of providing an encapsulating solution containing the biomacromolecule and the pore-containing polymer; contacting the biomacromolecule with the pore-containing polymer for a time sufficient for the biomacromolecule to enter the pores of the pore-containing polymer; and rearranging the polymer such that the surface pores of the polymer are closed thus encapsulating the biomacromolecule in the pore-containing polymer.

Methods for encapsulation of biomacromolecules in polymers

The present invention provides conjugates between erythropoietin and PEG moieties. The conjugates are linked via an intact glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. The conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.

Glycopegylated erythropoietin formulations

Methods for reducing or inhibiting the irreversible inactivation of water-soluble biologically active agents in biodegradable polymeric delivery systems which are designed to release such agents over a prolonged period of time, such as PLGA delivery systems are provided. The method comprises preparing a PLGA delivery systems whose microclimate, i.e. the pores where the active agent resides, uniformly or homogenously maintain a pH of between 3 and 9, preferably between 4 and 8, more preferably between 5 and 7.5 during biodegradation. Depending on the size of the delivery system, and the initial bulk permeability of the polymer, this result is achieved by (a) incorporating a water-soluble carrier into the delivery system, (b) incorporating a select basic additive (or antacid) into the delivery system, (c) incorporating both a water soluble carrier and a select basic additive into the delivery system, (d) adding a pore forming molecule for increasing the rate of release of low molecular weight monomers and oligomers into the delivery system, (e) using a PLGA polymer with reduced glycolide content, i.e. PLGA with from 100% to 75% lactide and 0 to 25% glycolide) (f) using a microencapsulation method that yields a more extensive pore-network, e.g. oil-in-oil emulsion-solvent extraction as opposed to water-in-oil-in water-solvent evaporation method, and (g) combinations thereof.

Methods for stabilizing biologically active agents encapsulated in biodegradable controlled-release polymers

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Pennington, NJ, United States of America

Jichao Kang