Method for preparation of site-specific protein conjugates

Details Method for preparation of site-specific protein conjugates Method for preparation of site-specific protein conjugates

C - Chemistry, Metallurgy

07

K

C07K 17/08 (2006.01) A61K 38/28 (2006.01) A61K 47/48 (2006.01) C07K 1/18 (2006.01) C07K 14/62 (2006.01)

Patent

CA 2521381

The invention is directed to a single-step method for rapidly and efficiently preparing protein-polymer conjugates, including an insulin-polymer conjugate. According to the method of the present invention, a protein and hydrophilic polymer are contacted in the presence of at least one organic solvent and at least one metal chelator, under conditions that promote the formation of a conjugate of the protein and polymer. Thus, the invention is directed to the site-specific modification of selected proteins, such as insulin, with poly(ethylene glycol) at residue PheB 1. The invention also provides a pharmaceutical formulation for encapsulating the conjugate in a biodegradable polymer.

L'invention concerne un procédé en une seule étape permettant de préparer de manière rapide et efficace des conjugués protéine-polymère, y compris un conjugué insuline-polymère. Le procédé consiste à mettre en contact une protéine et un polymère hydrophile en présence d'au moins un solvant organique et d'au moins un chélateur métallique, dans des conditions favorisant la formation d'un conjugué de la protéine et du polymère. L'invention vise à modifier de manière spécifique à un site des protéines sélectionnées telles que l'insuline, à l'aide de poly(éthylène glycol), au résidu PheB 1. L'invention concerne aussi une formulation pharmaceutique pour encapsuler le conjugué dans un polymère biodégradable.

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