Other

Pfizer Corporation

G.d. Searle LLC

Chiron Corporation

Novartis Vaccines & Diagnostics, Gmbh

Gary V Johnson

Robert F Halenbeck

Kirk William Johnson

Glenn J Dorin

Bao-lu Chen

Mark E Gustafson

Hassan Madani

Gary S Bild

Bo H Arve

Gregory L Pattison

Michael Tsang

Maninder S Hora

John H Wagenknecht

Rajsharan K Rana

John J Buckley

David E Steinmeyer

Anurag S Rathore

Maninder S Hoba

Denis M Boyle

Michele Toal

Rejsharan K Bana

Scott I Allen

Serdar Aykent

Stephen B Lyle

John Meyer

Raisharan K Rana

The present invention is directed generally to recombinant methods for making a desired polypeptide. These method(s) yield a polypeptide product containing reduced levels of isoform impurities thereof. In particular, the present invention is directed to (1) a recombinant method for preparing growth hormone with reduced isoform impurities thereof and (2) a recombinant method for preparing a growth hormone antagonist, such as pegvisomant, and its protein intermediate, also having reduced isoform impurities thereof. More specifically, the isoform impurities that are decreased by methods of the present invention are the trisulfide and des-phe isoform impurities of growth hormone and growth hormone antagonist (or its intermediate), respectively.

Method for the preparation of growth hormone and antagonist thereof having lower levels of isoform impurities thereof

The present invention is directed generally to recombinant methods for making a desired pegylated protein and pooling of same. The method(s) yield a polypeptide product containing reduced levels of aggregate thereof pooled to provide the desired pegylated isoforms thereof.

Process for decreasing aggregate levels of pegylated protein

Compositions are described that are suitable for formulating TFPI. Solubilizers and stabilizers facilitate the preparation of pharmaceutically acceptable compositions of TFPI at various concentrations.

Formulation, solubilization, purification, and refolding of tissue factor pathway inhibitor

A method of modifying protein solubility employs polyionic polymers. These facilitate the solubilization, formulation, purification and refolding of proteins especially incorrectly folded proteins and aggregated proteins. Compositions are described that are suitable for formulating TFPI. The compositions allow preparation of pharmaceutically acceptable compositions of TFPI at concentrations above 0.2 mg/mL and above 10 mg/mL.

Method of solubilizing, purifying, and refolding protein

A liquid composition useful for selective dissolution of soft metal is disclosed. The composition comprises an organic nitrocompound and a carboxylic acid. The organic nitrocompound, upon exposure to the soft metal, oxidizes the soft metal to form a first soft metal salt. The carboxylic acid, upon exposure to the soft metal salt, react with the first soft metal salt to form a second soft metal salt that is soluble in the composition. Related methods are also disclosed.

Compositions for dissolution of soft metals

A method for selectively dissolving a soft metal from a substrate of a harder metal by application thereto of an organic nitrocompound and a carboxylic acid. The organic nitrocompound, upon exposure to the soft metal, oxidizes the soft metal to form a first soft metal salt. The carboxylic acid, upon exposure to the soft metal salt, reacts with the first soft metal salt to form a second soft metal salt that is soluble in the composition.

Method for dissolution of soft metals from a substrate of a harder metal

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St. Charles, MI, United States of America

Gary V Johnson