Dyax Corporation

Wyeth

Genetics Institute, Inc.

Other

Brian D Kelley

James Edward Booth

Jeffrey S Deetz

M Daniel Potter

Jinan Yu

Shujun Sun

Suresh Vunnum

Paul Brown

Ranganathan Godavarti

Christopher Gallo

Mary Beth Switzer

Marilous Potter, Legal Representative

Tianning Yu

C Michael Philbrook

Timothy Iskra

Johanna Dalborg

Richard P Northey, Jr

Jonathan Lee Coffman

Anna Petersson

Jane S Tjia

Jon Coffman

Tim Iskra

James E Booth

Daniel M Potter

This invention relates to the application of hydroxyapatite chromatography to the purification of at least one antibody from a preparation containing high molecular weight aggregates. Further, this invention relates to an integration of ceramic hydroxyapatite chromatography into a combination chromatographic protocol for the removal of high molecular weight aggregates from an antibody preparation.

Removal of high molecular weight aggregates using hydroxyapatite chromatography

It is an object of the present invention to provide novel binding molecules for factor VIII and factor VIII-like proteins. Preferred binding molecules of the present invention exhibit not only distinct characteristics for binding of the target factor VIII polypeptides but also specific and desirable characteristics for release (elution) of the target polypeptides. Especially preferred binding molecules according to the invention are short polypeptide sequences, characterized by a stable loop structure.

Binding molecules for human factor VIII and factor VIII-like proteins

This invention relates to methods of using weak partitioning chromatography for the purification of a product from a load fluid containing one or more impurities. Further, the invention relates to methods of weak partitioning chromatography defined by operating conditions which cause a medium to bind least 1 mg of product per mL of medium, or alternatively, defined by a partition coefficient of at least 0.1.

Method of weak partitioning chromatography

Provided herein are methods and compositions for purifying human factor VIII, human factor VIII-like peptide or fragments thereof. The methods comprise immobilizing a binding molecule for human factor VIII, human factor VIII-like protein or fragments thereof to a solid support, contacting the immobilized binding molecule with a solution containing the human factor VIII, human factor VIII-like protein or fragments thereof, and purifying the factor by separating the solution from the solid support.

Methods and compositions for purifying human factor VIII, factor VIII-like proteins or fragments thereof

Methods are provided for purification of Factor VIII polypeptides by affinity chromatography and ion exchange chromatography, in which the eluate from the affinity column is diluted with a solution comprising higher salt concentration, or lower non-polar agent concentration than that of the elution solution, prior to passing the diluted solution through the ion exchange column. The affinity matrix may comprise a monoclonal antibody or a peptide ligand. The methods result in improved purification without significant yield loss.

Methods for producing Factor VIII proteins

Methods are provided for purification of Factor VIII polypeptides by immunoaffinity chromatography and ion exchange chromatography, in which the eluate from the immunoaffinity column is diluted with a solution comprising higher salt concentration, or lower non-polar agent concentration than that of the elution solution, prior to passing the diluted solution through the ion exchange column. The methods result in improved purification without significant yield loss.

Methods for producing factor VIII proteins

Methods for detecting human factor VIII or factor VIII-like polypeptides in and isolating it from solutions such as blood or conditioned media are disclosed, together with reagents suitable for the purpose comprising binding moieties that recognize human factor VIII and/or a factor VIII-like polypeptide and form a binding complex therewith. Preferred polypeptide binding moieties are particularly disclosed.

Polypeptides for binding human factor VIII and fragments of human factor VIII

A formulation is disclosed comprising a pharmaceutically acceptable admixture of an osteogenic protein and a sponge of porous particulate polymer matrix. The sponge may be prepared by treating the porous particulate polymer matrix with a suitable fusing material such as ethanol and a surfactant such as a polysorbate.

Formulations for delivery of osteogenic proteins

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Medford, MA, United States of America

Brian D Kelley