Baxter International Inc.

Baxter Healthcare Sa

Other

Ajinomoto Althea, Inc.

Althea Technologies, Inc.

Altus Pharmaceuticals Inc.

Mark X. Yang

Bhami C. Shenoy

Alexey L. Margolin

Margaret Ellen Mcgrath

Mark X Yang

Bhami Shenoy

Alexey L Margolin

Chandrika Govardhan

Larry Richard Brown

Margaret Ellen McGrath

Ed O'Connell

Julia E Rashba-Step

Ramin Darvari

Adam Lambert

Junhong Zhang

Bhami C Shenoy

Chandrika P Govardhan

This invention relates to crystals of whole antibodies and fragments thereof, and formulations and compositions comprising such crystals. More particularly, methods are provided for the crystallization of high concentrations of whole antibodies, and fragments thereof, in large batches, and for the preparation of stabilized whole antibody crystals for use alone, or in dry or slurry formulations or compositions. This invention also relates to methods for stabilization, storage and delivery of biologically active whole antibody crystals. The present invention further relates to methods using whole antibody crystals, antibody fragment crystals, or compositions or formulations comprising such crystals for biomedical applications, including biological delivery to humans and animals. More particularly, whole antibody crystals or antibody fragment crystals, or crystal compositions or formulations thereof, are used as a carrier-free delivery system which can slowly release active whole antibodies or fragments thereof, to a subject, where and when they are needed.

Methods of crystallizing antibodies

The present disclosure relates to compositions of methods of making and compositions small compositions of particles of an active agent. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spherical particles that are substantially amorphous or non-crystalline and are injectable through fine bore needles at high concentrations. The particles exhibit the pharmacokinetic and pharmacodynamnic properties of the active agent. The disclosure has special application for higher molecular weight proteins such as antibodies.

Protein microspheres retaining pharmacokinetic and pharmacodynamic properties

A method for processing multi-phasic dispersions is provided. The method comprises providing a multi-phasic dispersion including dispersed and continuous phases, providing one or more non-solvents comprising an aqueous solution containing at least one multivalent cation, exposing the multi-phasic dispersion to the non-solvent to form a suspension containing one or more liquid phases and the solid microparticles, and removing at least a portion of the resulting one or more liquid phases while retaining at least the microparticles, thereby removing at least a portion of the non-volatile material from the microparticles.

Methods of processing compositions containing microparticles

This invention relates to crystals of whole antibodies and fragments thereof, and formulations and compositions comprising such crystals. More particularly, methods are provided for the crystallization of high concentrations of whole antibodies, and fragments thereof, in large batches, and for the preparation of stabilized whole antibody crystals for use alone, or in dry or slurry formulations or compositions. This invention also relates to methods for stabilization, storage and delivery of biologically active whole antibody crystals.

Crystals of whole antibodies and fragments thereof and methods for making and using them

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Newton, MA, United States of America

Mark X Yang