The Henry M. Jackson Foundation for the Advancement of Military Medicine Inc.

Fina Biosolutions, LLC

Biosynexus, Inc.

US Government As Represented by the Secretary of the Army

Serum Institute of India Private Limited

The Forsyth Institute

Henry Jackson Foundation

Serum Institute of India Pvt Ltd.

Andrew Lees

James J Mond

Richard F Schuman

Natalia Oganesyan

Gerald Walter Fischer

Frederick J Cassels

Jeffrey R Stinson

Daniel J Smith

Martin A Taubman

Scott Michael Walsh

Anjali G Shah

Min-Ju Chang

Jayant Sakaram Joshi

Joseph J Drabick

Douglas E Shafer

Jayant Joshi

John F Kokai-Kun

Lioubov Grinberg

The present invention is directed to the cells, compositions and methods for the production of recombinant protein, wherein an f-met group on the 5'-terminus is enzymatically removed. In particular, the invention is directed to a production process for obtaining high levels of soluble recombinant CRMprotein from. Cells preferably contain one or more mutations of disulfide reductase genes, so that disulfide reductase activity is reduced. The invention also relates to purification method for CRMas well as characterization of properly folded CRMprotein.

Production of soluble recombinant proteins without N-terminal methionine in

Production of soluble recombinant protein without n-terminal methionine

The present invention is directed to the cells, compositions and methods for the production of recombinant protein. In particular, the invention is directed to a production process for obtaining high levels of soluble recombinant CRMprotein from. Cells preferably contain one or more mutations of disulfide reductase genes, so that disulfide reductase activity is reduced. The invention also relates to purification method for CRMas well as characterization of properly folded CRMprotein.

Expression and purification of CRM proteins and related proteins, and protein domains

Expression and purification of CRM197 and related proteins

This invention provides novel reagents for cyanating polysaccharides in aqueous or part aqueous solutions so that they may be covalently linked to proteins either directly or through a spacer. These reagents include 1-cyano-4-pyrrolidinopyridinium tetrafluoroborate (CPPT), 1-cyano-imidazole (1-CI), 1-cyanobenzotriazole (1-CBT), or 2-cyanopyridazine-3(2H)one (2-CPO), or a functional derivative or modification thereof. The examples illustrate the use of these reagents with a variety of polysaccharides and proteins showing that the methods are generally applicable.

Activation of polysaccharides via the cyanylating agent, 1-cyanobenzotriazole (1-CBT), in the preparation of polysaccharide/protein conjugate vaccines

Activation of polysaccharides via the cyanylating agent, 2-cyanopyridazine-3(2H)-one (2-CPO), in the preparation of polysaccharide/protein conjugate vaccines

Activation of polysaccharides via the cyanylating agent, 1-cyanoimidazole (1-Cl), in the preparation of polysaccharide/protein conjugate vaccines

Activation of polysaccharides via the cyanylating agent, 1-cyano-4-pyrrolidinopyridinium tetrafluoroborate (CPPT), in the preparation of polysaccharide/protein conjugate vaccines

This invention is directed to processes for reducing the level of free carbohydrate from a solution of protein-linked carbohydrate (conjugate) and non-linked carbohydrate. In this process, the conjugate is adsorbed to a hydrophobic membrane while the carbohydrate is not. The conjugate is then desorbed from the membrane, yielding a solution that is substantially reduced in free carbohydrate.

Method of producing protein-carbohydrate vaccines reduced in free carbohydrate

This invention is directed to methods for removing, preferably simultaneously and in one step, multiple impurities form crude culture samples, and, in particular, the removal of media components, protein, nucleic acids, lipids, and lipopolysaccharides to ultralow levels. Preferably the purification process comprises: (1) binding of the target substance containing one or more contaminants to a chromatography matrix; (2) washing the bound target substance with one or more buffers containing a synergistic combination of a lyotropic agent or organic solvent, a detergent, and a salt component; and (3) desorbing the target substance from the chromatography matrix, so that the eluate contains ultra low levels of contaminants. The reduction of impurities that can be achieved is preferably 91-99.9% as compared to the amount of impurities in the target substance before purification. The invention is also directed to the targets products that have been so purified.

Simple method for simultaneous removal of multiple impurities from culture supernatants to ultralow levels

The present invention encompasses monoclonal antibodies that bind to lipoteichoic acid (LTA) of Gram positive bacteria. The antibodies also bind to whole bacteria and enhance phagocytosis and killing of the bacteria in vitro. The invention also provides antibodies having human sequences (chimeric, humanized and human antibodies). The invention also sets forth the variable regions of three antibodies within the invention and presents the striking homology between them.

Nucleic acids encoding opsonic monoclonal and chimeric antibodies specific for lipoteichoic acid of gram positive bacteria

A monoclonal antibody to a consensus peptide of the formula: The monoclonal antibody of the invention binds exclusively to the sequence SAVALTYS (SEQ ID NO:2) and has use as a diagnostic and for prophylaxis against illness arising fromwhich produce the CS4-CFA/I family of proteins and for treatment of disease arising therefrom.

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Water-soluble polymer conjugates of antimicrobial agents retaining at least a portion of the antimicrobial activity of the agent, pharmaceutical compositions containing the polymer conjugates, and methods for treating microbial infections with the pharmaceutical compositions.

Antimicrobial polymer conjugate containing lysostaphin and polyethylene glycol

Opsonic monoclonal and chimeric antibodies specific for lipoteichoic acid of Gram positive bacteria

This invention relates to a process for preparing a hapten-protein-polysaccharide conjugate and a hapten-protein conjugate by reacting a protein with a hapten to produce a hapten-protein conjugate, followed by reacting the hapten-protein conjugate with a polysaccharide to provide a conjugate mixture including the hapten-protein conjugate and a hapten-protein-polysaccharide conjugate. This invention also includes the process described above with the addition of a pharmaceutically acceptable medium or delivery vehicle into the conjugate mixture. The invention further includes the process described above where the hapten is luteinizing hormone releasing hormone peptides derived from, or malaria derived peptides.

Process for preparing conjugate vaccines and the conjugate vaccines

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Silver Spring, MD, United States of America

Andrew Lees