Merz Pharma Gmbh & Co Kgaa

Harold Victor Taylor

Karl-Heinz Eisele

Cornelia Brunn

Michael Pfeil

Gerd J Mander

Josef Friedrich

Markus Burger

Cornelia Brünn

Thomas Wilk

The present invention pertains to pharmaceutical compositions which comprise botulinum toxin from. The pharmaceutical compositions of the instant invention are not only free of a mammalian derived proteinaceous stabilizing agent but are free of any stabilizing protein.

Therapeutic composition with a botulinum neurotoxin

The present invention relates to an antibody which specifically binds to unprocessed and/or partially processed neurotoxin polypeptide or an antibody which specifically binds an epitope consisting of a peptide having an amino acid sequence as shown in any one of SEQ ID NOs: 1 to 16 and to methods for the manufacture of such antibodies. Moreover, the present invention relates to a composition comprising processed neurotoxin polypeptide free of unprocessed or partially processed neurotoxin polypeptide and a method for manufacturing said neurotoxin polypeptide based on the antibodies of the invention. The present invention also relates to the use of the aforementioned antibody for separating processed neurotoxin polypeptides from unprocessed or partially processed neurotoxin polypeptides or for determining unprocessed or partially processed neurotoxin polypeptides. The present invention relates to a method for the manufacture of a medicament.

Antibody that specifically binds partially processed or unprocessed neurotoxin polypeptides

Means and methods for manufacturing highly pure neurotoxin

Novel methods for determining the unknown biological activity of a clostridial neurotoxin in a sample with respect to the known biological activity of a clostridial neurotoxin in a reference sample, comprising the step of comparing the biological activity of a clostridial neurotoxin preparation with the biological activity of a standard preparation of a reference clostridial neurotoxin in certain in vitro systems.

In vitro assay for quantifying clostridial neurotoxin activity

The present invention pertains to pharmaceutical compositions which comprise a botulinum neurotoxin from, the neurotoxin being free of the complexing proteins naturally present in the botulinum neurotoxin complex or being chemically modified or being modified by genetic manipulation. Moreover the pharmaceutical compositions of the instant invention have good stability and are advantageously formulated free of human serum albumin.

The present invention is concerned with tools for the quality control and safety during manufacture of neurotoxins. In particular, it relates to a method for the determination of the amount of partially processed and/or unprocessedneurotoxin A polypeptide (BoNT/A) in a solution comprising processed and partially processed and/or unprocessed BoNT/A comprising the steps of contacting a sample of the solution with a capture antibody which specifically binds to the partially processed and unprocessed BoNT/A under conditions which allow for binding of the antibody to the partially processed and unprocessed BoNT/A, whereby a complex is formed, and determining the amount of the formed complex, whereby the amount of the complex is indicative for the amount of the partially processed and/or unprocessed BoNT/A in the solution. Moreover, the present invention contemplates a device and a kit for carrying out the method.

System for determining unprocessed and partially processed neurotoxin type A

The present invention pertains to a formulation comprising a hydrophilic polymer, a mixture of a polyalcohol and a sugar, wherein the weight ratio of polyalcohol to sugar is between 2:1 to 5:1 (wt-%), a detergent, and wherein the formulation is free of stabilizing proteins.

Formulation for stabilizing proteins, which is free of mammalian excipient

A formulation free of protein which stabilizes pharmaceutical active proteins, peptides, or mixtures thereof in large scale production processes comprising a mixture of a hydrophilic polymer and a non-ionic detergent, and a mixture of a polyalcohol and a sugar. In some embodiments the polyalcohol is absent.

Growing community of inventors

Frankfurt am Main, Germany

Harold Victor Taylor