Abstract: 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 unprocessed Botulinum neurotoxin 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.

Abstract: The present invention pertains to recombinant neurotoxin polypeptides and the manufacture thereof. Specifically, it relates to a polynucleotide encoding a neurotoxin polypeptide comprising a light chain, a linker and a heavy chain, wherein the linker is a modified linker comprising an heterologous amino acid sequence which confers at least one physicochemical property to the polypeptide which allows for separation of partially processed and/or unprocessed neurotoxin polypeptides from processed neurotoxin polypeptides, said heterologous amino acid sequence being flanked N- and C-terminally by a protease recognition and cleavage site Further encompassed by the present invention are vectors and host cells comprising the polynucleotide of the invention as well as polypeptides encoded by the polynucleotide and methods for the manufacture of processed neurotoxin polypeptide.

Abstract: 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.

Abstract: Method of measuring an effect induced to a muscle tissue by a clostridial neurotoxin, comprising: (a) contacting a muscle tissue or a cell culture with a sample comprising the clostridial neurotoxin; (c) measuring the effect induced to the muscle tissue by the clostridial neurotoxin; wherein step (c) is performed in the absence of the sample.

Abstract: 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 unprocessed Botulinum neurotoxin 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.

Abstract: 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.

Abstract: The present invention provides a method for providing a muscle relaxant, wherein said muscle relaxant is a reconstituted solution comprising the neurotoxic component of botulinum toxin free of complexing proteins, which exhibits at least one of the following characteristics, more preferably all characteristics a) to d): a. Stable at storage temperatures above 20° C. b. Stable in the presence of preservatives and/or analgesics c. Resistant against “freeze and thaw”-cycles d. Stable if stored in containers of different material.