Stable galenic freeze-dried pharmaceutical preparation of recombinant carbohydrate-binding polypeptides
AssigneeViscum AG
InventorsOliver Gloger, Bernd W. Müller, Klaus Witthohn
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Abstract
The invention relates to a method for the production of a medicament containing a polypeptide comprising at least one recombinant carbohydrate-binding polypeptide, or a functional fragment or derivative of said carbohydrate-binding polypeptide in a form stable for storage. The polypeptide mentioned comprises polypeptides or functional derivatives thereof, which are fused with cytotoxically effective peptides to give fusion proteins, or which are linked to another polypeptide having a cytotoxic activity. Moreover, the invention describes further formulating of the disclosed medicaments to medicaments with different pharmaceutical forms.
Claims35
A method for the production of a medicament containing a polypeptide comprising at least one recombinant carbohydrate-binding polypeptide or a functional fragment or derivative of said carbohydrate-binding polypeptide wherein
- (a) the polypeptide or a functional fragment or derivative of this polypeptide which is fused to a cytotoxically effective peptide to form a fusion protein;
- (b) the polypeptide or a functional fragment or derivative of this polypeptide which is linked to another polypeptide which has an enzymatic rRNA-N-glycosidase activity;
- (c) the polypeptide or a functional fragment or derivative of this polypeptide which is linked to another polypeptide in which an enzymatic rRNA-N-glycosidase activity has been replaced by another cytotoxic activity;
- or
- (d) the polypeptide or a functional fragment or derivative of this polypeptide, which is linked to a fusion protein, comprising a polypeptide with an enzymatic rRNA-N-glycosidase activity and/or another cytotoxic activity;
- in a form stable for long-time storage, moreover optionally containing a pharmaceutically acceptable carrier,
- comprising the step of cooling, freezing, spray drying or lyophilising while retaining the pharmacological properties of the polypeptide in the solution, wherein the solution is characterised in that the pH value of the solution is higher than pH 6.0 and a buffer system contained in the solvent guarantees that this pH-value is maintained.
Dependencies are inferred from the claim text.