Stable transglutaminase preparations and processes for their production
AssigneeAventis Behring GmbH
InventorsHubert Metzner, Hermann Karges
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AssigneeAventis Behring GmbH
InventorsHubert Metzner, Hermann Karges
Estimating the term…
The present invention relates to stable preparation forms of a transglutaminase, for example factor XIII, which, after lyophilization, are readily soluble without turbidity. The preparation froms comprise, in addition to the transglutaminase additives selected from the group consisting of D- and/or L-amino acids other than glycine and arginine, their salts, derivatives and homologs, or dimers or oligomers thereof or mixtures thereof, and sugars or sugar alcohols. The formulations may also comprise surface active agents and/or reducing agents. The invention provides processes for preparing stable protein preparations and to the use of the described stable preparation forms for producing pharmaceuticals which are suitable, for example, for treating diseases which are characterized by F XIII deficiency.
A stable lyophilized transglutaminase formulation, comprising at least one additive selected from the group consisting of:
A process for preparing a stable protein transglutaminase comprising mixing a purified transglutaminase with an aqueous solution suitable for parenteral administration to a human patient and lyophilizing the resultant mixture wherein said solution comprises at least one additive selected from the group consisting of:
Dependencies are inferred from the claim text.