Abstract: A pharmaceutical preparation comprising a growth hormone and histidine or a derivative of histidine as additive or buffering substance shows a very high stability against deamidation, oxidation and cleavage of peptide bonds. The stability of the product allows for the storing and shipment thereof in a lyophilized state or in the form of a dissolved or re-dissolved preparation at ambient temperature. Crystallization of growth hormone in the presence of histidine or a derivative thereof gives rise to a higher yield of crystals having a higher purity than known methods.
Type:
Grant
Filed:
June 2, 1995
Date of Patent:
December 15, 1998
Assignee:
Novo Nordisk A/S
Inventors:
Hans Holmegaard S.o slashed.rensen, Lars Skriver, Annie Rassing Hoelgaard
Abstract: A coagulation active complex of Factor VIII fragments is produced by causing coagulation inactive FVIII heavy chain to react with coagulation inactive FVIII light chain in the presence of a complex forming agent. Thus, FVIII-HC and FVIII-LC are converted to coagulation active FVIII complex in the presence of divalent metal ions, such as Mn.sup.2+, Ca.sup.2+ or C.sup.2+, or a component of the pro-thrombin complex.