摘要:
The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.
摘要:
The invention allows substantial improvements in stability of coagulation Factor IX in aqueous compositions. An aqueous composition sealed in a non-glass container comprising Factor IX in a buffer and calcium ions is provided, together with methods of stabilizing an aqueous Factor IX composition comprising storing said composition in a non-glass container for at least 7 days.
摘要:
The invention relates inter alia to a composition which is storage-stable at 25°C for a minimum of 18 weeks comprising a therapeutically effective amount of Factor VIII and an aqueous medium having a Factor VIII potency after 18 weeks of storage at 25° C of at least 90% of the Factor VIII potency of a Control Composition.
摘要:
An aqueous composition comprising a therapeutic protein further characterized in that (i) the pH of the composition is adjusted to be between about 5.9 and 6.3, preferably about 6.1; (ii) the composition comprises at least one displaced buffer having a pKa within 1 to 3 pH units of the pH of the composition such as lactate and TRIS; (iv) the osmolarity of the composition is between 150 - 500 mOsm/L.
摘要:
An aqueous composition having increased protein stability is obtained by: a. determining a pH at which the protein has stability at the desired temperature; b. adding to the composition at least one displacement buffer wherein the displacement buffer has a pKa that is at least 1 unit greater or less than the pH of step (a); and c. adjusting the pH of the composition to the pH of step (a); wherein the aqueous composition does not comprise a conventional buffer at a concentration greater than about 2 mM and wherein the conventional buffer has a pKa that is within 1 unit of the pH of step (a).
摘要:
An aqueous composition which comprises (i) a metalloprotein (or a protein whose structure is dependent on the presence of a metal); (ii) ions of the metal at a concentration of 0 to 20 mM; and (iii) excipients such as buffers and tonicity modifiers, that are relatively weak legands, the composition being substantially free of relatively strong ligands.