RECONSTITUTION METHOD FOR HIGH CONCENTRATION DRY PROTEIN FORMULATIONS

摘要

The present invention relates to the provision of a novel method for the reconstitution of dry formulations comprising biomolecules, and in particular, to dry protein formulations, and to pharmaceutical or veterinary products suitable for parenteral administration containing reconstituted formulations prepared according to the novel method of the invention.

主权项

1. A method for reconstitution of dry formulations comprising biomolecules comprising the following steps:
(i) transfer of a dry formulation comprising said biomolecules into a suitable reconstitution vessel, or preparation of said dry formulation within a suitable reconstitution vessel; (ii) addition of a suitable quantity of an aqueous diluent to said reconstitution vessel; and (iii) centrifugation of the reconstitution vessel at a suitable relative centrifugal force for sufficient time to obtain complete or near complete reconstitution of said dry formulation comprising biomolecules into said aqueous diluent and to produce a biomolecule solution that exhibits minimal or no foaming.