métodos para preservar um polipeptídeo e um imunógeno de vacina, e para preparar uma vacina, pó seco, produto preservado, frasco selado, ampola ou seringa, uso de um excipiente, e, vacina.

摘要

A method for preserving a polypeptide comprises (i) providing an aqueous solution of one or more sugars, a polyethyleneimine and said polypeptide wherein the concentration of polyethyleneimine is 25 μM or less based on the number-average molar mass (Mn) of the polyethyleneimine and the sugar concentration or, if more than one sugar is present, total sugar concentration is greater than 0.1 M; and (ii) drying the solution to form an amorphous solid matrix comprising said polypeptide.