THERMOSTABLE RESPIRATORY SYNCTIAL VIRUS (RSV) VACCINE COMPOSITIONS

摘要

Methods for improving the drying yield and stability of RSV vaccines comprising a highly thermolabile enveloped live virus and/or one or more RSV protein subunits, are described. Methods for rapid drying of RSV formulations containing between 17.5% and 60% w/w of a non-polymeric sugar and using either conduction or radiation dominant drying mechanisms, are disclosed. The disclosed methods provide for; 1) a dried RSV formulation with improved stability profile; 2) faster drying; and 3) integration of dried RSV into a primary device (such as dual chamber cartridges, foil-pouch devices etc.), pre- as well as post-drying.

主权项

1. A method for drying a vaccine composition comprising a live attenuated respiratory syncytial virus (RSV) or one or more RSV protein subunits comprising the steps of:
a) providing an aqueous composition in a primary container comprising the live attenuated RSV or one or more RSV protein subunits, a buffer, and from 17.5% w/w to 60% w/w of one or more non-polymeric sugars, wherein the pH of the buffer is between 6 and 8; b) freezing the aqueous composition, thereby forming at least one frozen body comprising the buffer in frozen form; and c) drying the aqueous composition by using a conduction or a radiation dominant drying mechanism.