Methods for producing vaccine adjuvants

摘要

An improved method for the manufacture of an oil-in-water emulsion involves three procedures: (i) preparation of a preliminary emulsion; (ii) microfluidization of the preliminary emulsion to reduce its droplet size; and (iii) filtration of the microfluidized emulsion through a hydrophilic membrane.

主权项

1. A method for the manufacture of a squalene-containing oil-in-water emulsion vaccine adjuvant, the method comprising the step of: (i) formation of a first emulsion having a first average oil droplet size using a mechanical homogenizer, wherein the first emulsion is formed by transferring its components from a first container to a second container through a homogenizer, and then returning them from the second container to the first container through the same homogenizer, wherein substantially all of the emulsion components from the first container are passed through the homogenizer into the second container, and then substantially all of the emulsion components from the second container are passed through the homogenizer back into the first container.