Manufacture of Vaccines That Contain Both Hepatitis B Virus Surface Antigen and Surfactant

Abstract

When preparing HBsAg for use in a combination vaccine, it is known to add a non-ionic detergent after the HBsAg has been purified. Adding detergents after purification of HBsAg is not optimal, however, as it requires a separate processing step during manufacture. Thus the invention uses them during HBsAg purification.

Description

[0001]All documents cited herein are incorporated by reference in their entirety.TECHNICAL FIELD[0002]This invention is in the field of manufacturing combination vaccines, that is vaccines containing mixed immunogens from more than one pathogen, such that administration of the vaccine can simultaneously immunize a subject against more than one pathogen. In particular, it concerns the use of surfactants during the manufacture of combination vaccines.BACKGROUND ART[0003]Vaccines containing antigens from more than one pathogenic organism within a single dose are known as “multivalent” or “combination” vaccines. Various combination vaccines have been approved for human use in the EU and the USA, including trivalent vaccines for protecting against diphtheria, tetanus and pertussis (“DTP” vaccines) and trivalent vaccines for protecting against measles, mumps and rubella (“MMR” vaccines).[0004]Combination vaccines offer patients the advantage of receiving a reduced number of injections, wh...

AI Technical Summary

Benefits of technology

[0010]Rather than adding non-ionic surfactants to antigens after they have been purified [3,4], the invention uses them during antigen purification. This surfactant can thus perform its function in the final combination vaccine, but the risk of contamination (and thus also the risk of loss of a whole combination vaccine, after it has been prepared) is reduced.

Problems solved by technology

At the same time, however, they present manufacturing difficulties due to factors including: physical and biochemical incompatibility between antigens and other components; immunological interference; and stability.

The inclusion of non-antigen components in vaccines is necessary, but can cause difficulties.

Surfactants are a particular problem in combination vaccines because one antigen may require a surfactant for optimal activity, whereas another may be negatively affected by the surfactant's presence.

Adding detergents after purification of HBsAg is not optimal, however, as it requires a separate processing step during manufacture, which increases the processing time and also increases the risk of introducing contamination into the HBsAg.

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