PROCESS FOR PRODUCTION OF A VACCINE COMPOSITION

摘要

The present invention relates to a process for production of a vaccine composition, comprising the process steps: i) provision of a volume V₁ of an aqueous phase P₁ comprising an aluminium compound whose surface has been brought into contact with phosphate ions, ii) provision of a volume V₂ of an aqueous phase P₂ of an antigen, iii) addition of the volume V₂ of the aqueous phase P₂ to the volume V₁ of the aqueous phase P₁ with stirring of the volume V₁, whereby at least one, preferably each of the following conditions is fulfilled a) the aluminium compound was heated after the bringing into contact with the phosphate ions and before process step iii); b) the aqueous phase P₁ comprises less than 10 mg/ml aluminium; c) the aqueous phase P₂ comprises less than 1 mg/ml of the antigen; d) the volume V₂ is added with a rate of at most 10 % of the amount of the Volume V₁/minute to volume V₁. The invention also relates to the vaccine composition obtainable by this process, a vaccine composition comprising a substrate and antigen as well as the use of a vaccine composition.