Stabilizing excipient for inactivated whole virus vaccine
AssigneeSanofi Pasteur Limited
InventorsAlain Francon, Michel Chevalier, Nadege Moreno, Eric Calvosa, Sandrine Cigarini, Virginie Fabre
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Abstract
The invention relates to a vaccine composition comprising: a) inactivated whole virus, and b) a stabilizing excipient which comprises: i. a buffer solution, ii. a mixture of essential and nonessential amino acids, iii. a disaccharide, iv. a polyol, v. a chelating agent, vi. urea or a urea derivative, and vii. a nonionic surfactant.
Claims32
A vaccine composition comprising:
- a) a preparation of inactivated whole rabies virus, and
- b) a stabilizing excipient which comprises:
- i) a buffer solution,
- ii) a mixture of essential and nonessential amino acids,
- iii) a disaccharide,
- iv) a polyol,
- v) a chelating agent,
- vi) urea or a urea derivative, and
- vii) a nonionic surfactant.
A process for preparing a vaccine composition containing a preparation of purified inactivated whole rabies virus, the process comprising:
- a) producing a whole rabies virus preparation by harvesting the supernatant of a virus infected cell culture,
- b) purifying then inactivating the whole virus preparation or, alternatively, inactivating and then purifying the whole virus preparation, and
- c) diluting the preparation of purified inactivated whole virus in a stabilizing excipient, the composition of said stabilizing excipient comprising:
- i) a buffer solution,
- ii) a mixture of essential and nonessential amino acids,
- iii) a disaccharide,
- iv) a polyol,
- v) a chelating agent,
- vi) urea or a urea derivative, and
- vii) a nonionic surfactant.
A stabilizing excipient composition for an inactivated whole rabies virus vaccine, wherein the composition comprises:
- i) a buffer solution,
- ii) a mixture of essential and nonessential amino acids,
- iii) a disaccharide,
- iv) a polyol,
- v) a chelating agent,
- vi) urea or a urea derivative, and
- vii) a nonionic surfactant.
Dependencies are inferred from the claim text.