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Concentration of vaccine antigens without lyophilization

An antigen and vaccine technology, applied in vaccines, multivalent vaccines, virus antigen components, etc.

Inactive Publication Date: 2013-05-08
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

These techniques deliver smaller volumes than the usual 0.5ml intramuscular injection, but they may require the same amount of antigen, often more concentrated bulk antigen

Method used

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  • Concentration of vaccine antigens without lyophilization
  • Concentration of vaccine antigens without lyophilization
  • Concentration of vaccine antigens without lyophilization

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Embodiment Construction

[0188] Effect of Freeze-drying on Influenza Virus Hemagglutinin

[0189] Monovalent influenza virus bulk antigens were analyzed by size exclusion chromatography (SEC) and then reanalyzed after lyophilization and reconstitution. Two different lyophilization procedures were tested: one using sucrose alone as a lyoprotectant and one using sucrose and mannitol. The results in Figure 1 show a main peak at 5 minutes ( Figure 1A ) disappear in the reconstructed material ( Figure 1B and 1C ). Antigen concentration should therefore avoid lyophilization, as this treatment significantly alters the vaccine antigen.

[0190] Comparison of Antigen Concentration Techniques

[0191] The starting HA concentration in the monovalent influenza virus bulk was about 0.5 mg / ml. Concentrate various bulk materials using three different methods: Centrifugal Filtration, Ultrafiltration and TFF. Centrifugal filtration using Millipore with a cut-off of 10kDa TM equipment, run at 5000rpm for 45 mi...

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Abstract

An antigen concentration procedure does not involve lyophilisation of a bulk antigen before its final formulation and / or delivery. Thus a process for preparing a vaccine comprises steps of (i) increasing the concentration of an antigen in a liquid composition including that antigen, to provide a concentrated antigen, and (ii) formulating a vaccine from the concentrated antigen. The concentrated antigen is not lyophilised between or during steps (i) and (ii). The invention is particularly useful for preparing solid vaccine forms.

Description

[0001] This application claims the benefit of US Provisional Application 61 / 396,719, filed June 1, 2010, and US Provisional Application 61 / 465,405, filed March 18, 2011, both of which are incorporated herein by reference in their entirety. technical field [0002] The present invention relates to the field of processing antigen solutions for use in vaccines. technical background [0003] It often happens during vaccine manufacture that the antigen concentration in the bulk production exceeds the concentration in the final patient formulation, so the method involves a step of dilution of this bulk. In some cases, however, it is desirable to increase the antigen concentration in the aqueous bulk, and the present invention relates to methods of concentrating the antigen. A useful approach would be to increase the concentration of the antigen without destroying its immunogenicity. [0004] One situation where antigen concentration is required is for new delivery technologies th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/145
CPCA61K39/145C12N2760/16234C12N2760/16134C12N2760/16151C12N7/00C12N2760/16251A61K2039/55566A61K2039/70A61K39/12C07K1/34C07K14/005A61P31/16C12N2760/16334C12N2760/16351
Inventor S·科玛莱迪A·斯卡皮尼B·宝德纳D·欧哈根M·辛格
Owner NOVARTIS AG