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Drying process

A technology of active agents and viscous liquids, applied in the field of preserved vaccine compositions, can solve the problems of loss of activity and lack of consistency, and achieve the effects of reducing costs, improving production levels, and short operating cycles

Active Publication Date: 2009-06-10
GLAXOSMITHKLINE BIOLOGICALS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the process is carried out in a large lyophilizer, samples are dried at different rates depending on where they are placed on the rack, which results in different amounts of activity being lost by different samples during the drying process
which leads to a lack of consistency within the same batch

Method used

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preparation example Construction

[0023] Preparation of Preserved Samples

[0024] Any stabilizer is suitable for use in the first step of the invention. Suitable materials include, but are not limited to, all polyhydrocarbyl compounds, both hydrocarbon and non-hydrocarbon polyols. Preferably, the stabilizing polyhydrocarbyl compound enables the active agent to be stored without substantial denaturation, aggregation, or other loss of activity. Particularly suitable materials include sugars, sugar alcohols and hydrocarbon derivatives. Preferably, the polyhydrocarbyl compounds forming the glass are hydrocarbons or derivatives thereof, including glucose, maltulose, isomaltulose, lactulose, sucrose, maltose, lactose, isomaltose, and maltitol , lactitol, isomalt (palatinit), trehalose, raffinose, stachyose, melezitose or dextran, more preferably trehalose, sucrose, sorbitol, raffinose, mannitol, lactose, Lactitol or isomalt, most preferably sucrose, sorbitol, lactose or trehalose.

[0025] Bacterial polysacch...

Embodiment 1

[0115] Embodiment 1 The establishment of freezing conditions

[0116] Prepare samples by dissolving sucrose in water to obtain 1%, 5%, 10% and 20% solutions. Place the samples in a Heto Drywinner 8-85 lyophilizer where the shelf temperature is controlled within 1 °C and the final temperature of the condenser To -85°C, the pressure was regulated through the discharge valve, and 6 thermocouples were used to measure the product temperature. The shelf temperature setting was maintained at 15°C throughout the process. The pressure was initially reduced to 200mBar, maintained at this level for 10 minutes, and then the pressure was further reduced to 50mBar, 5mBar, 2.5mBar, 0.75mBar, 0.4mBar and 0.2mBar. Each pressure level was maintained for 20 minutes so that the temperature reached Equilibrate and read the temperature of the sample with a thermocouple. Thermocouples were connected to the samples with different sucrose concentrations, and the temperatures reported in Table 1 are t...

Embodiment 2

[0122] Example 2 Method of Drying Without Freezing or Foaming

[0123]Preserved samples containing 5%, 10%, 15% and 25% sucrose were prepared and added to vials. Samples were placed in a lyophilizer set at 15°C throughout the process. The pressure was initially reduced to 200 mBar, maintained at this level for 10 minutes to degas, and then the pressure was reduced further. The pressure was further reduced to 8 mbar and maintained for 2-3 hours, during which time a thermocouple within the sample showed a drop in temperature of the sample to 4°C due to evaporative cooling. After 2-3 hours, the temperature of the sample returned to 15°C, which indicated that the evaporation under these temperature and pressure conditions was coming to an end. At this stage of the process, the sample did not boil to form foam or freeze, Thereby exposing the active agent within the sample to as little stress as possible. The sample has the appearance of a viscous liquid.

[0124] The pressure wa...

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Abstract

The present invention relates to immunogenic compositions comprising a dried solid or highly viscous liquid formulation of inactivated polio virus (IPV) and a stabilising agent wherein the IPV retains its antigenicity and / or immunogenicity. Methods of producing a dried formulation of IPV which retains its antigenicity / immunogenicity are described.

Description

technical field [0001] The present invention relates to the preservation of biological samples and other unstable samples, samples so preserved and new processes for preserving said samples. The new process involves adding a sample comprising an active agent and a stabilizer to a container, subjecting the sample to temperature and pressure conditions such that the solvent is lost by evaporation without freezing the sample or frothing the sample to form a foam. Next, in a second drying stage, the pressure and temperature conditions are maintained or adjusted to remove solvent and dry the preserved sample to form a highly viscous liquid. The invention further provides compositions, especially preserved vaccine compositions, preserved by the process of the invention. Background technique [0002] Unstable samples, especially biological samples, require extended stability and thus shelf life. This is traditionally achieved by the lyophilization process, in which a solution of ...

Claims

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Application Information

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IPC IPC(8): C12N1/04
CPCY02A50/30
Inventor Y·马耶尔斯
Owner GLAXOSMITHKLINE BIOLOGICALS SA
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