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Stabilized non-enveloped virus compositions

An enveloped virus, composition technology, applied in the direction of viruses, antiviral agents, viral antigen components, etc., can solve problems such as very sensitive interactions

Pending Publication Date: 2021-09-24
ZICCUM AB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the viral surface structure of non-enveloped viruses such as adenoviruses is also very sensitive to conformational changes and interactions with different reagents used to formulate the virus or virus parts

Method used

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  • Stabilized non-enveloped virus compositions
  • Stabilized non-enveloped virus compositions
  • Stabilized non-enveloped virus compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0044] Materials and Methods

[0045] Inactivated EDS adenovirus: from HesterBiosciences Limited, Gujarat, India (www.hester.in) and from the State Veterinary Office of Sweden, Uppsala, Sweden , Uppsala) (SVA).

[0046] The iEDS virus preparation from SVA was supplied as a clear suspension of virus with a hemagglutinin assay (HA) titer of 64-128.

[0047] The virus preparation from Hester was formulated as a vaccine. In a double extraction procedure, 5% sodium cholate solution was used to extract the conceived virus from the vaccine. The clear second extract was freed of cholate by chromatography on Sephadex G-75 equilibrated with 7 mM phosphate buffer, pH 7.5. Material eluted in the void volume of the gel was assessed by HA analysis of viral activity, and active fractions were pooled.

[0048] A 20% solution of 2-hydroxypropyl-β-cyclodextrin was added to either virus suspension to a final concentration of 2%. A 5 mL sample of the suspension was then applied to the nebuli...

example 2

[0063] Example 2 compares EDS virus activity before and after the spray drying method and excipients according to the invention. In Example 2, inactivated EDS virus was obtained from GD animal health and the following protocol was used for the hemagglutination (HA) test of virus activity.

[0064] Hemagglutination test (HA)

[0065] equipment and materials

[0066] Use the following equipment. Benchtop centrifuge with appropriate accessories. Erythrocytes from appropriate hosts in Alsevers solution (Sigma-aldrich code A3551). Alsevers solution is composed of 4.2g / L NaCl, 8.0g / L citric acid·3Na·2H 2 O, 0.55g / L citric acid H2O, 20.5g / L D-glucose, and used as an anticoagulant / blood preservative. V-bottom 96-well plate, PBS solution

[0067] red blood cell preparation

[0068] chicken blood in AB Purchase (https: / / www.hatunalab.com / en-GB). For chicken blood, order 2ml whole blood, this should be mixed with 2ml of Alsevers solution.

[0069] Preparation of RBC solution

...

example 3

[0101] Preliminary experiments used inactivated EDS adenovirus extracts: Hyster Biosciences Ltd., Gujarat, India (see Example 1) and albumin, dextran and glycine (at similar or identical concentrations to HPBCD in previous examples, respectively). as excipient) and using the same spray drying process as defined in Examples 1 and 2. The results demonstrated that the yield after the spray drying process was high, and the HA assay maintained the viability of the virus immediately. However, compared to Examples 1 and 2 using HPBC as excipient, viral activity was significantly lost during storage at 40°C. These results confirm that the above-described Laminar Pace process for spray drying allows for drying conditions that are favorable for maintaining viral activity and yield, whereas in the given case, neither of these excipients allow the desired thermal stability.

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Abstract

The present invention relates to methods and compositions of thermostable nonenveloped virus as obtained by a laminar counter-current spray drying process. The compositions comprise aerosolizable amorphous particles, comprising free, non-encapsulated nonenveloped virus and an excipient, wherein the particles typically have a mass median aerodynamic diameter (MMAD) of less 5 mum and comprise less than 5% water.

Description

technical field [0001] The present invention generally relates to a thermally stable aerosolizable non-enveloped virus composition comprising a non-enveloped virus produced by a laminar spray drying process. Background technique [0002] Vaccines are usually distributed from manufacturers to users under strictly controlled conditions, including cold chains, as recommended by WHO guidelines. Stability during storage and distribution is a common concern for vaccines and other biological agents, especially when vaccinations are required in remote areas with restricted cold chains or inaccessibility. For this reason, dry powdered vaccines (DPVs) are attractive as they are potentially more stable for storage, but considerations need to be given to the production drying process and subsequent packaging and delivery systems. Eur. J. Pharm and Biopharm., 2018, Vol. 122, pp. 167-175 by T.F. Bahamondez-Canas et al. The need for stable vaccines against drugs, while reviewing contempo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16C12N1/04C12N7/00A61K35/761A61K9/00A61K39/12
CPCC12N7/00A61K9/0073A61K9/0043A61K9/1652A61K39/12A61K2039/5252A61P31/20C12N2710/10234C12N2710/10251A61K39/235
Inventor G·康拉德松F·阿塞韦多丰塞卡
Owner ZICCUM AB
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