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Composition useful as rotavirus vaccine and a method therefor

一种组合物、病毒的技术，应用在生产这类病毒,制备这类制剂,预防和治疗领域，能够解决有限储存稳定性、不是商业上可行的等问题

Active Publication Date: 2012-05-23
BHARAT BIOTECH INTERNATIONAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of these formulations offer limited storage stability and are therefore not commercially viable

Method used

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  • Composition useful as rotavirus vaccine and a method therefor
  • Composition useful as rotavirus vaccine and a method therefor
  • Composition useful as rotavirus vaccine and a method therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0105] Example 1. Mass production of typical and pretreated rotavirus populations and their stability properties:

[0106] Bharat Biotech International Ltd (BBIL) obtained human rotavirus strains 116E and I321 from NIH under a material transfer agreement with the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), Bethesda, USA. Raw 116E (G9[P11]) and I321 (G10P[11]) were passed through primary African green monkey kidney (AGMK) cells, then MA 104 cell substrates and then serially passaged AGMK (SPAGMK ) cells to adapt to growth in cell culture. MA 104 and SPAGMK cell substrates are not approved by the National Regulatory Agency (NRA) for use in commercial vaccine production. These two human rotavirus vaccine strains (116E and 1321) were therefore adapted to Vero cells, grown individually in these cells to generate a viral bulk population and prepared individually as monovalent, live, attenuated 1. Trial production batche...

Embodiment 2

[0115] Example 2. Typical formulations of rotavirus and pretreated rotavirus in liquid and lyophilized form and the effect of each formulation on the stability profile:

[0116] Store pooled stocks at 2-8°C or -70°C based on 10 3 FFU / 0.5mL to 10 8.5 A target titer of FFU / 0.5 mL was formulated into a semi-finished product and filled as a vaccine. Based on the titer of the pooled stock solution, a calculated volume of the pooled stock solution was withdrawn and added to a predetermined volume of work in progress containing stabilizers, antibiotics and buffers. The formulated semi-finished product is filled into vials as a vaccine. Various stabilizers used in different combinations and concentrations in the formulation are lactalbumin hydrolyzate (LAH), trehalose, sucrose, starch, lactose, maltose, soy protein, rHSA (excluding Any residual rHSA that was carried out with the pretreated virus harvested by the process). Aliquots of 0.5 ml of the virus-containing formulation were...

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PUM

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Abstract

Compositions and methods related to live or live attenuated pre-conditioned and typical viruses such as rotaviruses are disclosed. The live attenuated rotaviruses exhibit better stability characteristics and are useful for the prevention of a rotavirus infection and / or rotavirus gastroenteritis in children.

Description

field of invention [0001] The present invention relates to vaccine formulations containing rotaviruses capable of showing higher titer values, improved stability properties. The formulation can be in liquid or lyophilized form and exhibits increased shelf-life while maintaining its therapeutic effect. The invention also relates to methods of producing such viruses and methods of preparing such preparations. The invention also relates to prophylactic and therapeutic methods using them. Background of the invention [0002] At present, many people are using antiviral vaccines. These human antiviral vaccines include hepatitis A virus vaccine, hepatitis B virus vaccine, influenza virus vaccine, Japanese encephalitis virus vaccine, measles vaccine, mumps vaccine, rubella (MMR) virus vaccine, polio virus vaccine , rabies virus vaccine, smallpox vaccine, varicella-zoster vaccine, yellow fever virus vaccine. In addition to an ever-increasing number of vaccine products, there are ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/15C12N7/00
CPCC12N2720/12334C12N2720/12351C12N7/00A61K2039/5254A61K39/15C12N2999/007A61K39/12A61P31/14A61P37/04
Inventor 克里什纳·莫汉·瓦德雷夫塞尔维·维尔拉巴德兰萨伊·德瓦拉居鲁·普拉萨德
Owner BHARAT BIOTECH INTERNATIONAL
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