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Live attenuated influenza vaccine composition and process for preparation thereof

A composition and influenza technology, applied in biochemical equipment and methods, medical preparations with non-active ingredients, polymer compounds with non-effective ingredients, etc., can solve problems such as no suitable chromatographic steps

Pending Publication Date: 2021-11-12
SERUM INST OF INDIA PTE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The present disclosure further provides improved manufacturing methods utilizing low concentrations of endonucleases, more specifically benzoidases, and no chromatography steps suitable for large-scale cell culture production

Method used

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  • Live attenuated influenza vaccine composition and process for preparation thereof
  • Live attenuated influenza vaccine composition and process for preparation thereof
  • Live attenuated influenza vaccine composition and process for preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0224] Example 1: Stability data of rearranged LAIV virus immunogenic compositions

[0225] Component 1 - Live Attenuated Influenza Vaccine Virus (LAIV)

[0226] Influenza vaccine viruses are rearranged LAIV viruses derived by typical rearrangement methods that include the cold-adapted, temperature-sensitive and / or attenuated phenotypic genes of the master donor virus (MDV) in a 6:2 or 7:1 ratio Segments and hemagglutinin (HA) gene segments and / or neuraminidase (NA) gene segments of wild-type pandemic or seasonal influenza A or influenza B or influenza C strains.

[0227]

[0228]

[0229] For LAIV immunogenic compositions:

[0230] In the range of 6 to 7 log EID50 / 0.5 ml dose; more preferably 7 log EID50 / 0.5 ml dose of A virus

[0231] In the range of 6 to 7 log EID50 / 0.5 ml dose; more preferably 6.5 log EID50 / 0.5 ml dose of B virus

[0232] With respect to the rearranged LAIV strains used in the immunogenic compositions disclosed in Table 1 in any combination, the L...

Embodiment 2

[0246] Embodiment 2: LAIV virus manufacturing process based on MDCK cells

[0247] A method of preparing an MDCK cell culture-based LAIV composition may comprise any subset or all of the following steps:

[0248] k) Passage of LAIV candidate vaccine virus initially in SPF chicken embryos producing egg-based master seed virus (MSV).

[0249] 1) Egg-based master seed virus was grown on MDCK cell culture (ATCC CCL-34) hosts to make cell-based working seed virus (WSV). This cell-based WSV is used in different cell culture vessels / systems (e.g. with a surface area of ​​175 cm 2 tissue culture flasks (TCFs) with a surface area of ​​850 cm 2 roller bottles (RBs) with a surface area of ​​6320cm 2 Cell factories (CFs) and fixed-bed bioreactors (e.g., from Life Sciences Inc. (Port Washington, New York) Infect MDCK cell cultures at an MOI of 1:100 to 1:10000 in bioreactors such as Nano bioreactor and 500 / 100 bioreactor)). (MDCK cells were cultured in MEM containing FBS; rinsed wi...

Embodiment 3

[0270] Example 3: Effect of virus input (MOI) and post-inoculation incubation period on yield

[0271]

[0272]

[0273] Infect:

[0274] A. Infection time:

[0275] Based on optimization studies, the upper limit of the number of cells infected with MDCK cell-derived influenza working seed virus was selected to be 120 to 180 million cells per roller bottle and 7 to 10 billion cells per bioreactor system. Microscopic observation of monolayer confluence was performed on roller bottles with MDCK cells prior to the infection procedure.

[0276] B. MOI and post-inoculation incubation period:

[0277] Based on all observations from MOI optimization studies, MOIs for influenza A(H1N1), A(H3N2) and B viruses were chosen to range from 1:100 to 1:10000, and post-inoculation incubation periods were between 48 and 72 hours between.

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Abstract

The present disclosure provides compositions and methods for manufacturing and obtaining a live attenuated Influenza vaccine (LAIV) composition that can be delivered intranasally to provide protection against influenza virus infection. Said LAIV strains are based on cold adapted, temperature sensitive and attenuated phenotypes of master donor viruses (MDVs) containing the surface glycoprotein genes of the wild type pandemic or seasonal influenza strains. Also, said LAIV strains are further adapted to grow in MDCK cells (Madin Darby canine kidney cells). The use of eggs is avoided in large scale vaccine manufacturing. The purification process is devoid of chromatography steps. The said LAIV composition includes one or more live attenuated influenza vaccine virus and is devoid of polymers and surfactants.

Description

technical field [0001] The present disclosure relates to the field of viral vaccine manufacture, and more specifically, to live attenuated influenza vaccine compositions and methods of making the same. The present disclosure relates to methods for producing viruses or viral antigens produced by cell culture, viruses or viral antigens obtained by such methods, and vaccines comprising such viruses or viral antigens. Background technique [0002] The background information herein below is related to the present disclosure but is not necessarily prior art. [0003] Epidemics and pandemics caused by infectious pathogens have occurred for centuries, causing major disruption and varying rates of morbidity and mortality. Influenza viruses have been one of the major players in the history of pandemics. Four influenza pandemics have occurred in the last century, and at least 15 have been documented to date, killing an estimated 50 million people in 1918-19 alone. [0004] Vaccines ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61P31/16A61K47/18A61K47/26A61K39/12A61K39/145
CPCA61K47/26C12N2760/16034A61K2039/5254A61K47/183A61P31/16A61K39/12A61K39/145A61K9/0019A61K47/42A61K47/02A61K47/22
Inventor 拉耶夫·姆哈尔萨坎特·德雷莱纳·拉温德拉·耶了卡米兰·肖梅纳特·甘古利帕里克西特·达拉姆帕尔·佳金优曼许·戈拉克·萨加尔斯瓦普尼尔·普拉巴卡尔·纳拉莱亚绍丹·迪利普·阿纳施普雷沙姆·拉姆达斯·图佩
Owner SERUM INST OF INDIA PTE LTD
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