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Anti-rabies monoclonal antibodies and cocktail thereof

A technology of monoclonal antibody and cloning antibody, which is applied in the direction of antibodies, antiviral agents, antibody medical components, etc., and can solve problems such as the inability to provide high anti-rabies virus protection

Pending Publication Date: 2021-08-06
CADILA HEALTHCARE LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such antibodies may not be given early in high doses to provide high protection against rabies virus for the reasons discussed above in this paper in relation to human-derived RIG

Method used

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  • Anti-rabies monoclonal antibodies and cocktail thereof
  • Anti-rabies monoclonal antibodies and cocktail thereof
  • Anti-rabies monoclonal antibodies and cocktail thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0192] Example 1: Manufacture of Monoclonal Antibody mAbA Active Drug Substance

[0193] The drug substance manufacturing process for mAbA monoclonal antibodies involves—

[0194] - Upstream Sp2 / 0 cell culture process, and

[0195] - Downstream purification process.

[0196] produce mAb A Upstream culture process of monoclonal antibody

[0197]mAb A monoclonal antibody is produced by the host cells of the expression system during the culture of Sp2 / 0 cells in the presence of animal origin-free medium and feeder components. Media containing serum components can also be used to raise the antibodies. Each batch production upstream begins with resuscitation of the contents of a master cell bank (MCB) or working cell bank (WCB) vial of Sp2 / 0 cells bearing the mAb A polynucleotide sequence. Following resuscitation of the cell bank vials, a series of inoculum development steps were performed to generate a final inoculum with sufficient numbers of cells to inoculate into produ...

Embodiment 2

[0208] Example 2: Manufacture of mAb B Monoclonal Antibody Active Drug Substance

[0209] The drug substance manufacturing process for mAb B monoclonal antibody involves—

[0210] - Upstream Sp2 / 0 cell culture process, and

[0211] - Downstream purification process.

[0212] Upstream culture process for production of mAb B monoclonal antibody

[0213] mAb B monoclonal antibody is produced during cell culture by host cells expressing the system Sp2 / 0 in the presence of animal origin-free medium and feed components. Media containing serum components can also be used to raise the antibodies. Each batch production upstream begins with recovery of the contents of a master cell bank (MCB) or working cell bank (WCB) vial of Sp2 / 0 cells bearing the mAb B polynucleotide sequence. Following resuscitation of the cell bank vials, a series of inoculum development steps were performed to generate a final inoculum with sufficient numbers of cells to inoculate into production bioreactor...

Embodiment 3

[0225] Example 3: Preparation of Antibody Mixtures Comprising Equivalent Antibodies

[0226] The purified drug substances of mAb A and mAb B were assigned potency values ​​in IU / mg by performing the RFFIT test in order to prepare antibody mixtures containing equivalent amounts of both antibodies. The individual drug substances mAb A and mAb B were diluted on a concentration (mg / mL) basis by pH 6.0 citrate buffer containing sodium chloride and polysorbate to achieve similar potency values ​​in IU / mL. To prepare antibody mixtures comprising equivalent antibodies, both the diluted drug substances of mAb A and mAb B are mixed appropriately.

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PUM

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Abstract

The disclosure provides a murine monoclonal antibody capable of binding and neutralizing rabies or rabies related viruses. It also provides a cocktail of at least two monoclonal antibodies with said properties. The cocktail can neutralize the virus that is derived from species such as bats, dogs, cows, mongooses, skunks, and wolves, and thus can be useful in treating a patient that has potentially been infected. Further, the disclosure provides a combination of muring monoclonal antibody or cocktail of at least two monoclonal antibodies and anti-rabies vaccine for use in post-exposure prophylaxis (PEP) with rabies or rabies-related viruses.

Description

technical field [0001] The present invention relates to monoclonal antibodies capable of binding and neutralizing rabies or rabies-associated virus. More particularly, the invention relates to a cocktail of at least two monoclonal antibodies capable of binding and neutralizing rabies or rabies-associated virus. Background technique [0002] Rabies is a zoonotic disease caused by rabies virus (RABV), a type member of the genus Lyssavirus genus, and is responsible for >55 000 deaths per year (mostly in developing countries, where transmission is usually Occurs after a bite from an infected dog). Without treatment, the virus gradually infects surrounding neurons and spreads through the central nervous system, which almost always results in death. The disease can be prevented by post-exposure prophylaxis (PEP), which consists of administration of an inactivated RABV vaccine along with passive antibody therapy. In standard passive antibody therapy, polyclonal rabies immunog...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/42A61P31/14C07K16/10A61K39/00
CPCC07K16/10A61K39/42A61P31/14A61K2039/505A61K2039/507C07K2317/21C07K2317/33C07K2317/34C07K2317/76C07K2317/92
Inventor 桑吉夫·库马尔·门迪拉塔桑贾伊·班迪奥帕迪亚伊潘卡伊·卡利塔凯文库马尔·坎萨格拉
Owner CADILA HEALTHCARE LTD