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Stable rabies virus humanized antibody combined reagent

A human antibody, rabies virus technology, applied in the direction of antiviral agents, antibodies, etc., can solve problems such as difficulties and achieve the effect of convenient use

Active Publication Date: 2014-01-15
NCPC NEW DRUG RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Obviously, it is more difficult to find suitable excipients and optimal conditions for the long-term stability of two different mAbs at the same time

Method used

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  • Stable rabies virus humanized antibody combined reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 Preparation of NM57 and NC08 antibody combination preparation.

[0030] The liquid preparations of different antibody combination preparations were prepared according to the formulas in Table 1, and the solvent was pure water for injection to obtain semi-finished products.

[0031] Table 1. Formulas of different antibody combination preparations

[0032]

[0033] The semi-finished product is aseptically divided into vials, and the rubber stopper and aluminum-plastic cap are added to obtain the finished product.

Embodiment 2

[0034] Example 2 The 10 groups of samples numbered 1 to 10 prepared in Example 1 were stored according to the storage conditions in Table 2, and the neutralizing activity of the anti-rabies virus antibody in the solution preparation was regularly measured by rapid fluorescence focus inhibition test (RFFIT) , the product before preservation is used as a contrast, and the percentage value of the activity of the product after preservation and the activity of the product before preservation is defined as the activity of the product after preservation.

[0035] Table 2. Sample activity preserved under different conditions

[0036] Storage Conditions 0 weeks 1 week 　 　 　 　 1 37℃ 100%　 105%　 　 　 　 　 2 37℃ 100%　 96%　 　 　 　 　 3 37℃ 100%　 110%　 　 　 　 　 4 37℃ 100%　 95% 　 　 　 　 5 37℃ 100%　 95%　 　 　 　 　 6 37℃ 100%　 93%　 　 　 　 　 7 37℃ 100%　 　98% 　 　 　 　 8 37℃ 100%　 　100% 　 　 　 　 9 ...

Embodiment 3

[0038] Example 3 The 10 groups of samples numbered 1 to 10 prepared in Example 1 were stored according to the storage conditions in Table 2, and were regularly analyzed by molecular sieve high-pressure liquid chromatography (SEC-HPLC, TSK G3000 SW XL 7.8mmI.D.x30cm) to detect the purity of the antibody in the solution preparation, and investigate the stability of the antibody NM57 and NC08 in the preparation.

[0039] Stability testing method:

[0040] Instrument: Waters HPLC system (photodiode array detector)

[0041] Column: TSK G3000 SW XL 7.8mmI.D.x30cm

[0042] Mobile phase: 200mmol / L PB, 1% isopropanol, pH7.0

[0043] Flow rate: 0.5ml / min

[0044] Loading amount: 100μg

[0045] Detection wavelength: 280nm

[0046] Table 3. Stability of samples preserved under different conditions

[0047] Example Storage Conditions 0 weeks 1 week 　 　 　 　 1 37℃ 100%　 99.7% 　 　 　 　 2 37℃ 99.9%　 99.7% 　 　 　 　 3 37℃ 100%　 99.5% 　 　 ...

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Abstract

The invention discloses a stable rabies virus humanized antibody combined reagent. The stable rabies virus humanized antibody combined reagent is composed of recombined humanized rabies virus antibodies NC08 and NM57, a buffering agent, a surfactant, an isoosmotic adjusting agent and an antioxidant, and the pH value is 5.5 to 6.5. The stable rabies virus humanized antibody combined reagent is capable of maintaining the stability of the two antibodies for a long term, is high in solubility, is convenient for utilization, and can be used for post-exposure prophylaxis of rabies.

Description

technical field [0001] The invention belongs to the field of biotechnology, and more specifically, the invention discloses a biological preparation. Background technique [0002] Rabies is an acute progressive encephalitis caused by infection with RNA viruses of the Rhabdoviridae family (lyssavirus). Generally, dogs are the primary hosts for the disease, but other mammals such as raccoons, skunks, bats, and foxes are also common hosts. Transmission of the virus from animal hosts to humans usually occurs through skin bites or scratches. Since rabies is almost always fatal in humans, suspected infection must also be treated with an aggressive post-exposure treatment regimen. [0003] For severely exposed persons, the World Health Organization (WHO) recommends a combination of rabies vaccination with rabies immune globulin (RIG). The two types of RIG currently in use are human rabies immune globulin (HRIG) and equine rabies immune globulin (ERIG). Because ERIG is a heterolo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/42A61P31/14
Inventor 魏敬双王辉孔令锋程立均赵伟吕若芸刘祥义张世雄王茶江一帆高健段宝玲
Owner NCPC NEW DRUG RES & DEV
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