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Recombinant adenovirus lyophilized preparation and preparing method thereof

A technology for recombinant adenovirus and freeze-dried preparations, which is applied in the field of recombinant adenovirus freeze-dried preparations and preparations, to achieve the effects of long validity period, good safety and stability, and good stability

Active Publication Date: 2009-04-08
SHANGHAI SUNWAY BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved by the present invention is to solve the stability of existing recombinant adenovirus preparations, and provide a safe, efficient, stable and long-term freeze-dried recombinant adenovirus preparation

Method used

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  • Recombinant adenovirus lyophilized preparation and preparing method thereof
  • Recombinant adenovirus lyophilized preparation and preparing method thereof
  • Recombinant adenovirus lyophilized preparation and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] The recombinant adenovirus preparation containing the lyoprotectant was prepared according to the amount of adenovirus contained in it at 0.5×10 12 The concentration of the number of particles / ml is divided into 1ml / bottles, and a part of the preparation is stored at 4°C with a stopper and a cap for the detection of the infectious titer before the preparation is freeze-dried. Freeze dried. 3 different batches of recombinant adenovirus preparations containing lyoprotectants were freeze-dried, and the infectious titer test proved that: the freeze-dried recombinant adenovirus preparations made by the method of the present invention had higher infectious titers than frozen preparations after freeze-drying. Only drop in 0.03-0.05logTCID before drying 50 / ml between. (Table 1)

[0021] Table 1: Infectious titer determination of recombinant adenovirus preparations before and after freeze-drying

[0022]

Embodiment 2

[0024] The same batch of recombinant glandular glands containing sucrose, mannitol, gelatin, L-cysteine, trehalose, potassium chloride, potassium dihydrogen phosphate, basic amino acid medium (Dulbecco's Modified Eagle Medium, D-MEM for short) balanced salt The virus freeze-dried preparation and the liquid control preparation without freeze-drying were stored in the same 4-8°C refrigerator, and the infectivity titer of the preparation was measured by random random sampling. The results proved that: the freeze-dried recombinant adenovirus prepared by the method of the present invention The preparation has good stability. When stored at 4-8°C for 30 months, the infectious titer of the preparation drops to 0.5logTCID 50 / ml, and the liquid control preparation without freeze-drying was stored at 4-8°C for 30 months, and the infectious titer decreased significantly, reaching 3logTCID 50 / ml. This result proves that: the infectivity titer of the non-lyophilized liquid control prepa...

Embodiment 3

[0028] Lyoprotectant containing sucrose, mannitol, gelatin, L-cysteine, trehalose, potassium chloride, potassium dihydrogen phosphate and basic amino acid medium (Dulbecco's Modified Eagle Medium, referred to as D-MEM) balanced salt Recombinant adenovirus preparation and lyoprotectant and basic amino acid medium (Dulbecco's Modified Eagle Medium, referred to as D- MEM) balanced salt solution, and the recombinant adenovirus preparation diluted with PBS were freeze-dried under the same vacuum freeze-drying condition, and then randomly sampled to determine the infectious titer of the preparation. The results proved that the virus activity was basically lost after freeze-drying the preparation without protective agent. (table 3)

[0029] Table 3: Effects of lyoprotectants on infectivity titers of recombinant adenovirus lyophilized preparations

[0030]

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Abstract

The present invention relates to a recombinant adenovirus freeze-dried preparation and its preparation method. The recombinant adenovirus freeze-dried preparation disclosed by said invention is the preparation which is obtained after the aqueous solution prepared by using recombinant adenovirus: protective agent (volume ratio)=1:(0.8-1.2) is frozen and dried. The above-mentioned protective agent contains animal glue, sugar, inorganic salt and amino acid culture balanced salt whose pH value is 7.2-8.0. Said recombinant adenovirus freeze-dried preparation is safe, and high in effect and good in stability.

Description

Technical field: [0001] The invention belongs to the field of biological preparations and preparation, and in particular relates to a recombinant adenovirus freeze-dried preparation and a preparation method. Background technique: [0002] With the gradual deepening of gene therapy research, the research on viral vectors as its basis has developed by leaps and bounds. The gene transfer technology using viral vectors to treat human diseases is not only in laboratory research, but also has entered the stage of clinical trials. Adenovirus has become a research hotspot of viral vectors in recent years because of its low pathogenicity to humans, no induction of carcinogenesis, wide range of host cells, high reproductive titer, and large loading capacity. However, even liquid recombinant adenovirus preparations containing stabilizers are relatively sensitive to temperature, which brings great difficulties to transportation and storage, which largely limits their clinical applicati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/00A61K48/00A61K9/19
Inventor 顾菁童涌梁旻
Owner SHANGHAI SUNWAY BIOTECH
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