Bulk Of Rabies Vaccine For Human Use->aspalthic products

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Changchun Changsheng Life Sciences Ltd.

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Bulk Of Rabies Vaccine For Human Use

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Chemicals->Chemical->aspalthic products

Product Specification

Model No:	L

Country	CN
Payment Term	L/C,T/T

Product Detail

Ready to fill bulk


[Standard for implementation] 
Pharmacopoeia of the People's Republic of China Vol. 3, 2015 and the official standard of this product registration. 
[Manufacturing]


2. 1  Cell substrates for vaccine production  
Vero cells shall be used for the vaccine production 
2. 1. 1   Management and  control  tests  on  cell substrates. 
It complies with the Requirements for Preparation and Control of Animals Cell Substrates Used for Production of Biologics. The maximum passage number of the cells from cell banks at every level shall not exceed the approved limit. 
2. 1. 2  Cell substrate preparation 
The cells from one or more containers of the working cell bank are resurrected to expand by serial 
subculture up to a quantity enough for making one lot of vaccine. The quantity of the cells can be 
defined as a cell batch. During the subculture of the cells, trypsin or other suitable digestion solution at an appropriate concentration is added onto the monolayer cell cultures to disperse cells. The dispersed cells are suspended evenly with suitable growth medium and distributed into culture bottles. Incubate the cells at 370C to form confluent monolayers. 
2. 2   Virus seeds 
2. 2. 1   Name and origin of virus strains 
Rabies fixed virus CTN-1V strain and aGV strain or other approved Vero cell-adapted rabies fixed 
virus strain can be used as the seed for the vaccine production. 
2. 2. 2   Establishment of virus seed lot system 
It complies with the Requirements for Bacterial and Viral Strains/Seeds Used for Manufacture and Quality Control of Biologics. The passage number of every seed lot shall not exceed the approved limit. The subculture of CTN-1V strain in Vero cells to establish the working virus seed lot shall not exceed 35 passages. The subculture of aGV strain in Vero cells to establish the working virus seed lot shall not exceed 15 passages. 
2. 2. 3  Control tests on 
The master seed lot virus seed lots shall be subjected to comprehensive control tests described below and the working seed lot shall be subjected to the tests described in Sections 2.2.3.1-2.2.3.4 at least. 
2. 2. 3. 1  Identity test 
Intracerebral neutralization  test  in  mice  is employed to identify the specificity of the virus 
seed. The virus seed lot is 10-fold serially diluted. The virus suspensions at appropriate dilutions are mixed respectively with an equal volume of the rabies virus specific immune serum as the test group and with an equal volume of the rabies virus negative serum as the control group. Inoculate i.c.  each mouse weighing 11-13 g with 0. 03 ml of each dilution of the test group and with that of the control group, respectively. Six mice are inoculated for each dilution.  Observe the test mice daily for 14 days. The mice that die within 3 days after inoculation shall be excluded in the final evaluation of the test and for the test to be valid, not more than 20 % of total test mice shall die. The neutralization index shall be not less than 500. 
2. 2. 3. 2   Virus titration 
Dilute the virus seed 10-fold serially.  Take 0.03ml respectively from the suitable dilutions to inoculate i. c. individual six mice each weighing 11-13g for each dilution. The mice that die within 3 days after inoculation shall be not included in the final evaluation of the test, and for the test to be valid, not more than 20 % of total test mice shall die. Observe the test mice daily for 14 days.  The titer of the virus shall be not less than 7.5 lg LD50/ml. 
2. 2. 3. 3   Sterility test 
It complies with the test for sterility (Appendix XII A) . 
2. 2. 3. 4   Tests for mycoplasmas 
It complies with the test for mycoplasmas (Appendix XII B). 
2. 2. 3. 5   Tests for adventitious viruses 
It complies with the tests for adventitious viruses (Appendix XII C). 
2. 2. 3. 6   Test for immunogenicity 
Prepare the original vaccine with the master seed virus to immunize i. p. mice each weighing 12-14 g. Each mouse receives 0. 5 ml twice at an interval of 7 days as the test group. The unimmunized mice of the same batch shall be served in parallel as the control group. On the 14th day after the first inoculation, challenge i. c. the immunized and unimmunized mice individually with 0.03 ml of each dilution of the 10-fold serially diluted rabies challenging virus CVS strain. Ten mice are challenged with each dilution of the challenging virus. The mice that die within 3 days after inoculation shall not be included in the final evaluation of the test, and for the test to be valid,not more than 20 % of total test mice shall die. Observe the test mice daily for 14 days and evaluate the result at the the protective index shall end of observation, and be more than 100. 
2. 2. 4  Storage of virus seed lots 
Store at or below -60℃. 
2.3  Bulk 
2. 3. 1  Cell substrate preparation 
See Section 2. 1. 2. 
2. 3. 2   Culture medium 
MEM and medium199, containing a quantity of inactivated new-born calf serum or other suitable medium can be used for culture medium. The quality of new-born calf serum shall comply with the related requirements (Appendix XIII D).                     
2. 3. 3   Tests for adventitious viruses in control cells 
 It complies with the tests for adventitious viruses (Appendix XII C). 
2. 3. 4  Virus inoculation and cultivation 
The cell cultures with confluent monolayer are selected. Inoculate rabies virus seed at 0.01-0.1MOI onto the confluent monolayer of cell cultures (with the same MOI for the same virus working seed lot). Incubate the cell cultures at an appropriate temperature for a period of time.  And then discard the culture medium and wash the monolayers thoroughly with sterile PBS or other appropriate rinsing solution to remove calf serum.Then a quantity of maintenance medium is added to continue  the  cultivation  process  at  33-35℃. 
2. 3. 5  Virus harvest 
After incubation for a period of time, the virus suspension can be harvested. Multiple harvests can be carried out after further cultivation with replacing maintenance medium if the quality of cells is good enough. After being qualified in control tests, the virus suspensions harvested at the same time from the same cell batch can be pooled and defined as a single virus harvest. 
2. 3. 6  Control tests on single virus harvests 
See Section 3. 1. 
2. 3. 7   Storage of single virus harvests 
Store at 2-8℃ for not more than 30 days. 
2. 3. 8. Pooling and concentration 
After being qualified in control tests, the several single virus harvests derived from the same cell batch can be pooled, which can be concentrated through ultrafiltration or other appropriate method to the prescribed range of protein content. 
2. 3. 9  Virus inactivation 
After being concentrated, the single virus harvests shall be inactivated by adding ß-propiolactone in a proportion of 1:4000 at an appropriate temperature for a period of time. The inactivated virus suspension shall be kept at an appropriate temperature for a period of time to make ß-propiolactone hydrolyzed totally. A sample shall be taken immediately from each virus inactivation container at the end of inactivation process for the respective validation of inactivation. 
2. 3. 10  Purification 
The inactivated virus suspension shall be purified by means of chromatography or other appropriate methods. The bulk is prepared after the addition of an amount of human albumin or other appropriate stabilizer. 
2. 3. 11  Control tests on bulk 
See Section 3. 2. 
2. 4  Final bulk 
2. 4. 1  Formulation 
The bulk shall be formulated based on the prescribed protein and antigen content so as to make the total protein content to be not more than 80 µg per single human dose, and the final bulk is made after adding appropriate stabilizer. 
2. 4. 2  Control tests on final bulk 
See Section 3. 3. 
2. 5  Final product 
2. 5. 1   Defining batches 
It complies with the Requirements for Defining Batches of Biologics. 
2. 5. 2  Filling and lyophilization 
It complies with the Requirements for Filling and Lyophilization of Biologics. 
2. 5. 3  Specifications 
o.5 ml or l.0 ml of reconstituted vaccine per container as the stated value. 0. 5 ml or l. 0 ml per single human dose each time. The potency of rabies vaccine shall be not less than 2. 5 IU. 
2. 5. 4  Packaging 
It complies with the Requirements for Packaging of Biologics. 
3  Control tests 
3. 1   Control tests on single virus harvests 
3. 1. 1  Virus titration 
See Section 2. 2. 3. 2.  It shall be not less than 6.0 lg LD50/ml. 
3. 1. 2  Sterility test 
It complies with the test for sterility (Appendix XII A). 
3. 1. 3  Tests for mycoplasmas 
It complies with the test for mycoplasmas (Appendix XII B) . 
3. 2  Control tests on bulk 
3. 2. 1  Sterility test 
It complies with the test for sterility (Appendix XII A) 
3. 2. 2  Validation test for effective inactivation 
An amount of 25 ml of the inactivated virus suspension is inoculated onto Vero cell sheets. Each 1 ml of the inactivated virus suspension shall be inoculated onto an area of 3 cm2 monolayer cell sheet. After adsorption for 60 min at 37℃, the cell culture medium shall be added, and the quantitative proportion of the culture medium to the virus suspension shall be not more than 1 : 3. Subculture shall be carried out once every 7 days. Harvest the culture medium after 2ldays' incubation. Mix the harvested mediums, and inoculate i. c. each of 20 mice weighing 11-13 g with the mixed mediums. Each mouse receives 0.03 ml. The mice that die within 3 days after inoculation shall be not be included in the final evaluation of the test, and for the test to be valid, not more than 20 % of total test mice shall die. Observe the test animals for 14 days. All of them shall survive the observation period. 
3. 2. 3  Protein content 
The test sample shall be taken from the purified preparation prior to the addition of human albumin. The protein content shall be not more than 80 µg/dose (Appendix VI B, method 2). 
3.2.4   Antigen content 
The antigen content can be determined by ELISA. The approved standard of antigen content shall apply. 
 



[Eligibles]


If a person is bitten or scratched by a rabid dog or other rabid animals, regardless of age or sex, the wounds shall be cleaned immediately (flush the wounds repeatedly with clean water or soup water, followed by applying iodine tincture or ethanol for several times), and the exposed person shall be inoculated with the vaccine according to the post-exposure schedule as soon as possible. The person at risk of contacting rabies virus (such as veterinarians, animal breeders, forestry workers, workers in slaughterhouse and staffs in rabies laboratory) shall be immunized following the pre-exposure treatment schedule.


[Function and use]


The preparation can induce immunity against rabies virus in recipients following immunization. It is used to prevent rabies in human.

 
 

 


 
 



 
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