Concept of immunity and vaccine production

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People will be able to understand about immunology and vaccine products preparation.

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Concept of immunity and vaccine production Prepared By: Dr. Jaydeep Patel, Lecturer, B.K.Mody Govt. Pharmacy college, Rajkot-360003. :

Concept of immunity and vaccine production Prepared By: Dr. Jaydeep Patel, Lecturer, B.K.Mody Govt. Pharmacy college, Rajkot-360003.

Immunoloy:

Immunoloy

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Infection:

Infection Physical contact with a diseased person or animal Droplet infection Dust borne infection Contact with contaminated articles Hand infection Arthropod vectors

Factor influencing Infection:

Factor influencing Infection

Defence mechanism of body:

Defence mechanism of body Primary Defense mechanism Secondary Defense mechanism

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Types Of Immunity

Immunity:

Immunity

Active immunity- developed and lost slowly :

Active immunity- developed and lost slowly Toxoids Suspension of micro organism

Passive immunity- produced and lost quickely:

Passive immunity- produced and lost quickely Anti toxic antibody Antibacterial antibody Antiviral antibody

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Antigen containing preparations Antibody containing preparations Stimulates active immunity Patient produces antibody Immunity develops slowly Lasting effect Used for long term prophylaxis Give passive immunity Patient receives antibodies Immunity produced quickly Temporary effect Used for short term prophylaxis and therapeutically

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Types of vaccines

Vaccines:

Vaccines Toxoids Diphtheria Tetanus staphylococcus Suspensions of micro organism Bacterial Rickettsial Viral

Bacterial vaccines:

Bacterial vaccines Attenuated Bacillus Calmette -Guerin(BCG) Killed Cholera Pertussis Plague Typhoid-paratyphoid A and B (TAB) Typhoid-paratyphoid A,B and C (TABC)

Viral Vaccines:

Viral Vaccines Attenuated Measles Poliomyelitis Yellow fever Small pox Killed Influenza Measles Poliomyelitis Rabies

Rickettsial:

Rickettsial Killed Typhus

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Production Of Vaccines

General requirements for vaccines:

General requirements for vaccines Production In process testing produced using a seed-lot system maintain adequate immunogenic properties render the preparation harmless prevent contamination with extraneous agents. production of a final lot of vaccine, the number of passages of a virus, or the number of subcultures of a bacterium, from the master seed lot shall not exceed

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Substrates for propagation Seed lot Culture media Propagation and harvest Control cells Control eggs Purification Inactivation Intermediates Final bulk Adsorbents

Vaccines: Substrates for propagation:

Vaccines: Substrates for propagation comply with the relevant requirements of the Pharmacopoeia Processing of cell banks and subsequent cell cultures is done under aseptic conditions in an area where no other cells are being handled Serum and trypsin used in the preparation of cell suspensions shall be shown to be free from extraneous agents.

Vaccines: Seed lot:

Vaccines: Seed lot The strain of bacterium or virus used in a master seed lot is identified by historical records No micro-organism other than the seed strain shall be present in a seed lot.

Vaccines: Culture media:

Vaccines: Culture media free from ingredients known to cause toxic, allergic or other undesirable reactions in man If any inclusion then amount present in the final lot is reduced to such a level as to render the product safe Approved animal (but not human) serum may be used in the growth medium but the medium used for maintaining cell growth during virus multiplication shall not contain serum pH indicator such as phenol red and approved antibiotics at the lowest effective concentration

Vaccines: Propagation and harvest:

Vaccines: Propagation and harvest The seed cultures are propagated and harvested under defined conditions. The purity of the harvest is verified by suitable tests as defined in the monograph.

Vaccines: Control cells:

Vaccines: Control cells For vaccines produced in cell cultures, control cells are maintained and tested as prescribed. In order to provide a valid control, these cells must be maintained in conditions that are rigorously identical with those used for the production cell cultures, including use of the same batches of media and media changes.

Vaccines: Control eggs:

Vaccines: Control eggs For live vaccines produced in eggs, control eggs are incubated and tested as prescribed in the monograph

Vaccines: Purification.:

Vaccines: Purification . Where applicable, validated purification procedures may be applied.  

Vaccines: Inactivation.:

Vaccines: Inactivation . validated inactivation process whose effectiveness and consistency have been demonstrated Where there are recognized potential contaminants of a harvest, for example in vaccines produced in eggs from healthy, non-SPF flocks, the inactivation process is also validated with respect to the potential contaminants . A test for inactivation is carried out as soon as possible after the inactivation process, unless otherwise justified and authorized

Vaccines: Intermediates:

Vaccines: Intermediates Where applicable, the stability of intermediates in given storage conditions shall be evaluated and a period of validity established.

Vaccines: Final bulk:

Vaccines: Final bulk The final bulk is prepared by aseptically blending the ingredients of the vaccine

Vaccines: Adsorbents:

Vaccines: Adsorbents Vaccines may be adsorbed on aluminum hydroxide, aluminum phosphate, calcium phosphate or other suitable adsorbent; the adsorbents are prepared in special conditions which confer the appropriate physical form and adsorptive properties.

Vaccines: Antimicrobial preservative:

Vaccines: Antimicrobial preservative In sterile and inactivated vaccines and is invariably added if these preparations are issued in multidose containers It shall be shown that it does not impair the safety or efficacy of the vaccine and its effectiveness throughout the period of validity shall be demonstrated.

Vaccines: Final lot:

Vaccines: Final lot For parenteral administration prepared by aseptically distributing the final bulk into sterile tamper-proof containers which, after freeze-drying where applicable, are closed Non- parenteral route prepared by distributing the final bulk under suitable conditions into sterile, tamper-proof containers

Vaccines: Stability:

Vaccines: Stability Maintenance of potency of the final lot throughout the period of validity shall be demonstrated by validation studies

Vaccines: Degree of adsorption:

Vaccines: Degree of adsorption Evaluated as part of the consistency testing. A release specification for the degree of adsorption is established in the light of results found for batches used in clinical testing. From the stability data generated for the vaccine it must be shown that at the end of the period of validity the degree of adsorption will not be less than for batches used in clinical testing

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Tests

Phenol in vaccines and antisera:

Phenol in vaccines and antisera If present then Not more than 0.25 per cent w/v. Dilute an appropriate volume with water to give a solution containing about 15 µg of phenol per ml. To 5.0 ml of the resulting solution add 5 ml each of buffer solution pH 9.0, 4-aminophenazone solution and potassium ferricyanide solution. Allow to stand for 10 minutes and measure the absorbance of the resulting solution at about 546 nm and calculate the phenol content.

Thiomersal in vaccines and antisera:

Thiomersal in vaccines and antisera If present then Between 0.005 per cent w/v and 0.02 per cent w/v. Take 0.1ml of the preparation under examination containing about 50 µg per ml of thiomersal in a test-tube add sufficient distilled water to produce 1.0 ml. To this solution add 1.0 ml of acetone, 1.0 ml of a freshly prepared 0.0001 per cent w/v solution of dithizone in acetone and 0.1ml of sodium hydroxide (50 per cent w/v). Measure the absorbance of the resulting solution at 558 nm and calculate

Free formaldehyde in vaccines:

Free formaldehyde in vaccines If present then Maximum 0.02 g/l Use Method A unless otherwise specified. Method A To 1.0 ml of a ten-fold dilution of the preparation under examination in a test-tube add 4.0 ml of water and 5.0 ml of acetylacetone reagent. Warm in a water-bath at 40º and allow to stand for 40 minutes. The solution is not more intensely coloured than a reference solution prepared at the same time and in the same manner using 1.0 ml of a solution containing 0.002 per cent w/v of formaldehyde in place of the dilution of the preparation. The comparison should be made examining the tubes down their vertical axes.

Free formaldehyde in vaccines cont…:

Free formaldehyde in vaccines cont… Method B To 1.0 ml of ten-fold dilution of the preparation under examination in a test-tube add 2.0 ml of water, 1.0 ml of a 1 per cent w/v solution of phenylhydrazine hydrochloride, 0.5 ml of a 5 per cent w/v solution of potassium ferricyanide and 1.0 ml of hydrochloric acid and allow to stand for 15 minutes. The solution is not more intensely coloured than a reference solution prepared at the same time and in the same manner using 1.0 ml of a solution containing 0.002 per cent w/v of formaldehyde in place of the dilution of the preparation. The comparison should be made examining the tubes down their vertical axes.

Aluminium in absorbed vaccines:

Aluminium in absorbed vaccines Not more than 1.25 mg per dose. 5 mg of aluminium to a 50-ml combustion flask. Add 1 ml of sulphuric acid, 0.1 ml of nitric acid . Heat the solution until thick, white fumes are evolved. Allow to cool, add 0.05 ml of methyl orange solution and neutralise with 10M sodium hydroxide. Add 25.0 ml of 0.002 M disodium edetate , 10ml of buffer solution pH 4.4 and boil gently for 3 minutes. Add 0.1 ml of pyridylazonaphthol solution and titrate the excess of disodium edetate in the hot solution with 0.02 M cupric sulphate until the colour changes to purplish brown. Repeat the operation omitting the substance under examination.

Sterility:

Sterility Unless otherwise stated all vaccines comply with tests for sterility, except that for living bacterial vaccines, growth of the organism from which the vaccine was prepared is permitted

Abnormal toxicity:

Abnormal toxicity Carry out the test also on two healthy guinea-pigs weighing 250 g to 350 g. Inject intraperitoneally into each animal one human dose but not more than 5.0 ml. Observe the animals for 7 days. The preparation passes the test if none of the animals shows signs of ill-health. If more than one animal dies, the preparation fails the test. If one of the animals dies or shows signs of ill health, repeat the test. The preparation passes the test if none of the animals in the second group die or show signs of ill health in the time interval specified.

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storage

Storage for vaccines:

Storage for vaccines Liquid vaccines must be stored at a temperature between 2 o and 8 o and should not be allowed to freeze unless otherwise specified in the individual monograph. Freeze-dried preparations must be stored at temperatures below –20 o or as specified in the individual monograph. At higher temperatures vaccines deteriorate rapidly.

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Labelling

Labelling for vaccines:

Labelling for vaccines The label states (1) for liquid vaccines, the total number of ml in the container and, for dried vaccines, the number of doses in the container; (2) unless otherwise indicated the minimum number of Units per dose or per ml or, for viral vaccines, the minimum viral titre ; (3) the dose and route of administration; (4) the name and proportion of any antibacterial preservative or other auxiliary substances added to the vaccine; (5) the date after which the vaccine is not intended to be used; (6) the conditions under which it should be stored; (7) for dried vaccines, the liquid to be used for reconstitution and its volume; (8) that the vaccine should be used immediately after reconstitution; (9) unless otherwise directed, that the vaccine should be shaken well before use; (10) any contraindication to the use of the vaccine.

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