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Immunological products

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Pradeep Hk
Pradeep Hk

This document provides information on immunological products including definitions of key terms like antigen, antibody, and immunity. It discusses active and passive immunity and how vaccines and sera provide them. Vaccines contain live attenuated, killed, or inactivated microorganisms or toxins to induce immunity. Sera contain pre-formed antibodies obtained from immunized animals. The document describes various bacterial, viral, toxoid, and live attenuated vaccines and their methods of preparation and storage conditions. Overall, the document serves as an overview of immunological products like vaccines and sera, how they provide immunity, and basic information about their production and handling.

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Immunological Products Pradeep HK Asst. Professor Department of Pharmaceutics GM Institute of Pharmaceutical Sciences and Research Davangere www.pradeephkgmips.weebly.com
Terminologies Antigen Antibody Immunity Vaccines Sera
Immunity
Immunological products
Active Immunity Here immunity of the body system enhanced by increasing the production of antibodies by giving an antigens (vaccines). For examples Live attenuated vaccines: (rubella, measles, oral polio, mumps) or bacteria - bacillus Calmette-Guerin (BCG). Inactivated or Killed Vaccines (parenteral polio, hepatitis A) or parts of the bacterium or virus (pneumococcal vaccine, influenza). Inactivated bacterial toxins (diphtheria and tetanus). Genetically engineered (hepatitis B vaccine)
Passive Immunity
Immunological products
Immunological products
Immunological products
Active Immunity Passive Immunity Produced actively by the immune system of the host Produced passively by the immune system of host Antibodies production is induced by the infection or Immunogens Antibodies are not produced but directly transferred It involves cell mediated or humoral immunity No mediation as direct transfer of antibodies Natural active immunity is clinical infection Natural passive immunity is by transfer of antibodies through placenta Artificial active immunity induced by vaccination Artificial passive immunity is induced by injection of antibodies A lag period is present Lag period is absent It is active only after the lag period Active immediately after transfer of antibodies Active immunity is longer duration Short term Immunological memory is present Immunological memory absent On subsequent doses it have booster effect Subsequent doses is less effective It is not applicable for immune deficient individuals It is applicable for immune deficient individuals
Vaccines Vaccines are preparations of antigenic materials, which are administered with the objective of inducing in the recipient specific and active immunity against infectious microorganisms or toxins produced by them. They contain living or killed microorganisms, bacterial toxoids or antigenic material from the particular parts of bacteria, rickettsia, or virus
Classification Active Immunisation Live attenuated vaccines Inactivated or killed vaccines Toxoids Cellular fractions Combinations Passive Immunisation Immunoglobin Antisera
Bacterial Vaccines Viral Vaccines Live vaccines BCG vaccination. Typhoid vaccination (oral). Cholera vaccination (oral). Measles vaccination. Mumps vaccination. Rubella vaccination. Oral polio vaccination (Sabin). Yellow fever vaccination. Varicella (chickenpox) vaccination. Rotavirus vaccination. Japanese encephalitis vaccination. Inactivated vaccines Pertussis (whooping cough) vaccination. Cholera vaccination (oral, combined with recombinant B subunit). Anthrax vaccination. Plague vaccination. Meningitis B vaccine. Influenza vaccination. Hepatitis A vaccination. Injectable polio vaccination (Salk). Rabies vaccination. Tick-borne encephalitis vaccination. Japanese encephalitis vaccination. Toxoids Diphtheria vaccination. Tetanus vaccination. Polysaccharide extracts of virus Haemophilus influenzae type B (Hib) vaccination. Meningococcal A and C vaccination. Pneumococcal vaccination. Typhoid vaccination. Genetically engineered Hepatitis B vaccination.
Live attenuated Vaccines To produce a live vaccine, the wild or disease- causing virus is attenuated (weakened), traditionally by repeated culture in the laboratory, The virulence properties of the virus are reduced so that it does not cause disease in healthy individuals. The attenuated vaccine virus multiplies to a limited extent in host tissue and induces an immune response similar to wild virus infection in the majority of subjects. Live vaccines are generally very effective and induce long-lived immunity. Eg. Measles, Mumps, Rubella, Varicella, Rotavirus, Tuberculosis (BCG)
Killed and inactivated vaccines The term killed is generally used for bacterial vaccines and the term inactivated for viral vaccines. These vaccines are prepared by treating the whole cell or virus with chemicals that cause inactivation. Generally these organisms remain intact and whole. They generate an immune response (to a broad range of antigens) but cannot cause an infection because they are dead and so cannot reproduce. Eg. Hepatitis A, Some influenza vaccines
Toxoid vaccines In some bacterial infections (eg, diphtheria, tetanus), the clinical manifestations of disease are caused not by the bacteria themselves but by the toxins they secrete. Toxoid vaccines are produced by harvesting a toxin and altering it chemically (usually with formaldehyde) to convert the toxin to a toxoid. The toxoid is then purified. Toxoid vaccines induce antibodies that neutralise the harmful exotoxins released from these bacteria.
Sera Blood = Cells + Plasms Plasma = water + proteins + dissolved substances Serum = Plasma Clotting factors
The serum / sera is a portion of blood remaining after coagulation of the blood, during which process plasma protein fibrinogen is converted in to fibrin and remains behind the clot. Antiserum: antiserum is prepared from the blood of animals or humans that have been exposed to disease or infections and have developed specific antibodies, those antibodies were used to protect the persons against the disease. Ex: Hapatoglobin, its a colourless protein of a 留 globulin fraction of human serum
Preparation of Serum The blood is allowed to clot at room temperature for 15 to 30 minutes. When the blood has clotted completely, it is rimmed or ringed with an applicator stick. Then centrifuged for 5-10 minutes at 2,500 revolutions per minute (rpm). Finally the supernatant fluid is then separated making use of a Pasteur pipette, and labeled accordingly.
Differences between Vaccines and Sera Vaccines Sera Vaccines are preparations of antigenic materials, which are administered with the objective of inducing in the recipient specific and active immunity against infectious microorganisms or toxins produced by them. The clear, pale yellow liquid that separates from the clot in the coagulation of blood. Or Serum is a portion of blood remaining after coagulation of blood. Contain dead bacteria or weak bacteria or toxins Do not contain any bacteria or toxins Stimulates the body to make antibodies Acquired immune immediately Immunity remains for longer time Immunity remains for shorter time Obtained from series of complex process to get live or inactivated vaccines Specific animal by immunisation, whole blood is collected in, but the serum is non- specific mixture obtained after centrifugation. Normally it consists of single type of monoclonal antibodies or may be for a particular disease. It may contain monoclonal or polyclonal antibodies (antiserum)
Methods of Preparation
Immunological products
Immunological products
Preparations of Bacterial Vaccines Method Sterilised via low thermal or filtration Ex :Bacillus Calmette Guerin Vaccine (BCG, Tub, Vac) Cholera Vaccine (Vibrio Cholera vaccine) Pertussis Vaccine ( Whooping cough vaccine) Plague Vaccine Gen Storage options Store in dark between 2 to 8 属C B.C.G (Mycobacterium tuberculosis live) Liquid /dry Liquid form 14 days shelf life Dry form 12 months
Baceterial Toxoins
Bacterial toxoids Toxins Endo and exotoxins formaldehyde Toxin Toxoid Precipatation of Toxoid with Alum, flocculating it with corresponding antitoxin Or adsorbing on aluminium hydroxide or hydrated aluminium phosphate. Precipitate is washed and resuspended in isotonic solution with blood. Diphtheria vaccination. Tetanus vaccination
Viral or Rickettsial Vaccines Generally they are resistant to Treatment of antibiotic and chemotherapeutic agents Generally prepared from infected tissues, or from the animal, which have been deliberately infected with virus or rickettsiae. (rabies, small pox) Host (fertile Egg) / Cell cultures (poliomyelitis, small pox) Living (live attenuated strains) Non pathogenic Pathogenic - inactivation/ limitations of its activity by treating with formaldehyde or low thermal activity Note : Small pox is availalable in both dry and liquid form Yellow fever vaccine is available only in dry form and other vaccines available in liquid forms.
Storage Viral /rickettsial Vaccine Temperature Shelf Life Poliomyelitis Frozen State Two years 0 to 4属C Six months 18 to 20属C 7 days Liquid Small Pox -10 to -20属C 12 months 2 to 8属C Two weeks 10 to 20属C One week Dried Small pox 2 to 10属C Indefinitely At 29属C 1 year Yellow Fever Dry state 4属C 1 year Rabies 2 to 4属C Six months In general other viral or rickettsial vaccines stored between 2 to 8属C in dark place
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Immunological products

  • 1. Immunological Products Pradeep HK Asst. Professor Department of Pharmaceutics GM Institute of Pharmaceutical Sciences and Research Davangere www.pradeephkgmips.weebly.com
  • 2. Terminologies Antigen Antibody Immunity Vaccines Sera
  • 5. Active Immunity Here immunity of the body system enhanced by increasing the production of antibodies by giving an antigens (vaccines). For examples Live attenuated vaccines: (rubella, measles, oral polio, mumps) or bacteria - bacillus Calmette-Guerin (BCG). Inactivated or Killed Vaccines (parenteral polio, hepatitis A) or parts of the bacterium or virus (pneumococcal vaccine, influenza). Inactivated bacterial toxins (diphtheria and tetanus). Genetically engineered (hepatitis B vaccine)
  • 10. Active Immunity Passive Immunity Produced actively by the immune system of the host Produced passively by the immune system of host Antibodies production is induced by the infection or Immunogens Antibodies are not produced but directly transferred It involves cell mediated or humoral immunity No mediation as direct transfer of antibodies Natural active immunity is clinical infection Natural passive immunity is by transfer of antibodies through placenta Artificial active immunity induced by vaccination Artificial passive immunity is induced by injection of antibodies A lag period is present Lag period is absent It is active only after the lag period Active immediately after transfer of antibodies Active immunity is longer duration Short term Immunological memory is present Immunological memory absent On subsequent doses it have booster effect Subsequent doses is less effective It is not applicable for immune deficient individuals It is applicable for immune deficient individuals
  • 11. Vaccines Vaccines are preparations of antigenic materials, which are administered with the objective of inducing in the recipient specific and active immunity against infectious microorganisms or toxins produced by them. They contain living or killed microorganisms, bacterial toxoids or antigenic material from the particular parts of bacteria, rickettsia, or virus
  • 12. Classification Active Immunisation Live attenuated vaccines Inactivated or killed vaccines Toxoids Cellular fractions Combinations Passive Immunisation Immunoglobin Antisera
  • 13. Bacterial Vaccines Viral Vaccines Live vaccines BCG vaccination. Typhoid vaccination (oral). Cholera vaccination (oral). Measles vaccination. Mumps vaccination. Rubella vaccination. Oral polio vaccination (Sabin). Yellow fever vaccination. Varicella (chickenpox) vaccination. Rotavirus vaccination. Japanese encephalitis vaccination. Inactivated vaccines Pertussis (whooping cough) vaccination. Cholera vaccination (oral, combined with recombinant B subunit). Anthrax vaccination. Plague vaccination. Meningitis B vaccine. Influenza vaccination. Hepatitis A vaccination. Injectable polio vaccination (Salk). Rabies vaccination. Tick-borne encephalitis vaccination. Japanese encephalitis vaccination. Toxoids Diphtheria vaccination. Tetanus vaccination. Polysaccharide extracts of virus Haemophilus influenzae type B (Hib) vaccination. Meningococcal A and C vaccination. Pneumococcal vaccination. Typhoid vaccination. Genetically engineered Hepatitis B vaccination.
  • 14. Live attenuated Vaccines To produce a live vaccine, the wild or disease- causing virus is attenuated (weakened), traditionally by repeated culture in the laboratory, The virulence properties of the virus are reduced so that it does not cause disease in healthy individuals. The attenuated vaccine virus multiplies to a limited extent in host tissue and induces an immune response similar to wild virus infection in the majority of subjects. Live vaccines are generally very effective and induce long-lived immunity. Eg. Measles, Mumps, Rubella, Varicella, Rotavirus, Tuberculosis (BCG)
  • 15. Killed and inactivated vaccines The term killed is generally used for bacterial vaccines and the term inactivated for viral vaccines. These vaccines are prepared by treating the whole cell or virus with chemicals that cause inactivation. Generally these organisms remain intact and whole. They generate an immune response (to a broad range of antigens) but cannot cause an infection because they are dead and so cannot reproduce. Eg. Hepatitis A, Some influenza vaccines
  • 16. Toxoid vaccines In some bacterial infections (eg, diphtheria, tetanus), the clinical manifestations of disease are caused not by the bacteria themselves but by the toxins they secrete. Toxoid vaccines are produced by harvesting a toxin and altering it chemically (usually with formaldehyde) to convert the toxin to a toxoid. The toxoid is then purified. Toxoid vaccines induce antibodies that neutralise the harmful exotoxins released from these bacteria.
  • 17. Sera Blood = Cells + Plasms Plasma = water + proteins + dissolved substances Serum = Plasma Clotting factors
  • 18. The serum / sera is a portion of blood remaining after coagulation of the blood, during which process plasma protein fibrinogen is converted in to fibrin and remains behind the clot. Antiserum: antiserum is prepared from the blood of animals or humans that have been exposed to disease or infections and have developed specific antibodies, those antibodies were used to protect the persons against the disease. Ex: Hapatoglobin, its a colourless protein of a 留 globulin fraction of human serum
  • 19. Preparation of Serum The blood is allowed to clot at room temperature for 15 to 30 minutes. When the blood has clotted completely, it is rimmed or ringed with an applicator stick. Then centrifuged for 5-10 minutes at 2,500 revolutions per minute (rpm). Finally the supernatant fluid is then separated making use of a Pasteur pipette, and labeled accordingly.
  • 20. Differences between Vaccines and Sera Vaccines Sera Vaccines are preparations of antigenic materials, which are administered with the objective of inducing in the recipient specific and active immunity against infectious microorganisms or toxins produced by them. The clear, pale yellow liquid that separates from the clot in the coagulation of blood. Or Serum is a portion of blood remaining after coagulation of blood. Contain dead bacteria or weak bacteria or toxins Do not contain any bacteria or toxins Stimulates the body to make antibodies Acquired immune immediately Immunity remains for longer time Immunity remains for shorter time Obtained from series of complex process to get live or inactivated vaccines Specific animal by immunisation, whole blood is collected in, but the serum is non- specific mixture obtained after centrifugation. Normally it consists of single type of monoclonal antibodies or may be for a particular disease. It may contain monoclonal or polyclonal antibodies (antiserum)
  • 24. Preparations of Bacterial Vaccines Method Sterilised via low thermal or filtration Ex :Bacillus Calmette Guerin Vaccine (BCG, Tub, Vac) Cholera Vaccine (Vibrio Cholera vaccine) Pertussis Vaccine ( Whooping cough vaccine) Plague Vaccine Gen Storage options Store in dark between 2 to 8 属C B.C.G (Mycobacterium tuberculosis live) Liquid /dry Liquid form 14 days shelf life Dry form 12 months
  • 26. Bacterial toxoids Toxins Endo and exotoxins formaldehyde Toxin Toxoid Precipatation of Toxoid with Alum, flocculating it with corresponding antitoxin Or adsorbing on aluminium hydroxide or hydrated aluminium phosphate. Precipitate is washed and resuspended in isotonic solution with blood. Diphtheria vaccination. Tetanus vaccination
  • 27. Viral or Rickettsial Vaccines Generally they are resistant to Treatment of antibiotic and chemotherapeutic agents Generally prepared from infected tissues, or from the animal, which have been deliberately infected with virus or rickettsiae. (rabies, small pox) Host (fertile Egg) / Cell cultures (poliomyelitis, small pox) Living (live attenuated strains) Non pathogenic Pathogenic - inactivation/ limitations of its activity by treating with formaldehyde or low thermal activity Note : Small pox is availalable in both dry and liquid form Yellow fever vaccine is available only in dry form and other vaccines available in liquid forms.
  • 28. Storage Viral /rickettsial Vaccine Temperature Shelf Life Poliomyelitis Frozen State Two years 0 to 4属C Six months 18 to 20属C 7 days Liquid Small Pox -10 to -20属C 12 months 2 to 8属C Two weeks 10 to 20属C One week Dried Small pox 2 to 10属C Indefinitely At 29属C 1 year Yellow Fever Dry state 4属C 1 year Rabies 2 to 4属C Six months In general other viral or rickettsial vaccines stored between 2 to 8属C in dark place