biologics “A biologic drug ( biologics ) is a product that is produced from living organisms or contain components of living organisms” The broad term “ BIOLOGICS ” , includes the “ IMMUNIZING BIOLOGICS ” that are the derivatives of both animals and plants. Derivatives of animals (serum , antitoxins , globulins) Derivatives of plants (vaccines , toxins , toxoids , tuberculins) They directly or indirectly confer a state of protection against pathogenic microorganisms. Biologics are not classified as chemotherapeutic agents or antibiotics. Biologics are classified into two general categories : antigen antibody
Antigen and antibody Antigen “ a toxin or other foreign substance which induces an immune response in the body, especially the production of antibodies.” Antigen can also be defined as: Antibody “a blood protein produced in response to and counteracting a specific antigen. Antibodies combine chemically with substances which the body recognizes as alien, such as bacteria, viruses, and foreign substances in the blood.” It is a large Y shaped molecule that neutralize the pathogens. It has following five types:
Antibody structure
vaccines “A substance used to stimulate the production of antibodies and provide immunity against one or several diseases, prepared from the causative agent of a disease.” vaccines may contain living , attenuated , or killed virus , attenuated or killed bacteria and they are used as inoculations to stimulate the production of antibodies. The general action of vaccine should be considered prophylactic. Non living vaccine provide protection for limited time and repeated vaccine is required to provide protection against typhoid fever, plaque, cholera and typhus. Active immunization is the induction of immunity after exposure to an antigen.
Immunity and vaccination
Immune system
Cultivation of viral culture The cultivation of virus poses a problem because they completely depend on living organisms for their sustenance . Vaccines are obtained from many animals. The use of chick or duck embryos for viral culture offers advantages in some cases , but the development of techniques for tissue culture of mammalian cells provide major basic advancement necessary for significant expansion in practical use of many viral vaccines. The vaccines are also grown on tissue cultures prepared from chick embryo , monkey kidney or human diploid cells .
Types of vaccines There are two types of vaccines. VACCINES VIRAL VACCINES BACTERIAL VACCINES First of all I am going to discuss VIRAL VACCINES Viral vaccines are used to kill viruses . Living viral vaccines are used for prophylaxis against mumps , rubella , small pox Nonliving or inactivated or killed vaccines are available for rabies and influenza.
Points to be discussed Sources Preparation Dose Storage Uses
SMALLPOX VACCINE “The smallpox vaccine protects people from smallpox by helping their bodies develop immunity to smallpox . The vaccine is made from a virus called vaccinia, which is a poxvirus similar to smallpox , but less harmful.” Sources of vaccine : It is the living virus of vaccinia (cow pox) that has been grown in the skin of a vaccinated bovine calf.
CONTINUE… Preparation of vaccine : The vaccine is prepared by skin of calf . The calf is prepared by washing and shaving its belly, then scarifying so that the serum oozes through the cuts. The seed virus is then inoculated into the scarifications merely by hand rubbing. The calf is maintained in aseptic conditions. The vesicles that develop are removed at the time of maximum potency, thoroughly triturated and either made into smooth suspension with any aqueous solution of glycerin or sorbitol or reduced to dried pellet. The animal must have good health prior to inoculation . After the virus is harvested , the animal is killed . Storage of vaccine: liquid vaccine is stored below 0 ̊c because it loses its potency at high temperature. Dried vaccine is stored at temperature between 2 and 8 ̊c
CONTINUE… Uses and dose : Small pox vaccine is a specific immunizing agent and is used as prophylactic before the infection occurs . It creates any immunity that lasts for about 7 years. Usual dose , is percutaneous contents of 1 capillary tube by multiple – puncture method.
RABIES VACCINE “Rabies vaccine is a sterile preparation of killed , fixed virus of rabies in dried form .” Sources of vaccine: 2 Modern rabies vaccines , made from cell-culture or duck-embryo- derived rabies virus which is then purified and inactivated, are replacing the older vaccines produced in brain tissue
CONTINUE… Preparation of vaccine: This vaccine is prepared in primary chick embryo cells derived from specific pathogen-free (SPF) eggs . It is a freeze-dried preparation consisting of purified and concentrated rabies virus antigen inactivated with B-propiolactone. Rabies vaccine of duck embryo origin contains little or no myelin, the “the paralytic factor” that causes rabies treatment paralysis. Duck vaccine is sometimes called “ avianized ” vaccine. The vaccine from brain tissue contains significant amount of myelin. Diploid rabies vaccine is a new vaccine prepared from virus grown in cultures of human diploid embryo lung tissue. Because it contains less protein then duck embryo.
CONTINUE… Storage of vaccine : It should be stored at temperature between 2 and 8 ̊c. Uses and dose: The vaccine is an active immunizing agent and is recommended primarily for prevention of rabies in persons bitten by rabid animal. The usual administration is a subcutaneous injection once a day for 14 days.
Yellow fever vaccine “Yellow fever vaccine is an attenuated strain of living yellow fever virus , selected for highly antigenic activity .” The other name of this vaccine is 17D vaccine. SOURCE: The yellow fever vaccine is made by growing yellow fever virus in mouse embryo cells and in chick embryo cells. The final preparation of the vaccine is made in eggs.
CONTINUE… Preparation of vaccine : It is prepared by culturing the virus in the living embryo of domestic fowl. The virus-infected, chick-embryo pulp is suspended in water and, after appropriate aseptic processing it is distributed in suitable quantities into amplus and dried from the frozen state. After-ward, the amplus are filled with dry nitrogen and flame – sealed. Storage of vaccine it is preferably store at temperature below 0 ̊c but never above 5 ̊c.
CONTINUE… Uses : This vaccine is used to help prevent yellow fever in adults and children who are at least 9 months old The vaccine provides effective immunity within 30 days for 99 percent of those vaccinated. Travel to affected areas should not begin before this time. One vaccination of yellow fever vaccine is enough to build life-long immunity against Yellow Fever. Dose The usual dose given subcutaneously is 0.5 ml
Influenza vaccine “Influenza virus vaccine is a sterile aqueous suspension of suitably inactivated influenza virus types A and B either individually or combined or virus subunits prepared from extra embryonic fluid of influenza virus .” Sources of vaccine : It is made by growing the viruses inside fertilized chicken eggs . This means that they contain a small amount of egg protein.
CONTINUE… Preparation of vaccine: The strains of influenza virus used in the preparation of this vaccine are those designated for the particular season . It contains a suitable preservative and may contain an adsorbent such as aluminum phosphate or protamine. During the commercial preparation of the vaccine, the virus growths are collected, concentrated, refined by ultracentrifugation , and inactivated by ultraviolet irradiation. These CVVs are then injected into fertilized hen's eggs and incubated for several days to allow the viruses to replicate. The fluid containing virus is harvested from the eggs. Each lot of influenza virus vaccine must be tested to determine its potency; its power to stimulate the formation of specific virus-neutralizing antibodies in mice is correlated with the potency.
CONTINUE… Storage of vaccine : the storage temperature is between 2 and 8 ̊c Uses & Dose: Influenza virus vaccine is an active immunizing agent. Its usual dose is 0.5 ml intramuscularly, preferably in the Span-deltoid muscle.
Poliomyelitis VACCINE “Poliomyelitis vaccine inactivated is a sterile suspension of inactivated poliomyelitis virus of types 1, 2 , 3.” Sources of vaccine : IPV. The first inactivated polio vaccine (IPV) was produced by Salk using virus grown on monkey kidney cells and inactivated with formalin.
CONTINUE… Preparation of vaccine: The Salk vaccine, IPV, is based on three wild, virulent reference strains, Mahoney (type 1 poliovirus), MEF-1 (type 2 poliovirus), and Saukett (type 3 poliovirus), grown in a type of monkey kidney tissue culture (Vero cell line), which are then inactivated with formalin. The injected Salk vaccine confers IgG-mediated immunity in the bloodstream, which prevents polio infection from progressing to viremia and protects the motor neurons, thus eliminating the risk of bulbar polio and post-polio syndrome.
CONTINUE… Storage of vaccine : Vaccine is potent if stored at not higher than -20°C until the expiry date indicated on the vial. It can be stored for up to six months between +2°C and +8°C. Uses and dose of vaccine : The usual administration schedule involves an initial administration of 2 doses at not less than 8-week intervals. A third, reinforcing dose is administered to 12 months later. The volume of vaccine indicated on the label as representing one dose is generally placed on a cube of sugar, which is eaten by the individua! to be immunized.
MUMPS AND MEASLES VACCINE “Vaccines containing live attenuated rubeola (measles) and rubella (German measles) viruses are available for active immunization .” Other name : MMR vaccine Sources : Vaccine live is prepared with the B-level Jeryl Lynn strain of the virus, which is grown in cell cultures of chicken embryo tissue. mumps measles
CONTINUE… Preparation of vaccine: It's grown in cultures of chick embryos basically, unhatched live eggs. Lots of vaccines are grown that way it's old-fashioned technology but it works. A 25 gauge, 5/8" needle is recommended. To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine . Single Dose Vial — First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Storage of vaccine : M-M-R ® II must be stored between -58°F and +46°F (-50°C to +8°C ). Use of dry ice may subject M-M-R ® II to temperatures colder than -58°F (-50°C). Before reconstitution, store the lyophilized vaccine at 36°F to 46°F (2°C to 8°C).
CONTINUE… Uses and dose : MMR vaccine is very effective at protecting people against measles , mumps , and rubella , and preventing the complications caused by these diseases. People who received two doses of MMR vaccine as children according to the U.S. vaccination schedule are usually considered protected for life and don't need a booster dose. It provides active immunity for at least 10 years after immunization and is particularly valuable to susceptible individuals approaching puberty and to adults.
RICKETTSIAL VACCINE “Two types of vaccines against Rickettsial infections have been developed and used in humans, whole killed bacteria and live attenuated rickettsiae.” Sources of vaccine : it is obtained from chicken embryo or monkey kidney.
CONTINUE… Preparation of vaccine : Rickettsiae are cultured in chick embryos or in monkey kidney tissue cultures in a manner similar to that for viruses. They cannot be grown in artificial culture media and must be subjected to the same precautions as viruses. At the present time, Rickettsial vaccines are not produced commercially in the United States. Storage of vaccine : It is stored at 4 ̊c. Dose: it is given 100 mg twice per day.
TYPHUS VACCINE “Typhus vaccine is a sterile suspension of killed rickettsial organisms of strain or strains of epidemic typhus rickettsiae selected from antigenic efficiency.” Sources of vaccine : It is obtained by culturing the yolk sac membrane of developing embryo of the domestic fowl and the rickettsiae are killed by suitable chemical agents.
CONTINUE… Preparation of vaccine : One typhus vaccine consists of formaldehyde-inactivated Rickettsia prowazekii. Two doses are injected subcutaneously four weeks apart. Booster doses are required every six to twelve months. Storage of vaccine : Vaccine potency is dependent upon storage under refrigeration [between 2 °C and 8 °C (35.6 °F– 46.4 °F)]. The vaccine should be stored under refrigeration at all times. It is essential to replace unused vaccine in the refrigerator between doses. The expiration date is not later than 18 months after the date of issue.
CONTINUE… Uses and dose: An active immunizing agent for epidemic typhus fever is administered as a prophylactic measure particularly to travelers. The usual administration involves two subcutaneous injections of 0.5 ml 4 or more weeks apart , followed by 0.5 ml every 6 to 12 months for as long as protection is desired.
COMBINATION VACCINES “ Combination vaccines take two or more vaccines that could be given individually and put them into one shot. Children get the same protection as they do from individual vaccines given separately—but with fewer shots.” These combination vaccines are administered subcutaneously to children 15 months of age or older. Use in infants under 15 months of age is not recommended
CONTINUE… Uses Combination vaccines combine protection against 2 or more diseases into one shot . The measles, mumps, and rubella vaccine (MMR) and diphtheria, tetanus ,and pertussis vaccine (DTaP) each protect your child against three diseases.
BACTERIAL VACCINES Bacterial vaccines consist of suspensions of attenuated or , more commonly killed pathogenic bacteria in isotonic sodium chloride solution or other suitable diluents. Properties Strains must be selected on the basis of high antigenicity. The smooth “S” strains are uniformly more antigenic than rough “R” strains.
Typhoid vaccine “Typhoid vaccine is a sterile suspension containing killed typhoid bacilli of a strain selected for high antigenic efficiency.” Sources of vaccine : It contains 1 billion typhoid organisms in each ml and not more than 35µg of total nitrogen.
CONTINUE… Preparation of vaccine: Heat inactivated phenol preserved vaccine ( TAB vaccine ): Prepared by heating S. typhi, S. Para typhi A and S. Para typhi B cultures at 56 o C for one hour and then suspending in 0.5% phenol solution. Storage of vaccine: The vaccine should be stored at temperature 2 to 8 ̊ c. Uses and dose: It is active immunizing agent against typhoid fever. The immunization schedule involves two 0.5 ml subcutaneous injections at least 4 years apart. After that 0.5 ml every three years thereafter.
CHOLERA VACCINE “Cholera vaccine is a sterile suspension of killed cholera vibrios ( Vibrio cholera ) in isotonic sodium chloride solution or other suitable diluent.” Sources of vaccine : A vaccine consisting of killed whole-cell V. cholerae O1 in combination with a recombinant B-subunit of cholera toxin .
CONTINUE… Preparation of vaccine : It is prepared from equal portions of suspensions of cholera vibrios of inaba and ogawa strains. At the time of manufacture , cholera vaccine contains approximately 8 billion cholera organisms in each ml. Storage of vaccine : The vaccine should be stored at a temperature between 2 to 8 ̊c. Uses and dose : It is an active immunizing agent in the development of immunity . Its dose in adult is 0.5 ml intramuscularly or subcutaneously and then 1ml 4 weeks later . 0.5 ml dose is repeated every 6 months.
PERTUSSIS VACCINE “It is a sterile bacterial fraction or suspension of killed pertussis bacilli ( Bordetella pertussis) of a strain or strains selected for high antigenic efficiency.” Pertussis vaccine is a vaccine that protects against whooping cough (pertussis). There are two types :whole cell vaccine and acellular vaccine. The whole cell vaccines about 78% effective while the acellular vaccine about 71-85 %effective.
CONTINUE… Preparation of vaccine : The pertussis vaccine is made by taking two to five of these toxins and inactivating them with a chemical. The inactivated toxins are called "toxoids." Once injected, the toxoids elicit an immune response against the toxins, but, unlike the toxins, they don't cause disease. Absorbed pertussis vaccine consist of pertussis vaccine that has been precipitated or adsorbed by the addition of aluminum hydroxide or aluminum phosphate. It is same as pertussis vaccine but has more than 850µg of aluminum in the volume stated in the labeling constitute of 1 injection.
CONTINUE… Storage of vaccine : pertussis vaccines refrigerated between 2°C and 8°C (36°F and 46°F) Uses and dose : Pertussis vaccine is an active immunizing agent used to treat immunity. The Tdap vaccines protects teens and adults from tetanus, diphtheria and whooping cough. The usual dose is 3 injections usually 0.5 ml or 1ml as specified at least 3to 4 weeks apart.
PLAGUE vaccine “It is a sterile suspension in an isotonic sodium chloride solution or other suitable diluent of killed plague bacilli ( Yersinia pestis) of a strain selected for high antigenic efficiency.” Sources of vaccine : It contains 2 billion plague bacilli in each ml.
CONTINUE… Preparation of vaccine : Recommended antimicrobials include tetracyclines, chloramphenicol, or streptomycin. The plague vaccine licensed for use in the United States is prepared from Y. pestis organisms grown in artificial media, inactivated with formaldehyde, and preserved in 0.5% phenol . Storage of vaccine : It is stored at standard indoor room temperatures , usually considered to be between 20°C and 25°C (68°F and 77°F).
CONTINUE… Uses and dose: Plague vaccine is used to develop immunity against disease. It is restricted to travelers . Its dose include two 0.5 ml intramuscular injections , at least 4 weeks apart, then 0.2 ml 4 to 12 weeks later
BCG VACCINE “Bacillus Calmette–Guerin vaccine is a vaccine primarily used against tuberculosis. It is a freeze dried preparation of the culture of an attenuated strain of bovine tuberculosis .” Sources of vaccine : The vaccine was originally developed from Mycobacterium bovis, which is commonly found in cows ,while it has been weakened ,it is still live.
CONTINUE… Preparation of vaccine: The bcg vaccine is prepared from a weakened strain of mycobacterium bovis. Many foreign born person have been BCG vaccinates .BCG vaccine is used in many countries with a high prevalence of TB to prevent childhood tuberculous meningitis and milliary disease. Storage of vaccine : The expiration date of BCG vaccine is up to one year , if stored at 5 ̊c.
CONTINUE… Uses and dose: BCG vaccine provides immunity or protection against Tuberculosis(TB) .The vaccine may be given to persons at high risk of developing TB It also used to treat bladder Tumors or bladder cancer .This medication is sometime prescribed for other uses to treatment many bacterial infection diseases. It is administered intradermally as a reconstituted vaccine in the doses of 0.1 ml.