BIOLOGICS

Biologics

Definition:
 The term Biologics means any product derived from a living
plant or animal.
OR
 Biologics includes the immunizing biologics that are derivatives
of animals( serums, antitoxins, globulins) that either directly or
indirectly confer a state of protection against pathogenic
micro-organism.
 Preparations that are synthesized from living organisms & their
products & used as diagnostic, preventive & therapeutic agent.
Classification of biologics
Biologics can be classified into two general categories
1. Antigens
2. Antibodies
ANTIGEN:
An antigen is the material that provokes the immune response
and it can be defined under three categories.
Biologically
Chemically
Physically
a. Biologically definition of Antigens:
An antigen is the substance that when introduced into the tissue of man or other
vertebrates, causes the formation of antibodies.
These antibodies then react specifically with the antigen that stimulated their
production.
b. Chemically definition of antigen:
Chemically antigens are Proteins, However some higher molecular weight polysaccharides
are also antigenic.
c. Physically definition of antigen:
Antigen must possess a higher molecular weight .Weight more than 10,000 is required.
The higher molecular weight is associated with the biologic property of
immunogenicity(The capacity to induce antibody formation)
Properties of an antigen:
Immunogenicity
Specificity
ANTIGENIC DETERMINATES(EPITOPES)
Small chemical sites on the antigen molecules called the antigenic determinates, the
antibody combines with one or more these sites.
HAPTENS
“Compounds with a molecular weight lower than 10,000 can be
partial antigens and are called Haptens”.
Because of low molecular weight they cannot induce the
formation of antibodies by themselves and lack the property of
immunogenicity. However they can attached with the host
proteins to form a complete antigen which will induce the
formation of antibodies specific for the particular Hapten.
Examples:
Drug or their breakdown products may act as Hapten and this
action is the basis of many drug allergies e.g. Penicillin Allergy.
Penicillin allergy occurs when immune system mistakenly reacts
to a drug as a harmful substance.
ANTIBODY

An antibody (Ab), also known as an immunoglobulin (Ig), is

a large, Y-shaped protein produced mainly by plasma cells
that is used by the immune system to identify and neutralize
pathogens such as bacteria and viruses.
There are two types of antibodies
1. Circulating antibodies
2. Fixed antibodies
 STRUCTURE OF ANTIBODY
 Antibodies are immune system-related proteins called
immunoglobulins. Each antibody consists of four polypeptides– two
heavy chains and two light chains joined to form a "Y" shaped
molecule.
 The amino acid sequence in the tips of the "Y" varies greatly among
different antibodies.
 This variable region, composed of 110-130 amino acids, give the
antibody its specificity for binding antigenThe variable region includes
the ends of the light and heavy chains. Treating the antibody with a
protease can cleave this region, producing Fab or fragment antigen
binding that include the variable ends of an antibody.

The constant region determines the mechanism used to destroy
antigen. Antibodies are divided into five major classes, IgM, IgG, Iga,
IgD, and IgE, based on their constant region structure and immune
function.
TYPES OF ANTIBODIES

On the basis of physical, chemical and immunological

properties, the immunoglobulins can be divided into five
subtypes.
 IgG (70-75%)
 IgM (10%)
 IgA (10-15%)
 IgD (1% or less)
 IgE(0.001% or less)
IgG IgM IgA IgD IgE
• IgG is the most • When the new • These are found • It is present • Associated
abundant serum born infant in relatively low on the surface with allergic
immunoglobulins begins its own concentration of B-cells and reactions(when
(70-75%). antibody in blood serum. plays a role in immune
• It is the only production ,the • IgA is found in the induction system
antibody that first external of antibody overreact to
can pass through immunoglobulin secretions e.g, production. environmental
the placenta. to appear is saliva, antigen and
• Protects against IgM. secretions of found in lungs,
bacterial or viral • Molecules of IgM respiratory skin, and
infection. are pentamers of tract, GI tract, mucus
• Molecular wt. the basic 4 chain and form a membrane.
approx. 150,000 immunoglobulin specific defense
• Contains 1400 unit. mechanism in
amino acids. • Found mainly in these areas of
blood and in body.
lymph fluids
Types of Immunity
Immunity is classified into two major types.

Natural/Innate Immunity Acqiured Immunity

The term natural or innate means the On the other hand, acquired immunity
defense mechanism andowed at birth is quiet specific and is in contrast to
and that come into play immediately or natural immunity, obtained either from
within hours of an antigen appearance development of antibodies in response
in the body. to exposure of an antigen.
Generally it is subdivided in to 2
classes.
Active immunity
Passive immunity
Active Immunity
a) Naturally acquired active immunity
b) Artificially acquired active immunity
Passive immunity
a) Naturally acquired Passive immunity
b) Artificially acquired Passive
immunity
Active Immunity Passive Immunity
Active immunity means the specific immunity Passive immunity is the type developed by the
developed by an individual in response to the introduction of preformed antibodies into the
introduction of antigenic substance into the body.
body. In this type, the body cells are not stimulated to
a)Naturally acquired active immunity produce their own antibodies .The immunity
In this type of immunity, the antigenic acquired by the individuals is not self developed
substances may be received by the body in a ,but is passed from one individual to another,
natural manner. the term passive immunity is applied.
b)Artificially acquired active immunity a) Naturally acquired Passive immunity
Whereas in this type, antigenic substances may Occurs during pregnancy, in which certain
be received by the body through the antibodies are passed from the maternal into the
administration of vaccines or toxoid. fetal bloodstream.
b) Artificially acquired passive immunity
Short-term immunization by the injection of
antibodies, such as gamma globulin, that are not
produced by the recipient's cells. It is produced
quickly but is not long lasting.
VACCINES
A vaccine is a biological
preparation that provides
active acquired immunity
to a particular disease. A
vaccine typically contains
an agent that resembles a
disease-causing micro-organism
and is often made from weakened or
killed forms of the microbe, its toxins
or one of its surface proteins
 Active immunization from vaccination
 Primary active immunization from vaccination develops more
slowly than the incubation period of most infections and must
be induced prior to exposure to infectious agent.
 Therefore general action of vaccines should be considered
prophylactic.
Active immunization with Non-living Active immunization with living Vaccines
Vaccines
Non living vaccines provides protection for Whereas active immunization with living
only a limited time, so repeated vaccination agents is generally preferable to
is required to maintain protection against immunization with killed vaccines because
Typoid fever, cholera and plague. of a superior and more long lived immune
response.
For example: A single vaccination of
measles, rubella or mumps, is sufficient to
produce a long lasting effects.
Important notes

Use of vaccines is contraindicated under conditions in which

the immune response is depressed e.g.,
 Therapy involving steroids
 Antineoplastic agents
 Immunosuppressive agents
Active immunization may cause fever, malaise, soreness at
injection sites or allergic reactions.
Vaccines don't guarantee complete protection from disease(
some time immune system not response properly & many
other reasons)
VIRAL VACCINE
 For prophylaxis against mumps, rubella, smallpox, and
yellow fever contains living viruses.
 Inactivated or killed viruses are used in influenza and
rabies vaccines.
 Preparations containing live attenuated or killed viruses
are available for immunization against poliomyelitis
1. SMALLPOX VACCINE
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 The smallpox vaccine helps the body to develop immunity
to smallpox.
 The vaccine is made from a virus called vaccinia which is
a “pox”-type virus related to smallpox. The smallpox
vaccine contains the “live” vaccinia virus—not dead virus
like many other vaccines.
 Available in dried and liquid form, the later consist of a
smooth ,aqueous suspension of infected tissue that
contain 40-60% sorbitol/glycerin.
Discovery METHOD OF PREPARATIION USES & DOSE

The pioneering work of Smallpox vaccine is the living virus of Specific immunizing
Dr.Edward Jenner in England vaccinia (cowpox) that has been grown in agent and is used as
in 1796 established that the skin of a vaccinated bovine calf (Young prophylactic before
when a mild case of cowpox domestic cow). infection occur and
(vaccinia) is developed by a The calf is prepared by washing and shaving creates active
person, the same person is its belly then scarifying the epidermis so immunity that lasts
immune to smallpox. that serum oozes through the cuts. for 7 years.
Using this information , he The seed virus is inoculated into
inoculated a young boy with scarifications merely by hand rubbing. DOSE: Percutaneous
pus from a milkmaid infected Calf is maintained in aseptic stall and given and contents of 1
with cowpox . Two months food and water during the growth of virus. capillary tube by
later, the boy was inoculated The vesicles that develop are removed at Multiple Puncture
with pus from a patient the time of maximum potency. Method.
infected with smallpox, but Thoroughly triturated and either made into
no disease developed. a smooth suspension with an aqueous
Immunity had been solution of glycerin or sorbitol or reduced to
established. a dried pellet.
 2.RABIES VACCINE
Rabies vaccine Pathology of infection USES & DOSE H.D.C.V

An active (HUMAN DIPLOID CELL

Rabies vaccine is a immunizing agent CULTURE RABIES
sterile preparation of and is VACCINE):
killed, fixed virus of recommended for A new vaccine
rabies in dried form. the prevention of prepared from virus
The virus is obtained rabies in person grown in culture of
from duck embryos bitten by an Human diploid cells,
that have been animal supposed contains much less
infected with fixed or known to be protein and with less
rabies virus. Duck rabid. chances of side effects
vaccine is sometimes DOSE:
called “Avianized S/C 4-6 post-exposure
vaccine” Injection o.d for doses shows that it is
14 days more effective than
duck embryo vaccine.
3. YELLOW FEVER
Yellow fever is a serious disease caused by the yellow
fever virus. It is spread through the bite of an infected
mosquito and cannot be spread directly from person-to-
person.
YELLOW FEVER VACCINE

Introduction Preparation Use & dose

Yellow fever vaccine is an The virus-infected ,chick Active immunizing agent
attenuated strains of embryo pulp is suspended that is used to develop
yellow fever virus in water and after active immunity against
prepared by culturing the aseptic processing is disease.
virus in the living embryo distributed in suitable S/C 0.5 ml
of the domestic fowl. quantities into ampoules ,
( Gallus domesticus). and then ampoules are
filled with dry nitrogen
and flame sealed.
4. INFLUENZA VIRUS VACCINE
Introduction Preparation Uses & dose
Flu is caused by influenza During commercial Active immunization
viruses, and is spread mainly preparation of vaccine against the disease
by coughing, sneezing, and ,the virus growth are I/M, S/C, 2 inj of 0.5
close contact. collected, concentrated ml ,6-8 weeks apart
Symptoms vary by age but and refined by
can include fever/chills , sore ultracentrifugation and
throat , muscle inactivated by UV
aches ,fatigue , cough, radiations.
headache ,runny or stuffy
nose.
Influenza virus vaccine is a
sterile aqueous suspension of
inactivated Influenza virus
Type A& B , either
individually or combined
prepared from extra
embryonic fluid of influenza
virus infected chick embryo.
5. POLIOMYELITIS VACCINE

POLIOMYELITIS VACCINE Trivalent Oral Polio Vaccine(TOPV)

It is a viral disease that can effect Preparation of one or a combination of
nerves and can lead to partial or full 3 types of live, attenuated virus. It has
paralysis. been manufactured in a manner suited
Preparation: for oral administration. Manufacturing
Poliomyelitis virus of type 1, 2, and 3 is similar to poliovirus vaccine.
and viral strains are grown USES & DOSE:
separately in primary culture of Rhesus Active immunizing agent
monkey kidney tissue. 2 doses at interval of 8 weeks, 3rd dose
USES & DOSE: after interval of 8 months.
Create active immunity against disease
I/M , S/C, 3 Inj. of 1 ml , 4 weeks
apart, 4th reinforcing dose of 1ml 6-
12 months later.
6. MEASLES VACCINES
Introduction i. Measles virus vaccine live or ii) Rubella virus vaccine live/
rubeola vaccine: German measle
Measles: It’s a disease mainly Rubeola vaccine is prepared It is prepared from the Wistar
caused from a virus from attenuated viruses derived Institute RA 23/3 strain grown
named “paramyxo virus”. This from the original Edmoston B on human diploid cell tissue.
is a viral infection of the strain and is claim to have high Uses & Dose:
respiratory system – degree of antigenicity with low Active immunization against
occurring mostly in childhood – incidence of adverse effects. German measle for children
cause fever and red rash. Rubeola virus is grown on aged 1 to puberty.
Measles vaccines containing cultures of chick embryo tissue. Single 0.5ml s/c inj
live attenuated rubeola Uses & Dose:
(measles) and rubella (German Provides active immunization
measles) viruses are available Of children 15 months of age or
for active immunization against older.
the disease. Viruses for Single 0.5ml s/c inj
production of these vaccines
are grown on cultures of either
avian tissue or human diploid
cell tissue
7. MUMPS VACCINE

Introduction Preparation Uses & dose

Mumps is caused by a Mumps virus vaccine is S/C Inj and provides
virus from the genus prepared with the B-level active immunization for
Rubula virus. Its Jeryl Lynn strain of the 10 years
symptoms include low- virus , grown in cell
grade fever, respiratory cultures of chick embryo
problems, and most tissue.
notably swelling of the
salivary glands below the
ear.
COMBINATION VIRUS VACCINE

 Combination live virus vaccines containing either measles virus and rubella
virus, rubella virus and mumps virus or measle virus, rubella virus, mumps
virus. (MMR)
 Dose: S/C Inj of 0.5ml at 15 month age of child

RICKETTSIAL VACCINES
Introduction Typhus Vaccine
Rickettsia are cultured in chick TYPHUS VACCINE: Typhus
embryo or in monkey kidney vaccine is a sterile suspension
tissue cultures in a manner of the killed rickettsial
similar to that of virus. organisms of a strains of typhus
TYPHUS FEVER rickettsiae for antigenic
Typhus is a disease caused by an activity.
infection with USES & DOSE:
the Rickettsia bacteria. Fleas, Active immunizing agent for
mites, lice, or ticks transmit it typhus fever
when they bite you. 2 S/C Injections of 0.5 ml (4
weeks apart), followed by
0.5ml every 6-12 months.
BACTERIAL VACCINES
Bacterial vaccines consist of suspension of attenuated or killed pathogenic bacteria in isotonic sodium
chloride solution or other suitable diluents.

TYPHOID VACCINE CHOLERA VACCINES PLAGUE VACCINE TUBERCULOSIS

VACCINES
Typhoid vaccine is a Sterile suspension of Plague vaccine is a BCG vaccines are dried
sterile suspension killed cholera vibrios sterile suspension , in , living culture of the
containing killed (Vibrio cholerae) is an an isotonic sodium bacillus Calmette-
typhoid bacilli isotonic sodium chloride solution or Guerin strains of
(Salmonella typhi) and chloride other suitable diluent Mycobacterium
consist of 1 billion solution or other ,of killed Plague bacilli tuberculosis isolated by
typhoid organisms in suitable diluents. (Yersinia pestis) and two
each ml contains 2 bacteriologist Calmett
Uses & Dose Uses & Dose: billion plague bacilli in e and Guerin
2 Inj at a Dose of 0.5 S/C, I/M, 0.5 ml and each ml. Uses& Dose: I/D in
ml ,S/C, 4 weeks apart, then 1 ml 4 weeks Uses & Dose doses of 0.1 ml
followed by 0.5ml later, 0.5ml dose 2, 0.5 ml I/M Inj, 4
every 3 years. repeated every six weeks apart, then 0.2
months. ml 4-12 weeks later.
BACTERIAL VACCINES

PERTUSSIS VACCINES MENINIGOCOCCAL PNEUMOCOCCAL

POLYSACCHARIDE VACCINE,POLYVALENT
VACCINE
Pertussis vaccine is a It contains specific Affords protection
sterile bacterial bacterial capsular against 14 most prevalent
suspension of killed polysaccharide for capsular type of
pertussis bacilli Neisseria meningitidis. pneumococci accounts for
(Bordetella pertussis ) Dose: 80% pneumococcal
Bordetella pertussis is Single S/C inj of 0.5 ml diseases and prepared by
the organism that causes containing 50 μg isolating and purifying
the disease known as meningococcal polysaccharide antigen
whooping cough or polysaccharide. from strains of
pertussis. Streptococcus
pneumoniae.
Dose: Single 0.5 ml S/C ,
I/M
 TOXINS
Toxins are bacterial waste products that are poisonous to animal body.
Exotoxins & Endotoxins COMMERCIAL Adsorbed toxoids Fluid toxoids
PREPARATION OF
EXOTOXINS
EXOTOXINS: By adsorbing the fluid Treating exotoxins with
When toxins are excreted from Highly virulent toxoid with aluminium formaldehyde eliminates
bacterial cells producing them organisms are phosphate, aluminum the toxic properties . The
and are dissolved in surrounding cultured in beef hydroxide an adsorbed detoxified products are
culture medium they are broth media and toxoid is produced, is called as Fluid toxoids.
referred as Exotoxins. then killed by when administered, result USES:
appropriate means. in slower release of Fluid and adsorbed
Endotoxins Organisms are antigen from site of toxoids produces active
When toxins are retained within removed by injection and subsequent immunity against
bacterial body , they are called filtration through production of higher or diphtheria and tetanus.
endotoxins. bacterial filter and more prolonged antibody DTP : Diptheria and
filtrate contains titers. tetanus toxoid combined
toxins and other with pertussis vaccine in
products is combination known as
standardized on a DTP.
suitable animal to
determine minimum
ANTITOXINS

 Antitoxins are prepared from bloods of animals, usually horses, that have
been immunized by repeated injections of specific bacterial exotoxins. The
toxin in constantly increasing dose, induces the formation of antitoxins in the
blood of infected animals.

THERAPEUTICALLY IMPORTANT ANTITOXINS


DIPHTHERIA ANTITOXINS
 TETANUS ANTITOXINS
 BOTULISM ANTITOXINS
DIPHTHERIA ANTITOXINS TETANUS ANTITOXINS BOTULISM ANTITOXINS
Sterile, non –pyrogenic solution of It is a steirle , non pyrogenic Sterile , non pyrogenic solution of
the refined and concentrated solution of the refined and refined and concentrated antitoxic
proteins, chiefly globulins concentrated proteins, chiefly antibodies, chiefly globulins,
containing antitoxic antibodies globulins containing antitoxic obtained from blood serum or
obtained from blood serum or antibodies obtained from blood plasma of healthy horse that have
plasma of healthy horses that have serum or plasma of healthy horses been immunized against toxins
been immunized against diptheria immunized against tetanus toxin produced by both type A and type
toxin or toxoid. or toxoids. B and type E strains of
POTENCY: NLT ( NOT LESS THAN) POTENCY: clostridium botulinum
500 antitoxin units per ml NLT 400 antitoxin units per ml Use & Dose: Positive immunizing
USE & DOSE: agent
Passive immunizing agent and Use & Dose: I/V 20,000 units repeated at 2-4
produce passive immunity against Passive immunity against tetanus hr internals as necessary.
diptheria. I/M, S/C
I/M OR I/V Prophylactic dose: 3000-10,000
Prophylactic dose: 1000-10,000 units
units Therapeutic dose: 40,000-
Therapeutic dose: 20,000-80,000 100,000 units
units
VENOMS

 Venoms are poisonous excretions secreted by animals (certain snakes and

spiders), introduce into the bodies of their victims by biting or stinging etc.
 Poisonous snake bite often causes severe pain, amputation and death.
 SNAKE VENOMS/VENINS
Snake venoms are obtained by holding the poisonous snake over a conical
container covered with a sheet of thin rubber . The snake strikes the rubber and
penetrate with its fangs where the semisolid venom is ejected in to the
container.
Antivenom
Mixtures of venins from poisonous snakes of a locality, country or continent are prepared and
used in the preparation of POLYVALENT ANTIVENINS(Anti snakebite serum).

POLYVALENT ANTIVENINS SPIDER- BITE ANTIVENIN

Sterile, non pyrogenic preparations derived by drying a Latrodectus mactans /Black widow
frozen solution of specific venom –neutralizing globulins spider
which are obtained from serum of healthy horses Black widow spider anti-venom is
immunized against 4 species of venomous snakes. prepared by serum obtained from
Family: Crotalidae horses immunized against venom of
Crotalus atrox ( Western diamondback) black widow spider .
4 Feet Use & Dose: I/M, I/V over a 15 min
2. Crotalus adamenteus (Florida diamondback) period , diluted with 10-50 ml saline
7.8 feet solution.
3. Crotalus durissus (South American Rattlesnake
4.9 feet
Bothrops atrox (Common lancehead)
6.6 feet
Dose:
Passive immunizing agent
I/M 10 ml recostitued antivenin
I/V infusion 1:10 dilution of antivenin in Nacl Inj (5%
Dextrose Inj)
ANTISERUMS

Introduction Use & dose

Blood serum that contains specific Use & Dose:
antibodies against an infective Injection provides immediate
organisms or poisonous substances and protection against rabies.
is used to pass on passive immunity to Single dose I/M 1000 units per 40
many diseases. pounds body weight
ANTI-RABIES SERUM:
Sterile, non-pyrogenic solution
containing antiviral substances obtained
from blood serum of plasma of a
healthy horse that have been
immunized against rabies by means of
vaccine.