BIOLOGICS

Pharmacognosy-I

Apr 23, 2024 1

 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)
or of microscopic plant organisms(vaccine, toxins,
toxoids, tuberculins) that either directly or indirectly
confer a state of protection against pathogenic micro-
organism.
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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.
a) Biologically
b) Chemically
c) Physically
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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.
Properties of an antigen:
1. Immunogenicity
2. Specificity
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 ANTIGENIC DETERMINATES(EPITOPES)
Small chemical sites on the antigen
molecules called the antigenic determinates, the
antibody combines with one or more these
sites.

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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)
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 ANTIGENS DIRECTLY CONCERNED WITH
INFECTIOUS DISEASES

 Exotoxins
 Proteins
 Capsule of bacteria
 Protein coats of virus particles

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 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.
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Examples:
Drug or their breakdown products may act as
Hepten 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.

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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
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 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 antigen

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 STRUCTURE OF ANTIBODY
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
antigen. The 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.
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 STRUCTURE OF 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.

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 STRUCTURE OF ANTIBODY

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 TYPES OF ANTIBODIES
On the basis of physical, chemical and
immunological properties, the immunoglobulins
can be divided into five subtypes.
1. IgG (70-75%)
2. IgM (10%)
3. IgA (10-15%)
4. IgD (1% or less)
5. IgE(0.001% or less)
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1. IgG
 IgG is the most abundant serum
immunoglobulins(70-75%).
 It is the only antibody that can pass through
the placenta.
 Protects against bacterial or viral infection.
 Molecular wt. approx. 150,000
 Contains 1400 amino acids.

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2.IgM
 When the new born infant begins its own
antibody production ,the first immunoglobulin
to appear is IgM.
 Molecules of IgM are pentamers of the basic
4 chain immunoglobulin unit.
 Found mainly in blood and in lymph fluids

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3. IgA
 These are found in relatively low
concentration in blood serum.
 IgA is found in external secretions e.g, saliva,
secretions of respiratory tract, GI tract, and
form a specific defense mechanism in these
areas of body.

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4.IgD
 It is present on the surface of B-cells and plays
a role in the induction of antibody production.

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5. IgE
Associated with allergic reactions(when immune
system overreact to environmental antigen and
found in lungs, skin, and mucus membrane.

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Apr 23, 2024 21
 Types of Immunity
Immunity is classified into two major types.
1. Natural/Innate Immunity
2. Acqiured Immunity
Natural/Innate Immunity
The term natural or innate means the defense
mechanism andowed at birth and that come
into play immediately or within hours of an
antigen appearance in the body.
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 Acqiured Immunity
On the other hand, acquired immunity is quiet
specific and is in contrast to natural immunity.
Generally it is subdivided in to 2 classes.
i. Active immunity
ii. Passive immunity
Each of which is further subdivided into
“Acquired immunity”
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Active Immunity
a) Naturally acquired active immunity
b) Artificially acquired active immunity
Passive immunity
a) Naturally acquired Passive immunity
b) Artificially acquired Passive immunity

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 Active Immunity
Active immunity means the specific immunity
developed by an individual in response to the
introduction of antigenic substance into the body.
a)Naturally acquired active immunity
In this type of immunity, the antigenic substances
may be received by the body in a natural manner.

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b)Artificially acquired active immunity
Whereas in this type, antigenic substances may
be received by the body through the
administration of vaccines or toxoid.

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 Passive Immunity
Passive immunity is the type
developed by the introduction of
preformed antibodies into the body.
 In this type, the body cells are not
stimulated to produce their own
antibodies .The immunity acquired
by the individuals is not self
developed ,but is passed from one
individual to another, the term
passive immunity is applied.

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a) Naturally acquired Passive immunity
Occurs during pregnancy, in which certain
antibodies are passed from the maternal into the
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.

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Apr 23, 2024 30
 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
ofAprits23, surface
2024
proteins 31
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.

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 Active immunization with Non-living
Vaccines
 Non living vaccines provides protection for
only a limited time, so repeated vaccination is
required to maintain protection against
Typoid fever, cholera and plague.

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Active immunization with living Vaccines

Whereas active immunization with living agents

is generally preferable to immunization with
killed vaccines because 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.

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• 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.
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 VIRAL VACCINES

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VIRAL VACCINES

 For prophylaxis against mumps, rubella,

rubeola , 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

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 1. SMALLPOX VACCINE
(‫)چیَچ ک‬
 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 ,aquoeus suspension of
infected tissue that contain 40-60%
sorbitol/glycerin.
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 DISCOVERY OF SMALLPOX VACCINE

The pioneering work of Dr.Edward Jenner in

England in 1796 established that when a mild case
of cowpox (vaccinia) is developed by a person, the
same person is immune to smallpox.
Using this information , he inoculated a young boy
with pus from a milkmaid infected with cowpox .
Two months later, the boy was inoculated with pus
from a patient infected with smallpox, but no
disease developed. Immunity had been established.

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 METHOD OF PREPARATIION
 Smallpox vaccine is the living virus of vaccinia
(cowpox) that has been grown in the skin of a
vaccinated bovine calf (Young domestic cow).
 The calf is prepared by washing and shaving its
belly then scarifying the epidermis so that serum
oozez through the cuts.
 The seed virus is inoculated into scarifications
merely by hand rubbing.
 Calf is maintained in aseptic stall and given food
and water during the growth of virus.
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 The vesicles that develop are removed at the
time of maximum potency.
 Thoroughly triturated and either made into a
smooth suspension with an aqueous solution
of glycerin or sorbitol or reduced to a dried
pellet.

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USES & DOSE
• Specific immunizing agent and is used as
prophylactic before infection occur and
creates active immunity that lasts for 7 years.

DOSE: Percutaneous and contents of 1 capillary

tube by Multiple Puncture Method.

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2.RABIES VACCINE

Rabies vaccine is a sterile

preparation of killed, fixed
virus of rabies in dried
form. The virus is obtained
from duck embryos that
have been infected with
fixed rabies virus. Duck
vaccine is sometimes
called “Avianized vaccine”

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Apr 23, 2024 44
 USES & DOSE
An active immunizing agent and is
recommended for the prevention of rabies in
person bitten by an animal supposed or known
to be rabid.

S/C Injection o.d for 14 days

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 H.D.C.V
(HUMAN DIPLOID CELL CULTURE RABIES
VACCINE):
A new vaccine prepared from virus grown in
culture of Human diploid cells, contains much
less protein and with less chances of side effects
DOSE:
4-6 post-exposure doses shows that it is more
effective than duck embryo vaccine.

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 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.

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Apr 23, 2024 48
 YELLOW FEVER VACCINE
Yellow fever vaccine is an attenuated
strains of yellow fever virus prepared
by culturing the virus in the living
embryo of the domestic fowl.
( Gallus domesticus).

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Preparation:
The virus-infected ,chick embryo pulp is
suspended in water and after aseptic processing
is distributed in suitable quantities into
ampoules , and then ampoules are filled with
dry nitrogen and flame sealed.

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 USES & DOSE
 Active immunizing agent that is used to
develop active immunity against disease.
 S/C 0.5 ml

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 4. INFLUENZA VIRUS VACCINE
Flu is caused by influenza viruses, and is spread
mainly by coughing, sneezing, and close contact.
Symptoms vary by age but can include fever/chills ,
sore throat , muscle aches ,fatigue , cough,
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.
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Preparation:
During commercial preparation of vaccine ,the
virus growth are collected, concentrated and
refined by ultracentrifugation and inactivated
by UV radiations.

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 USES & DOSE
 Active immunization against the disease
 I/M, S/C, 2 inj of 0.5 ml ,6-8 weeks apart

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

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ii) Rubella virus vaccine live/ German measle
It is prepared from the Wistar Institute RA 23/3
strain grown on human diploid cell tissue.
Uses & Dose:
 Active immunization against
German measle for children
aged 1 to puberty.
 Single 0.5ml s/c inj
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 7. MUMPS VACCINE
Mumps is caused by a virus from the genus
Rubula virus. Its symptoms include low-grade
fever, respiratory problems, and most notably
swelling of the salivary glands below the ear.
Prepatration:
Mumps virus vaccine is prepared with the B-
level Jeryl Lynn strain of the virus , grown in
cell cultures of chick embryo tissue.

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Dose & Uses:
S/C Inj and provides active immunization for 10
years

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 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

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 RICKETTSIAL VACCINES
Rickettsia are cultured in chick embryo or in
monkey kidney tissue cultures in a manner
similar to that of virus.
TYPHUS FEVER
Typhus is a disease caused by an infection with
the Rickettsia bacteria. Fleas, mites, lice, or ticks
transmit it when they bite you.

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TYPHUS VACCINE: Typhus vaccine is a sterile
suspension of the killed rickettsial organisms of
a strains of typhus rickettsiae for antigenic
activity.
USES & DOSE:
Active immunizing agent for typhus fever
2 S/C Injections of 0.5 ml (4 weeks apart),
followed by 0.5ml every 6-12 months.

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 BACTERIAL VACCINES
Bacterial vaccines consist of suspension of
attenuated or killed pathogenic bacteria in
isotonic sodium chloride solution or other
suitable diluents.
1) TYPHOID VACCINE
Typhoid vaccine is a sterile suspension
containing killed typhoid bacilli (Salmonella
typhi) and consist of 1 billion typhoid organisms
in each ml
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Uses & Dose
2 Inj at a Dose of 0.5 ml ,S/C, 4 weeks apart,
followed by 0.5ml every 3 years.

2)CHOLERA VACCINES:
Sterile suspension of killed cholera vibrios
(Vibrio cholerae) is an isotonic sodium chloride
solution or other suitable diluents.
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Uses & Dose:
S/C, I/M, 0.5 ml and then 1 ml 4 weeks later,
0.5ml dose repeated every six months.
3) PLAGUE VACCINE:
Plague vaccine is a sterile suspension , in an
isotonic sodium chloride solution or other
suitable diluent ,of killed Plague bacilli (Yersinia
pestis) and contains 2 billion plague bacilli in
each ml.
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 5. TUBERCULOSIS VACCINES
BCG vaccines are dried , living culture of the
bacillus Calmette-Guerin strains of
Mycobacterium tuberculosis isolated by two
bacteriologist Calmette and Guerin
Uses& Dose: I/D in doses of 0.1 ml

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Uses & Dose
2, 0.5 ml I/M Inj, 4 weeks apart, then 0.2 ml 4-12
weeks later.
4) PERTUSSIS VACCINES
Pertussis vaccine is a sterile bacterial suspension
of killed pertussis bacilli (Bordetella pertussis )
Bordetella pertussis is the organism that causes
the disease known as whooping cough or
pertussis.
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 6. MENINIGOCOCCAL POLYSACCHARIDE
VACCINE
• It contains specific bacterial capsular
polysaccharide for Neisseria meningitidis.
Dose:
Single S/C inj of 0.5 ml containing 50 μg
meningococcal polysaccharide.

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 7. PNEUMOCOCCAL
VACCINE,POLYVALENT
Affords protection against 14 most prevalent
capsular type of pneumococci accounts for 80%
pneumococcal diseases and prepared by
isolating and purifying polysaccharide antigen
from strains of Streptococcus pneumoniae.
Dose: Single 0.5 ml S/C , I/M

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 TOXINS & ANTITOXINS
Toxins are bacterial waste products that are
poisonous to animal body.
EXOTOXINS:
When toxins are excreted from bacterial cells
producing them and are dissolved in
surrounding culture medium they are referred
as Exotoxins.

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ENDOTOXINS:
When toxins are retained within bacterial body , they
are called endotoxins.
COMMERCIAL PREPARATION OF EXOTOXINS
Highly virulent organisms are cultured in beef broth
media and then killed by appropriate means.
Organisms are removed by filtration through bacterial
filter and filtrate contains toxins and other products is
standardized on a suitable animal to determine
minimum lethal dose.
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FLUID TOXOIDS
Treating exotoxins with formaldehyde eliminates the
toxic properties . The detoxified products are called as
Fluid toxoids.
ADSORBED TOXOIDS
By adsorbing the fluid toxoid with aluminium
phosphate, aluminum hydroxide an adsorbed toxoid is
produced, is when administered, result in slower
release of antigen from site of injection and subsequent
production of higher or more prolonged antibody titers.
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USES:
Fluid and adsorbed toxoids produces active
immunity against diphtheria and tetanus.
DTP : Diptheria and tetanus toxoid combined
with pertussis vaccine in combination known as
DTP.

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 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.

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 THERAPEUTICALLY IMPORTANT
ANTITOXINS
1. DIPHTHERIA ANTITOXINS
2. TETANUS ANTITOXINS
3. BOTULISM ANTITOXINS

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 1.DIPHTHERIA ANTITOXINS

Sterile, non –pyrogenic solution of the refined

and concentrated proteins, chiefly globulins
containing antitoxic antibodies obtained from
blood serum or plasma of healthy horses that
have been immunized against diptheria toxin or
toxoid.
POTENCY: NLT ( NOT LESS THAN) 500 antitoxin
units per ml

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USE & DOSE:
Passive immunizing agent and produce passive
immunity against diptheria.
I/M OR I/V
Prophylactic dose: 1000-10,000 units
Therapeutic dose: 20,000-80,000 units

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 2. TETANUS ANTITOXINS
It is a steirle , non pyrogenic solution of the
refined and concentrated proteins, chiefly
globulins containing antitoxic antibodies
obtained from blood serum or plasma of healthy
horses immunized against tetanus toxin or
toxoids.
POTENCY:
NLT 400 antitoxin units per ml

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Use & Dose:
Passive immunity against tetanus
I/M, S/C
Prophylactic dose: 3000-10,000 units
Therapeutic dose: 40,000-100,000 units

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 3. BOTULISM ANTITOXINS
• Sterile , non pyrogenic solution of refined and
concentrated antitoxic antibodies, chiefly globulins,
obtained from blood serum or plasma of healthy
horse that have been immunized against toxins
produced by both type A and type B and type E
strains of clostridium botulinum
Use & Dose: Positive immunizing agent
I/V 20,000 units repeated at 2-4 hr internals as
necessary.

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 VENOMS & ANTI-VENOMS

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 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.

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 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.

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• 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: Sterile, non pyrogenic
preparations derived by drying a frozen solution
of specific venom –neutralizing globulins which
are obtained from serum of healthy horses
immunized against 4 species of venomous snakes.
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Family: Crotalidae
1. Crotalus atrox ( Western diamondback)
4 Feet
2. Crotalus adamenteus (Florida diamondback)
7.8 feet
3. Crotalus durissus (South American Rattlesnake
4.9 feet
4. Bothrops atrox (Common lancehead)
6.6 feet
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 Uses and Dose
• Passive immunizing agent
• I/M 10 ml recostitued antivenin
• I/V infusion 1:10 dilution of antivenin in Nacl
Inj (5% Dextrose Inj)

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SPIDER- BITE ANTIVENIN
Latrodectus mactans /Black widow spider
Black widow spider anti-venom is prepared by
serum obtained from horses immunized against
venom of black widow spider .
Use & Dose: I/M, I/V over a 15 min period ,
diluted with 10-50 ml saline solution.

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 ANTISERUMS
Blood serum that contains specific antibodies
against an infective organisms or poisonous
substances and is used to pass on passive
immunity to many diseases.
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.
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Use & Dose:
Injection provides immediate protection against
rabies.
Single dose I/M 1000 units per 40 pounds body
weight

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