BIOLOGICS

WHAT IS BIOLOGICS?
A biologic is a substance produced by a living source; it
commonly
includes the following:
• Antibiotics
• Hormones
• Vitamins
• Others
• Provision of immunity through the use of biologic is
immunization.
Vaccination, a term which refers to the use of a biologic
product (a
vaccine) to develop active immunity in the patient.
 WHAT IS BIOLOGICS?

The Food and Drug

Administration (FDA) refers
to immunizing agents
as biologics.
 The Advisory Committee on
Immunization Practices (ACIP)
refers to
immunizing agents as
immunobiologics.
 According to the Code of Federal
Regulations, a biologic product is any
virus, therapeutic serum, toxin,
antitoxin, or analogous product
employed for prevention, treatment,
or cure of diseases in humans.
DEFINITION OF TERMS
• Antigen
• Antibody
• Immunogen
• Immunological
• Interleukin
• Serum/Sera
• Virion
 TYPES OF
IMMUNITY
 THERE ARE TWO MAIN CATEGORIES OF
IMMUNITY:

Natural Immunity Acquired Immunity

• Species Immunity • Active Immunity
• Racial Immunity •Passive Immunity
•Individualmmunity
 1.NATURAL IMMUNITY

Natural, innate, or native immunity

depends on factors that are
inborn.
 1.1 SPECIES IMMUNITY
• In general, cold-blooded animals are not
susceptible to diseases
common to warm-blooded animals.
• Humans are not at all susceptible to
certain diseases of lower
animals and correspondingly, many
human diseases do not
naturally occur in animals.
 1.3 INDIVIDUAL IMMUNITY
• Individuals vary in the ability to resist common
microbiologic
diseases.
• The natural resistance of the same individual
may vary from time
to time.
• Health plays a vital role in resisting invasion by
other species of
microorganisms capable of producing infection.
 2. ACQUIRED IMMUNITY
• T lymphocytes regulate cell-mediated
immunity and are
responsible for controlling certain bacterial
and viral infections.

They are responsible for mediating:

• Graft vs Host disease
• Allograft rejection
• Delayed hypersensitivity reactions
 2. ACQUIRED IMMUNITY
• T lymphocytes augment the
activity of B lymphocytes, which
are primarily involved with humoral
immunity and antibody
production.
 2. ACQUIRED IMMUNITY
• Once exposed to an antigen, the
T and B lymphocytes
demonstrate memory that allows
them to recognize and respond
to a specific antigen when
exposed again.
 2.1 ACTIVE IMMUNITY
Active immunity develops in
response to antigenic substances
in the body.
 2.1 ACTIVE IMMUNITY
This may occur by natural means, as
by infection, in which case it
is termed naturally acquired active
immunity.
 2.1 ACTIVE IMMUNITY
It may also develop in response to
administration of a specific
vaccine or toxoid, in which case it is
artificially acquired active
immunity.
 2.1 ACTIVE IMMUNITY
Vaccines are administered primarily
for prophylactic action, to
develop acquired active immunity.
These may contain living
attenuated (weakened) or killed
microorganisms or fractions of
these microorganism.
 2.1 ACTIVE IMMUNITY
Toxoids are bacterial toxins
modified and detoxified with
moderate heat and chemical
treatment so that the antigenic
properties remain while the
substance is rendered nontoxic.
 2.1 ACTIVE IMMUNITY
A problem with toxoids is that they produce inadequate
immunologic responses when administered alone.
Therefore,
they are often combined with adjuvants such as alum,
aluminum
phosphate, and aluminum hydroxide that enhance
their
antigenicity,
• The insoluble property of these adjuvants help in
prolonging
immune response.
 2.1 ACTIVE IMMUNITY
A vaccine composed of killed whole
microorganisms is known as
inactivated vaccine.

Vaccine that contain live but

significantly weakened microorganisms
are attenuated vaccines.
 2.1 ACTIVE IMMUNITY
Both types are capable of producing
immunity. However, the
attenuated vaccines typically have
more antigenicity so are more likely
to confer permanent immunity.
Inactivated vaccines, however, must be
administered again over time for
maintenance.
 2.1 ACTIVE IMMUNITY
• With live vaccines, caution must be exercise with
immunocompromised patients. This group of patients includes
those
with:
• HIV infection
• Thymic Abnormalities
• Lymphoma
• Leukemia
• Generalized Malignancy
• Advanced debilitating diseases
• Or those receiving corticosteroids, alkylating agents,
antimetabolites, or
radiation chemotherapy.
 2.1 ACTIVE IMMUNITY
Immunization during pregnancy is
another concern. Live
attenuated vaccines should be
avoided for pregnant patients
because of the danger of
transmission of the microorganism
to
the fetus.
 2.2 PASSIVE IMMUNITY
• Passive acquired immunity occurs by
introduction of the
immunoglobulin produced in another
individual (human or
animal) into the host, who is not involved
in their production.
• It can also be classified as natural or
artificial, just like active
immunity.
 2.2 PASSIVE IMMUNITY
Naturally acquired passive
immunity occurs by placental
transmission of immunoglobulin
gamma (IgG) from the mother
to the fetus.
 2.2 PASSIVE IMMUNITY
Artificially acquired passive immunity
include several biologic
products containing immunoglobulins.
These are limited to
provision of temporary prophylaxis to
susceptible individuals.
Notable in this category are the anti-venins
for the treatment of
snakebite and spiders.
PRODUCTION OF
BIOLOGICS
 PRODUCTION OF BIOLOGICS
Biologics are produced by
manufacturers licensed to do so
in
accordance with the terms of
the federal Public Health Service
Act approved July 1, 1944, and;
PRODUCTION OF BIOLOGICS
Each product must meet
specified standard as
administered by
the Center for Biologics
Evaluation and Research of
the FDA.
 PRODUCTION OF BIOLOGICS
Provisions generally applicable to biologic products include
tests for:
• Potency
• General safety
• Sterility
• Purity
• Water (residual moisture)
• Pyrogens
• Identity
• Constituent materials (preservatives, diluents, adjuvants)
• Additional safety tests on live vaccines and certain other
items are also required.
 PRODUCTION OF BIOLOGICS
• The label of a biologic product must include:
• Title or Proper Name (the name under which
the product is licensed)
• Name, address, and license number of the
manufacturer
• Expiration date
• Recommended individual dose for multiple-
dose containers
• Preservative/s used and the amount
• Number of containers (if more than one)
 PRODUCTION OF BIOLOGICS
• Amount of product in the container
• Recommended storage temperature
• Auxiliary statements (e.g. freezing is to
be avoided)
• Other information as FDA regulations
may require to ensure safe and effective
use
of the product.
PRODUCTION OF BIOLOGICS
Most biologics are stored in a
refrigerator (2𝑜 C to 8𝑜 C, or
35𝑜 F to 46𝑜 F), and
freezing is to be avoided.
 PRODUCTION OF BIOLOGICS
Diluents packaged with biologics should
not be frozen.

Beside the biologic substance that is

harmed by freezing, the container may
be broken due to the expansion of an
aqueous vehicle resulting in loss of
product.
 PRODUCTION OF BIOLOGICS
The expiration date for biologic
products varies with the product
and the
storage temperature. Most
biologic products have an
expiration date of a
year or longer after the date of
manufacture or issue.
 STORAGE,
HANDLING,
AND SHIPPING OF
BIOLOGICS
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
Biologics are sensitive to extreme
temperatures, and exposure to
heat or
freezing can decrease their
potency and dramatically reduce
their
effectiveness.
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
Biologics are expensive and can
add significantly to one’s
inventory
costs.
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
A real danger is that if damaged products
are administered, the person
may get little or none of the intended
benefit. Worse, the person may
not be able to build up immunity and
may result in an infection or
inadequate protection from the disease.
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
The overriding theme for the
pharmacist in storage, handling, and
shipping of biologic products is to
maintain the cold chain.
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
This implies continuity from the manufacturer’s refrigerator to one’s
pharmacy, clinic, or office to the point of administration. If this cold chain
is to be maintained, the pharmacist can be assured that the quality of the
product will not be diminished.
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
For small-volume biologics, a standard refrigerator-freezer should be used. Frost-free
freezers should be used because ice buildup interferes with the freezer’s ability to
maintain very low temperatures. Also, defrosting requires that the product be removed
to temporary storage.
 STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
A separate refrigerator dedicated to biologics is preferable to
minimize the time the
refrigerator door is opened. The WHO recommends that the door
not be opened
more frequently that four times per day.
The door shelving can be used to store diluents or
bottles of water. This helps provide
insulation and a thermal reserve.
Refrigerator temperatures should range between 2𝑜
C and 8𝑜 C, and freezers should stay
well below 0𝑜 C. Usually, an optimal temperature is
−15𝑜 C (5𝑜 F).
 Store containers of the same vaccine together.
• To avoid selecting the wrong product or one having
a similar sounding
name or packaging, separate the product.
Look-alike packaging as well as sound-alike names can
easily confuse
any conscientious practitioner.
The use of a mishandled or poorly stored biologic
could have
devastating consequences on the person who
receives it.
BIOLOGICS FOR
ACTIVE
IMMUNITY
THERE ARE FOUR TYPES OF BIOLOGICS FOR
ACTIVE IMMUNITY:
•Bacterial Vaccines
• Viral Vaccines
• Cancer Vaccines
-Autologous tumor vaccines
-Allogeneic tumor vaccines
-Anti-iodotypic vaccines
-Gene therapy – derived vaccines
• Toxoids