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 (avaccine) 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 Interleukin
Antibody Serum/Sera
Immunogen Virion
Immunological
TYPES OF
IMMUNITY
THERE ARE TWO MAIN CATEGORIES
OF
IMMUNITY:

Natural Immunity Acquired Immunity

• Species Immunity • Active Immunity
• Racial Immunity •Passive Immunity
•Individual munity
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

 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

lymphocytes augment the

activity of B lymphocytes,
which 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 respon 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
prolongingimmune 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 withimmunocompromised

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
audiation chemotherapy.
 2.1 ACTIVE IMMUNITY

Immunization during pregnancy is

another concern. Live attenuated
vaccines should be avoided for pregnant
patient 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 o
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
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  Water (residual moisture)

applicable to biologic  Pyrogens
products include tests for:
 Identity
 Potency
 Constituent materials
 General safety
(preservatives, diluents,
 Sterility adjuvants)
 Purity  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 us 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 inventor 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
opene 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