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BIOLOGICS
PRESENTED BY:
13 GO, REAGAN TYLER L.
14 GONZALES, ROBERT
DOMINIC D.
15 GRANDE, MA. CLARMINA R.
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.
DEFINITION OF TERMS
Antigen
Antibody
Immunogen
Immunological
Interleukin
Serum/Sera
Virion
PART I
TYPES OF
IMMUNITY
Natural Immunity
Species Immunity
Racial Immunity
Individual
Immunity
Acquired Immunity
Active Immunity
naturally acquired active immunity
artificially acquired active immunity
Passive Immunity
naturally acquired passive
immunity
artificially acquired passive
immunity
The natural resistance of the same individual may vary from time
to time.
PART II
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
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)
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 (2 C to 8 C, or 35 F to 46 F), and
freezing is to be avoided.
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.
PART III
STORAGE, HANDLING,
AND SHIPPING OF
BIOLOGICS
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 2 C and 8 C, and freezers should stay
well below 0 C. Usually, an optimal temperature is 15 C (5 F).
PART IV
BIOLOGICS FOR ACTIVE
IMMUNITY
Bacterial Vaccines
Viral Vaccines
Cancer Vaccines
Toxoids
Following a suitable amount of time for bacterial growth, the cell culture
is processed in two steps:
Step 1: If the vaccine is to be inactivated, the organisms are treated with phenol or
formaldehyde. (Heat and phenol or heat and acetone are employed for typhoid
fever vaccine).
Step 2: Next, the organisms are separated from the medium through centrifugation
and suspended in sterile water or 0.9% sodium chloride for injection.
Subunit vaccines have had limited clinical utility because of the inability to produce
a sufficient, specific immune response.
The final vaccine may contain one single immunogen (monovalent) or it may
contain multiple immunogens (polyvalent, trivalent) to promote immunity
against the same disease.
Viruses cannot be grown on inanimate media employed to grow bacteria and thus,
are propagated on one of several types of animate media.
Embryonic egg
Cell cultures of chick embryo
Human diploid cell culture
Monkey cell culture
Skin of living calves
Intact mice
After the growth of the culture, various techniques are employed to separate the
virus from the host cell. Purification steps are taken to reduce incidence of
hypersensitivity reactions to animate media or host cells.
The vaccine may remain as the whole virion or be further chemically processed
to split into a subvirion vaccine.
tissue culture infection doses, the quantity of virus estimated to infect 50%
of inoculated cultures
Micrograms of immunogen
International units
D-antigen units
Plaque-forming units for yellow fever vaccine
T cells, lymphokine-activated killer cells, and natural killer cells have antitumor
activity. Thus, tumor vaccine development is to stimulate these immune cells
instead of antibody-producing cells, the operational model used to protect one
from an infection.
These cells are killed or attenuated and reinfused into the patient.
A major problem with this approach is the work and cost associated with the
production of vaccine for the individual patient. Also, some tumors escape the
immune system because their antigens are not expressed on the tumor surface.
These vaccines are produced from cell lines that express tumor-specific or
shared TAAs.
To induce an immune response, either the fragment of the allogeneic tumor cell
or the whole cell is injected.
The beneficial aspect of this vaccine is that it can be used in a wide population
of patients.
Antibodies that bind TAAs are isolated and injected into mice. The resulting
antibodies are harvested and used to vaccinate another mouse. The resulting
anti-bodies have a three-dimensional binding site that mimics the original
structure of the TAA.
Because the anti-iodotypic antibody closely resembles the antigen, these can be
used to induce immune responses (cellular, antibody-antigen) to a given
antigen.
4.4 TOXOIDS
Bacteria are propagated, and after the required growth is achieved, the culture is filtered
through a sterilizing membrane filter. The filtrate that contains the toxin (exotoxin) is
then processed.
The detoxified toxin (toxoid) may be plain or contain an adjuvant. The product may
also contain single, multiple, or mixed immunogens.
A mixed biologic has two toxoids and a vaccine in single dosage form for active
immunization against different toxicities and infection.
4.4 TOXOIDS
The strength of a toxoid is in flocculating (Lf)) units.
e.g. Tetanus toxoid, 4 to 5 Lf U/0.5 mL dose
PART V
BIOLOGICS FOR PASSIVE
IMMUNITY
The pooled plasma from adult donors must be free of hepatitis B antigen and
antibodies to HIV.
Processing steps include:
Further purification takes place with a finished biologic product that contains
n.l.t 15% and n.m.t 18% protein. There are exceptions such as the varicella-zoster
immunoglobulins (VZIGs) which contain n.l.t 10% proteins.
Before using these products, precautions must be taken to ensure the safety of
the patient, who may be sensitive to horse protein. Sensitivity tests may be
undertaken to detect any dangerous hypersensitivity.