biologics reporting
TRANSCRIPT
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Chapter 16: Biologics
2D-PHAY 2014-201533 Rapinan, Erika Faye34 Rariza, Mary Chelsea35 Rifareal, Katrina Isabel36 Rodriguez, Alecs Dale
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DEFINITION OF IMMUNITY The condition of being immune, the protection against
infectious disease conferred either by the immune response
generated by immunization or previous infection or by other
non-immunologic factors.
The quality of being unaffected by something. The state of not being susceptible.
The condition in which an organism can resist disease.
(www.biology-online.org)
The ability of an organism to resist a particular infection or
toxin by the action of specific antibodies or sensitized white
blood cells.
(www.oxforddictionaries.com)
Origin: Latin word Immunitas, from Immunis in the sense, an
exemption from a liability.
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2 Main Categories:
1) NATURAL
2) ACQUIRED
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NATURAL IMMUNITYNatural, innate or native immunity:
Depends on inborn factors
Classified as:
1) SPECIES IMMUNITY
2)RACIAL IMMUNITY
3)INDIVIDUAL IMMUNITY
Natural immunity
-Immunity that is
naturally existing.
-does not require priorsensitization to an
antigen.(www.medicineNet.com)
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1) SPECIES IMMUNITYCold-blooded animals are not susceptible to diseases
common to warm-blooded animals.
Humans are not all susceptible to certain disease of
lower animals (chicken cholera).Humans are susceptible to a number of infections that
occur primarily in animals (anthrax: cattle, sheep,horses)(plague: rodents)( rabies: cats, dogs, bats and
others).Animals are not susceptible to a number of human
diseases (gonorrhea, typhoid fever, influenza,measles, mumps, poliomyelitis).
Species immunity
-a form of natural immunity
shared by all members of a
species.(www.medical-
dictionary.thefreedictionary.com)
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SUMMARY:
Certain animals are naturally resistant or not susceptible to
certain pathogens.
Certain pathogens infect only humans, not lower animals.
On the other hand, certain pathogens do not infect humans.
It could be due to:
1) Absence of specific tissue or cellular receptors for
attachment (colonization) by the pathogen.
2) Temperature of the host and ability of pathogen to grow.
3) Lack of the exact nutritional requirements to support thegrowth of the pathogen.
4) Lack of a target site for a microbial toxin.
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2) RACIAL IMMUNITYHuman races differ in susceptibility to common
infections (yellow fever, pneumonia,tuberculosis).
Factors that det. Racial immunity- ELUSIVE andNOT WELL KNOWN.
Should not be used synonymously/confused withEnvironmental immunity:
-result of resistance to infection amongindividuals in a community resulting from thedegree of acquired immunity & other factors(nutrition, genetic constitution, fatigue).
Racial immunity
-a form of natural immunity
shared by most of the members
of a genetically relatedpopulation.
(www.medical-
dictionary.thefreedictionary.com)
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3) INDIVIDUAL IMMUNITY Individuals vary in the ability to resist common microbiologic diseases.
Some individuals have little capacity to resist skin disorders, the
common cold and other familiar diseases.
The natural resistance of the same individual may vary from time to
time.
Reasons why individuals of the same animal species may exhibit greater
or lesser susceptibility to the same ineffective agent could be due to:
1) Age
2) Sex
3) Stress
4) Diet, malnutrition
5) Intercurrent disease or trauma
6) Therapy against other diseases
Individual immunity
-a form of natural immunity
not shared by most other
members of the race and
species.-It is rare and probably occurs
as the result of an infection
that was not recognized
when it occurred.(www.medical-
dictionary.thefreedictionary.com)
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General good health provides adequate barriers to bacterial
infiltration, demonstrated by:
Healthy body tissues, skin & mucous membranes
Plentiful supply of leukocytes
Active & positive lifestyle (little/no smoking, alcohol, social
drug use)
Resident bacteria in GI tract & upper respiratory tract: provide resistance to infection.
plays vital role in resisting invasion by other species of
microorganisms capable of producing infection.
Stomach acid is to a degree capable of destroying ingestedbacteria.
Intestinal enzymes also know to provide secondary defense
mechanisms.
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ACQUIRED IMMUNITYT lymphocytes
Regulate cell-mediated immunity
Responsible for controlling certain bacterial & viral infections
Responsible mediating graft versus host disease, allograft rejection
and delayed hypersensitivity reactions. Augment the activity of B lymphocytes
B lymphocytes
Primarily involved w/ humoral immunity & antibody production.
Differentiates into plasma cells that produce antibodies specific to theinvading antigen once an antigen is introduced into the body.
Antibodies/Immunoglobulin
Attaches to the invading antigen & cause its destruction by phagocytes
and the complement system.
Acquired immunity
-Immunity acquired by
infection or vaccination or by
the transfer of antibody orlymphocytes from an
immune donor.
(www.medicineNet.com)
Structure of an antigen binding fragment of an antibody
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T & B lymphocytes
Once exposed to an antigen demonstrate memory that allows
them to recognize & respond to a specific antigen when exposed
again.
The memory of an antigen by the immune system- allows sensitized
individuals to resist infections on subsequent exposure.
The second response is far greater in magnitude to the first
immunologic response.
Acquired immunity is a specific immunity that may
be:
1) ACTIVE
2) PASSIVE
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1) ACTIVE IMMUNITY Develops in response to antigenic substances in the body.
It is long-lasting, and sometimes life-long.
results when exposure to a disease organism triggers the
immune system to produce antibodies to that disease.
Exposure to the disease organism can occur through
infection with the actual disease (resulting in naturalimmunity)
introduction of a killed or weakened form of the disease
organism through vaccination (vaccine-induced immunity).
Either way, if an immune person comes into contact with thatdisease in the future, their immune system will recognize it andimmediately produce the antibodies needed to fight it.
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2 Classification:
a) Naturally acquired active immunity-occurred by natural means
b) Artificially acquired active immunity
-developed in response toadministration of a specific
vaccine/ toxoid.
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VACCINESAdministered for prophylactic action to develop acquired
active immunity.
May contain living attenuated (weakened)/ killed
microorganisms or fraction of these microorganisms.
TOXOIDS Bacterial toxins modified & detoxified w/ moderate heat
& chemical treatment so that antigenic properties
remain while the substance is rendered nontoxic.Do not cause disease.
Exposure of immuno-competent persons may result in
antibody production that will protect the person against
disease cause by the natural toxin.Measles Mumps Rubella Vaccine
Diphtheria toxoidTetanus toxoid - acellular Pertussis-Containing
Vaccines
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Disadvantages of Toxoids:
they produce inadequate immunologic
responses when administered alone.
Remedy: they are often combined w/
adjuvants that enhance their antigenicity.Adjuvants (Alum, Aluminum
phosphate, Aluminum hydroxide) insoluble in nature. acts to keep the immunogens in tissue for
longer periods thus prolongs immune
response.
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Inactivated Vaccine Attenuated Vaccine
Vaccine composed of killed whole
bacteria/viruses/substructures ofthese.
Must be administered again over
time to maintain adequate
antibody titers.
Vaccines that contain live but
significantly weakenedmicroorganisms.
Typically have more
antigenicity so are more likely
to confer permanent
immunity.
BOTH TYPES- capable of producingimmunity.
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Live Vaccine: caution must be exercised w/
IMMUNOCOMPROMISED PATIENTS.
-patient w/ HIV infection
Thymic abnormalities
Lymphoma
Leukemia Generalized malignancy
Advanced debilitating diseases
Receives corticosteroids, alkylating agents, antimetabolites,
radiation chemotherapy-patients unable to mount immune responses against even
weakened microorganisms in w/c the result could be a
disseminated bacterial/viral infection thus Inactivated
vaccines should be employed.
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Immunization during Pregnancy
Live Attenuated Vaccines: should be avoided
for pregnant patients because of the dangerof transmission of the microorganisms to
the fetus.
ex.
-Measles, mumps & rubella (MMR) vaccine: should
not be administered during pregnancy.-Pregnancy should be avoided for 1 month ff.
vaccination w/monovalent measles vaccine & 4
weeks ff. MMR/other rubella-containing vaccines.
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2) PASSIVE IMMUNITY Occurs by introducing immunoglobulin produced in another
individual (human/animal) into the host who is not involved in their
production.
provided when a person is givenantibodies to a disease rather than
producing them through his or her own immune system.
A newborn baby acquires passive immunity from its mother through the placenta.
A person can also get passive immunity through antibody-containing blood products
such as immune globulin, which may be given when immediate protection from a
specific disease is needed.
Major advantage to passive immunity- protection is immediate, whereas active
immunity takes time (usually several weeks) to develop.
However, passive immunity lasts only for a few weeks or months. Only active immunity
is long-lasting.
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2 Classification:
a) Naturally acquired passive immunity- occurs by placental transmission of immunoglobulin gamma
(IgG) from the mother to the fetus.Thus resulting of infant having passive immunity to diphtheria, tetanus, measles,
mumps & other infections for the first 4-6 months of life.
- transient and relatively short-lived.
b)Artificially acquired passive immunity- occurs when an individual receives antibodies (injections of
gamma globulin) or immune cells (leukocyte transfusions or bonemarrow transplants) from another individual (who had exposure
to a specific antigen)
- transient and relatively short-lived (gamma globulin injections or
leukocyte transfusions) or permanent (bone marrow transplants).
Immunoglobulin G (IgG)
-the most abundant type of
antibody.
-found in all body fluids.-protects against bacterial
and viral infections.
(www.kidshealth.org)
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Immunoglobulin contained in biologic products:
limited to provision of temporary prophylaxis to
susceptible individuals .
provides passive immunity.
Acquired passive immunity provided by immunoglobulin:
Not long lasting usually 1-2 weeks
-because function is to bind to the pathogen as needed.
Important feature: they offer the susceptible patient
protection during a critical period of exposure.
Immunoglobulin- metabolized by the body if not needed
for immunologic purposes.
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Notable in this category:
Anti-venin for treatment of snakebite
(ex. North American coral snake
antivenin)
Anti-venin for treatment of spiders
(ex. Black Widow spider antivenin)
Natural Immunity Acquired Immunity
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Natural Immunity Acquired ImmunityAny immune response which develops as a result of an
individual's exposure to a specific antigen encountered in the
external environment without the intervention of medical
therapy or practice.
Any immune response which develops as a result of an
individual's exposure to a specific antigen encountered due to
the intervention of medical therapy or practice.
Active
Immunity
Passive
ImmunityAny immune response which
develops as a result of an
individual's exposure to a
specific antigen in which the
response is the product of
the individual's own immune
system becoming activated,
generally through the
generation of clones of
antigen-specific B and T
lymphocytes.
Any immune response
which develops as a result
of an individual receiving
immune molecules
(injections of gamma
globulin) or immune cells
(leukocyte transfusions or
bone marrow transplants)
transferred from another
individual (who had had
exposure to a specific
antigen) and, therefore, the
response is not the product
of the individual's own
immune system becoming
activated.
Species
Immunity
Racial
Immunity
Individual
Immunity
Aform of natural
immunity shared
by all members of
a species.
A form of natural
immunity shared
by most of the
members of a
genetically related
population.
A form of natural
immunity not
shared by most
other members
of the race and
species.
It is rare and
probably occursas the result of
an infection that
was not
recognized when
it occurred.
NATURAL ARTIFICIAL
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NATURAL ARTIFICIAL
ACTIVE
Natural active immunity occurs when a
person develops immunity as a result of
exposure to disease organisms or foreign
toxins, venoms, allergens or drugs; generally,
on initial exposure, the person develops the
disease or has an initial negative response to
the toxin or venom.
Artificial active immunity occurs when a
person develops immunity as a result of
exposure to a vaccine designed to protect
against disease organisms or foreign
toxins, venoms, or allergens; generally, on
initial exposure, the person does not
develop symptoms of the disease or has
only minimal response to the toxin or
venom.
PASSIVE
Passive active immunity occurs when amother transmits her own antibodies to her
fetus across the placenta or to her infant in her
milk; such immunity is transient and relatively
short-lived.
Passive artificial immunity occurs whenan individual receives antibodies
(injections of gamma globulin) or immune
cells (leukocyte transfusions or bone
marrow transplants) from another
individual (who had had exposure to a
specific antigen); such immunity may be
transient and relatively short-lived
(gamma globulin injections or leukocyte
transfusions) or it may be permanent
(bone marrow transplants).
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Production of
Biologics,Storage, handling andshipping
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Production of Biologics Produced by manufacturers
licensed to do so in accordancewith the terms of the federal
Public Health Service Act (58Stat. 682) approved July 1, 1944 Each product must meet
specified standards asadministered by the Center forBiologics Evaluation and
Research of the FDA
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Each lot of a licensed biologicis approved for distributionwhen it has determined thatthe lot meets the control
requirements of the product. Licensing includes approval
of a specific series ofproduction steps and in-process control tests as wellas end product specifications
that must be met lot by lot.
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Provisions applicable to biologic
products include: Test for potency General safety Sterility Purity Water (residual moisture) Identity and constituent materials Additional safety test on live
vaccines and certain other items
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Constituent materials include:
Preservatives
Diluents
Adjuvants Extraneous protein in cell-cultured
vaccines
Antibiotics other than penicillinadded to the production substrate ofviral vaccines
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Production of Biologics Packaged and labeled in the same
manner as other injections
Label of the product must includethose mentioned in the next slide.
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Label of he product must
include:
Title or proper name
Name
Address License number of the manufacturer
Lot number
Expiration date Recommended individual dose for
multiple containers
P k l b l l
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Package label must also
include: The preservative and its amount Number of containers Amount of product in the container
The recommended storage temperature A statement (if necessary), that freezing
is to be avoided Other information as FDA regulations
may require
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Storage Most biologics are stored in a refrigerator
(2C to 8C or 35F to 46F)
Freezing is avoided
Diluents packaged with biologics shouldnot be frozen
Some products are to be held at specified
temperatures during shipment
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Expiration date Varies with the product and the
storage temperature
Most have an expiration of a year orlonger after the date of manufactureor issue
Stated date on each lot determinesdating period
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Dating Period Begins on the date of manufacture and
beyond which the product cannot beexpected to retain the required safety,
purity, and potency May be compromised of an in-house
storage period
Individual monographs for biologicsindicate both, the after-issue time framefor use and the permissible in-housestorage period
St H dli d
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Storage, Handling, andShipping of Biologics
Biologics are sensitive to
extreme temperatures Exposure to heat or freezing
can decrease potency andreduce effectiveness
D f d i i t ti f
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Dangers of administration of
damaged products Person may get little or none of the
intended benefit
Person may not be able to build upimmunity
May result in an infection or
inadequate protection from disease
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The overriding theme for apharmacist in storage,
handling, and shipping is tomaintain the cold chain.
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Key ingredient is good
storage equipment.
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Tips Separate commercial
refrigerators
Freezers are used for biologics
Frost-free freezers should beused
Defrosting requires that productmust be temporarily removed instorage.
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Cool air must have room to circulate
WHO recommends that the door may notbe opened frequently than 4 times per
day. Doors should be closed quickly as
possible.
Pharmacists should avoid storing at therefrigerator door
Vaccines should be stored in the top or in
the bottom shelves of the refrigerator
Guidelines
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If vaccines must be kept
outside of the refrigerator fora few minutes, it is advisableto put the product in an
insulated container withcoolant packs from the freezer Freezer packs provide extra
insulation and cooling powerin the freezer.
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Coolant Packs Have cooling capacity of ethylene
glycol
Product must not come in directcontact with these because the vialcontents may freeze and be
damaged.
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Storage Monitoring Advisable to the pharmacist to check the
temperature twice a day as recommended byThe National Immunization Program (NIP)
Temperature logs should be kept for 3 years
Refrigerator temperature: 2C - 8C
Freezer temperature: Below 0C
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Pharmacists should Educate and train very perosn who will
handle bioloics in good storage and
handling procedures.
Store containers of the same vaccine
together
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Centers for
Disease andControl
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BIOLOGICS FOR ACTIVE IMMUNITY
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Vaccine
a suspension of attenuated (live) orinactivated (killed) microorganisms thatare administered to induce immunity and
prevent diseases.
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A. Bacterial Vaccines
The organism is grown in a suitablemedium in a controlled environment oftemperature, pH and oxygen tension.
To reduce hypersensitivity reactions ofproducts, it should consist chemicallydefined ingredients.
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The culture is processed in 2 steps:
1. The organisms are treated with phenolor formaldehyde if the vaccine is to be
inactivated microorganisms.
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Heat and Phenol or heat and acetone employed for typhoid vaccine
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2. The organisms are separated from the
medium through centrifugation andsuspended in sterile H2O or 0.9% NaCl for
injection.
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Live attenuated vaccines:
- produced by genetic alteration ofpathogenic organisms
- this allows organisms to multiply but not
produce the disease
- several base pairs of DNA are altered
- organisms are incapable of reverting to itsmore pathogenic form
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Another way of creating a vaccine is toemploy purified antigen subunits producedby using recombinant DNA.
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Subunit vaccines:
- no potential to harm the patient- has a lower incident of side effects
Example: Hepatitis B vaccine made by
recombinant DNA and hepatitis B surfaceantigen (HBsAg)
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Subunit vaccines:- have no sufficient immune response
Strategies to enhance immune response ofsubunit vaccines:1. May contain single or multiple immunogens
to promote immunity against the same
disease stateExample: MMR (with 3 immunogens)
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2. Mixed biologic may contain vaccine and
toxoid at the same productExample: Pediarix (diptheria, tetanus
toxoids, acellular pertussis, hepatitis B and
poliovirus vaccine)
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The strength of vaccines may be expressed in:- Total number of organisms- Total protective units per milliliter or dose- Micrograms of immunogen in each milliliter or
dose
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B. Viral Vaccines
Viruses cannot be grown on inanimatemedia to grow bacteria
Examples of animate media:
- embryonic egg, cell cultures of chickembryo, human diploid cell culture,monkey cell culture skin of calves and
intact mice
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Techniques to separate the virus from host cell:1. Purification steps to reduce hypersensitivty reactions2. May contain single or mutiple immunogens to elicit
immunity against same disease3. May remain a a whole virion or further chemicall
processed to split into subvirionExample: Influenza Virus Vaccine (influenza A H1N1,
influenza A H3N2 and influenza B)
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Communities may experience outbreaks with
more than on strain of influenza in a year.
Strains are selected during February because ofscheduling requirements for production, qualitycontrol , packaging, distribution and administrationbefore the onset of next influenza season.
To prolong stimulation of antibodies, the virion may be
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p g , yabsorbed onto aluminum phosphateExample: Rabies Vaccine
Viral vaccines are available as:1. Lyophilized products that require reconstitution2. Inactivated Vaccines in suspensions for injection
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The strength of Viral vaccines can be provided in:
1. Tissue culture infectious doses2. The quantity of virus estimated to infect 50% of inoculatedcultures
Employed in viral vaccines are:
1. Micrograms of immunogen2. D-antigen units3. International units4. Plaque-unit forming for yellow fever vaccine
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C. Cancer Vaccines
Cancer vaccines in development areintended to increase recognition of cancercells by immune system.
These vaccines also play a role inpreventing cancer patients at high riskbecause of familial diseases.
For the immune system to recognize and kill a
tumor cell, it must recognize antigents on thetumor cells.
Tumor killing cells recognize Tumor
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Tumor-killing cells recognize Tumor-Associated Antigens (TAAs)
TAAs fall into 3 categories:1. Patient specific - antigens unique to a
specific patient
Example: antigen on B-cell malignancy2. Tumor specific unique to a particular tumor
Example: prostate-specific antigen
3. Shared
created by tumor cells withcommon histology
Example: carcinoembryonic antigen
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Four Types of Cancer Vaccines
1. Autologous tumor vaccines- Developed from antigenic material
procured from the tumor of the patient
- Tumor cells are isolated during biopsy- These cells are killed or infused into the
patients
- To enhance immunogenicity, they arecombined with bacille Calmette-Guerin orC paravuum
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2. Allogeneic tumor vaccines- produced from cell lines that express tumor-
specific or shared TAAs- to induce an immune response, either thefragment or whole tumor cell is injected
3. Anti-idiotypic vaccines- are 3 dimensional immunogenic regions on theantibody that binds antigen- the anti-idiotypic antibody closely resembles the
antigen which can be used to induce immuneresponses to a given antigen
4 Gene therapy
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4. Gene therapy- allows a DNA template to be placed within a cell,transcribed into mRNA and expressed as a
costimulatory protein
Example: Quadrivalent Human PapillomavirusRecombinant Vaccine (used to prevent vaginalcancers)
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D. Toxoids
Process of Toxoids:
Bacteria are propagated Culture is filtered
through a sterilizing membrane filter
filtrate is added with salt solution toprecipitate toxin purify toxin toxin is
detoxified with formaldehyde
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Detoxified Toxin may be:1.Plain or with adjuvants2. May contain single, multiple or mixed
immunogens
Strength of a toxoid:- In flocculating units (Lf)Flocculating unit smallest amount of toxin that
flocculates most rapidly one unit of standard
antitoxin in a series of mixtures containing fixedamounts of antitoxin
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BIOLOGICS FOR PASSIVE
IMMUNITY
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HUMAN IMMUNE SERA ANDGLOBULINS
(HOMOLOGOUS SERA)
HUMAN IMMUNE SERA AND
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HUMAN IMMUNE SERA AND
GLOBULINS (HOMOLOGOUS SERA)
Include immunoglobulin and hyperimmune serafor specific diseases Contain antibodies obtained from human blood, and
produced as a result of having had the specific disease
or having been immunized against it with a specificbiologic product
Source: pooled plasma from adult donors (thusconfer passive immunity) From the general population: for immunoglobulin
From hyperimmunized donors: for immunoglobulinsfor specific diseases
HUMAN IMMUNE SERA AND
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HUMAN IMMUNE SERA AND
GLOBULINS (HOMOLOGOUS SERA)
Pooled plasma from adult donors: Must be free of hepatitis B antigen and antibodies to
HIV
Processing steps:
Fractional Precipitation (e.g. with cold ethanol) Maintaining rigorous control of pH
Ionic strength
Further purification of finished product
For intramuscular injection: biologic productmust contain N.L.T. 15% and N.M.T. 18% protein
For intravenous injection: immunoglobulinintravenous (3% to 6% protein) andcytomegalovirus immunoglobulin
HUMAN IMMUNE SERA AND
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HUMAN IMMUNE SERA AND
GLOBULINS (HOMOLOGOUS SERA)
Sera
Greatest value for the treatment of acute disease
Useful in some instances to prevent illness when
immediate protection is needed
Immune serum
Gives brief immunity because the foreign serum
and the antibodies it produces are eliminatedfrom the body within a few weeks
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ANIMAL IMMUNE SERA
(HETEROLOGOUS SERA)
ANIMAL IMMUNE SERA
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ANIMAL IMMUNE SERA
(HETEROLOGOUS SERA)
Most commonly employed immune sera:prepared by immunization of horses againstthe specific immunogen
After the plasma is harvested, it is separatedby fractional precipitation into:
Immunologically active components(immunoglobulins)
Treated with pepsin to remove the complement-activating component of the molecules and render itless immunogenic. The active component is recoveredthrough dialysis and fractional precipitation orcentrifugation
ANIMAL IMMUNE SERA
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ANIMAL IMMUNE SERA
(HETEROLOGOUS SERA)
Antitoxins Produced by inoculating horses with increasing doses
of the toxoids and exotoxins. The animal is bled withadequate safeguards after several injections overweeks/months to avoid contamination and the plasmaharvested
Antivenins Produced by inoculating horses with the venom of
selected species and harvesting the plasma
A sensitivity test with suitable controls should betaken to detect any dangerous hypersensitivitybefore using these products to ensure the safetyof the patient who may be sensitive to horse
protein
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EXAPLES OF OFFICIAL BIOLOGICPRODUCTS
TABLE 16.1 (pgs. 502-504)
VACCINES AND VACCINE
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VACCINES AND VACCINE
COMBINATIONS
BIOLOGIC PRODUCT ROUTE USE
Anthrax adsorbed SQ Active immunizing agent
BCG ID Active immunizing agent
Hepatitis B IM Active immunizing agent
Human Papilloma Virus IM Active immunizing agent
Influenza virus
IM Active immunizing agent
IN Active immunizing agent
Measles virus, live SQ Active immunizing agent
Measles, mumps, rubella virus, live SQ Active immunizing agent
Measles, mumps, rubella, varicella
virus, liveSQ Active immunizing agent
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VACCINES AND VACCINE
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VACCINES AND VACCINE
COMBINATIONS
BIOLOGIC PRODUCT ROUTE USE
Measles, rubella virus, live SQ Active immunizing agent
Mumps virus, live SQ Active immunizing agent
Pneumococcal, polyvalent IM, SQ Active immunizing agent
Pneumococcal 7-valent conjugate IM Active immunizing agent
Rabies
HDCV, IMD, ID; RDCV, IM Active immunizing agent
IN Active immunizing agent
Rubella virus, live SQ Active immunizing agent
Rubella and mumps, live SQ Active immunizing agent
Smallpox ID Active immunizing agent
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VACCINES AND VACCINE
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VACCIN S AN VACCIN
COMBINATIONS
BIOLOGIC PRODUCT ROUTE USE
Typhoid SQ or ID; oral Active immunizing agent
Varicella virus, live SQ Active immunizing agent
Yellow fever SQ Active immunizing agent
Zoster virus, live SQ Active immunizing agent
TOXOIDS
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TOXOIDS
BIOLOGIC PRODUCT ROUTE USE
Diphtheria and tetanus, adsorbed Deep IM Active immunizing agent
Tetanus IM, SQ Active immunizing agent
Tetanus, adsorbed Deep IM Active immunizing agent
Tetanus, diphtheria adsorbed for
adult useIM Active immunizing agent
ANTITOXINS
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ANTITOXINS
BIOLOGIC PRODUCT ROUTE USE
Botulism IM or IV Passive immunizing agent
TetanusIM or SQ (prophylactic) or IV
(therapeutic)Passive immunizing agent
IMMUNE SERA
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IMMUNE SERA
BIOLOGIC PRODUCT ROUTE USE
Cytomegalovirus IV
Passive for kidney transplant
recipients seronegative for CMV who
receive kidney from CMV seropositive
donor
Immunoglobulin IM IM
Passive immunity to hepatitis A and
B, measles, varicella zoster, primary
immunodeficiency diseases
Immunoglobulin IV IV
Primary immunodeficiency diseases,
HIV, ITP, bone marrow transplant,
beta cell CLL
Rho (D) globulin IM Passive immunizing agent
Tetanus immunoglobulin IM Passive immunizing agent
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MISCELLANEOUS BIOLOGIC PRODUCTS
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MISCELLANEOUS BIOLOGIC PRODUCTS
BIOLOGIC PRODUCT ROUTE USE
Antivenin (Crotalidae) Polyvalent IM or IVNeutralizes venom of crotalids native
to the Americas
Candida albicans skin test antigen IDDetects reduced cellularhypersensitivity, DTH; assesses
diminished cellular immunity in HIV
Histoplasmin, USP ID Diagnostic aid (histoplasmosis)
Plasma Protein Fraction, USP IV Blood-volume expansion
Tuberculin, USP ID Diagnostic aid (tuberculosis)
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