biologics reporting

8/10/2019 Biologics Reporting

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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


shared by most of the members

of a genetically relatedpopulation.

(www.medical-



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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


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-



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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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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



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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



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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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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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COMBINATIONS


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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VACCIN S AN VACCIN

COMBINATIONS


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


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


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


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


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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biologics reporting

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