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CNPR,NAPSR EXAM QUESTIONS AND ANSWERS A+ GRADED
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CNPR,NAPSR EXAM QUESTIONS ANDANSWERS A+ GRADED
Drug Discovery - ANSWER • Unlike small molecule drugs (pharmaceuticals), large
molecule drugs (biopharmaceuticals) are mainly protein-based
o These protein-based drugs are similar to natural biological compounds found in
human body or they're fragments that mimic active part of natural compounds
Discovery of Pharmaceuticals - ANSWER starts w/ scanning hundreds of compounds,
whether w/ actual materials (irrational approach) or virtual simulations (rational
approach)
• Pharmaceuticals are new chemical entities NCEs and are produced synthesized in
manufacturing plants using techniques based upon chemical reactions of reactants
Discovery of Biopharmaceuticals - ANSWER researchers must study compounds w/in
humans
o Ex. Hormones or other biological response modifiers and their effects on biological
processes
o In some instances, investigate pathogens such as the influenza virus or bacteria to
obtain vaccines
o In other cases, researchers copy these biological response modifiers and use them as
replacement therapy
o Protein-based drugs are manufactured in biological systems, such as living cells,
producing desired protein molecules in large reaction vessels or by extraction from
animal serum
o Becoming increasingly important
• More potent and specific—more similar to proteins w/in body therefore more effective
in treating our diseases
Areas of Biopharmaceuticals - ANSWER • Prophylactic→ preventive as in vaccines
,• Therapeutic→ antibodies
• Replacement therapy→ hormones, growth factors
Biologics - ANSWER FDA definition is:
o Biologic product subject to licensure under Public Health Service Act is any virus,
therapeutic serum, toxin, antitoxin, vaccine, blood, a blood component or derivative,
allergenic produce, or analogous product, applicable to prevention, treatment or cure
of diseases or injuries to humans. These include, but are not limited to, bacterial and
viral vaccines, human blood and plasma and their derivatives, and certain
biotechnology products such as interferons and erythropoietins. Many biologics are
protein-based medicines, and there are blood products that may be prepared from
blood, such as clotting factors.
Vaccination- ANSWER • The principle of vaccination is that the administration of a small
amount of a vaccine, that is an antigen that has been treated, stimulates our immune
system and causes antibodies to be produced to react against the foreign antigen. •
Later in life, if we are exposed again to the same antigen, then our immune system will
elicit a memory response and allow the defense mechanisms to be turned on and
antibodies developed to fight the invading antigen.
• Contains antigenic components that are obtained from or derived from pathogen
o Include mainly viruses, bacteria, parasites and fungi
o Research has shown that part of pathogen that causes disease (virulence) can be
decoupled from protective part (immunity)
• Development focuses on means to reduce virulence factor while retaining immunity
stimulation
• Oral or parenteral
Vaccine Preparations - ANSWER Attenuated Vaccines
Killed or Inactivated Vaccines
Toxoids
Attenuated Vaccines - ANSWER • The virulence of the pathogen can be reduced in
several ways, such as • By chemical treatment, by temperature adaptation or by
,growing the pathogen in a specified other than natural host (passaging), advantages are
• Low cost preparation, elicit desired immunological response and normally single dose
is sufficient. • Disadvantages are • A potential to revert to virulence and • Limited shelf
life
Killed or Inactivated Vaccines - ANSWER • Killing or inactivation of the pathogen is
usually done by chemical and temperature treatment. • Treatment with formaldehyde is
most common. • Other chemicals used are phenol and acetone. • Irradiation of the
pathogen is another method to render it inactive. • Advantages are that it is
nonreversible into virulence and have relatively stable shelf life.
• More expensive to produce, greater control required in production to assure reliable
processes for complete inactivation, may need multiple booster vaccinations since
treatment processes may result in reduced immunological response
Toxoids - ANSWER • result from toxins produced by the pathogen
• Advantages and disadvantages are similar to killed/inactivated vaccines. Advantages
of non-reversal to virulence and relatively stable, disadvantages include higher cost of
production and more control is required for production to ensure processes reliable to
ensure complete inactivation. Reduced immunological response possible as a result of
treatment processes hence multiple booster vaccinations may be required.
New Vaccines - ANSWER • Advances in genomics, molecular biology and recombinant
technology has provided new directions for discovery, development and manufacture of
vaccines
• Current approach is minimalist strategy to decouple virulence and immunity functions
• Aim is to use only immunity part to confer protection, so vaccine is safe to be
administered
• Approach can be divided into subunit, vector-based, DNA and peptide vaccines
Subunit Vaccines - ANSWER • Use only part of bacteria or virus instead of entire
pathogen Part is derived from outside envelope protein of pathogen Requires
knowledge of genome sequence of pathogen by identifying open reading frames (ORF)
that potentially encode novel antigenic surface proteins known as epitopes, which bind
to antibodies When identified, ORFs cloned to express protein epitopes using
self-replicating plasmids
, It is possible to study the binding properties of the epitope using techniques such as
ELISA or FACS. The most promising epitope candidates are injected into animals to test
for antibody responses. o Those that work are affinity matured and optimized into
vaccine candidates, with the possibility of further tests before human clinical trials. o
Also working on multiple epitope subunit vaccines to provide different antigenic binding
sites
Vector-based Vaccines - ANSWER • The viruses and bacteria are detoxified to be used
as vehicles carrying vaccines • Subunit vaccines are supplied by carrier vehicle, which
acts to induce immune response • More than one type of envelope proteins can be
supplied with this technique • This type of vector-based vaccine is being studied in
clinical trials
DNA Vaccines - ANSWER • Also known as nucleic vaccines or genetic immunization
• Host is directly injected w/ selected viral genes that are engineered to contain DNA
sequences encoding for antigens • Hosts cells take up these genes, express antigens
presented to immune cells, and stimulate immune response Peptide Vaccines -
ANSWER • Chemically synthesized. Typically 8-24 amino acids in length • Generally
small • Also referred to as peptidomimetic vaccines due to their ability to mimic epitopes
• The peptide chain can be built into cyclic components, branched chain, or other
configurations of complex structures. • They have conformation similar to epitopes and
thus can be recognized by immune cells. • Potential epitopes were searched using in
silico vaccine design approach. • 3D structures similar to native epitopes of the
pathogen is the most crucial aspect to be produced in peptide vaccines.
Adjuvant - ANSWER • Vaccines formulated w/ certain substances to enhance immune
response
• Latin adjuvare→ to help
• Most common adjuvants for humans are aluminum hydroxide, aluminum phosphate and
calcium phosphate
• Others include bacteria and cholesterol
• Mineral oil emulsions normally adjuvants used in animal studies
• Adjuvant known as Freund's Complete Adjuvant consists of killed tubercle bacilli in
water-in-mineral oil emulsion
• Freund's Incomplete Adjuvant is water-in-oil emulsion
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