NAPSR CNPR CHAPTER 12
BIOPHARMACEUTICAL DRUG
DEVELOPMENT EXAM QUESTIONS &
ANSWERS RATED 100% CORRECT
small molecule drugs - correct answer ✔✔pharmaceuticals; new chemical entities (NCE's) that
are produced in manufacturing plants using techniques based on chemical reactions to
reactants.
large molecule drugs - correct answer ✔✔biopharmaceuticals; mainly protein based and
resemble natural biological compounds found in the human body. Manufactured in biological
systems such as living cells. these resemble the body's naturally occurring proteins, usually
more potent than any other disease treatments.
3 uses biopharmaceuticals are developed for - correct answer ✔✔prophylactic (preventative)
therapeutic (antibodies) replacement therapy (hormones; growth factors)
biologics - correct answer ✔✔a biological product subject to licensure under the Public Health
Service Act that is applicable to the prevention, treatment, or cure of disease or injuries to
humans. Vaccines, antibodies, cytokines, hormones, gene therapy, stem cells
vaccines - correct answer ✔✔an antigen that has been treated to stimulate the immune system
and cause antibodies to be secreted to react against the foreign antigen.
pathogen - correct answer ✔✔include mainly viruses, bacteria, parasites and fungi
virulent part - correct answer ✔✔the part of a pathogen that causes disease
, traditional vaccine preparation - correct answer ✔✔3 ways: attenuated vaccines, killed or
inactivated vaccines, toxoids
passaging - correct answer ✔✔growing the pathogen in species other than the natural host
attenuated vaccine advantages - correct answer ✔✔less expensive preparation, one dose
sufficient, attract the desired immunological response
attenuated vaccine disadvantages - correct answer ✔✔potentially revert to virtulence, limited
shelf life
killed or inactivated vaccines - correct answer ✔✔chemical or temperature treatments are
normally used to kill or inactivate a pathogen. formaldehyde, phenol, acetone or irradiation.
advantages of inactivated vaccines - correct answer ✔✔non-reversal to virtulance, stable shelf
life
disadvantages of inactivated vaccines - correct answer ✔✔higher production costs, more
controlled production, booster vaccines needed
toxoid - correct answer ✔✔derived from toxins secreted by a pathogen.
subunit vaccine - correct answer ✔✔uses only a part of the bacteria or virus rather than the
whole pathogen
epitopes - correct answer ✔✔novel antigenic surface proteins that bind to antibodies
BIOPHARMACEUTICAL DRUG
DEVELOPMENT EXAM QUESTIONS &
ANSWERS RATED 100% CORRECT
small molecule drugs - correct answer ✔✔pharmaceuticals; new chemical entities (NCE's) that
are produced in manufacturing plants using techniques based on chemical reactions to
reactants.
large molecule drugs - correct answer ✔✔biopharmaceuticals; mainly protein based and
resemble natural biological compounds found in the human body. Manufactured in biological
systems such as living cells. these resemble the body's naturally occurring proteins, usually
more potent than any other disease treatments.
3 uses biopharmaceuticals are developed for - correct answer ✔✔prophylactic (preventative)
therapeutic (antibodies) replacement therapy (hormones; growth factors)
biologics - correct answer ✔✔a biological product subject to licensure under the Public Health
Service Act that is applicable to the prevention, treatment, or cure of disease or injuries to
humans. Vaccines, antibodies, cytokines, hormones, gene therapy, stem cells
vaccines - correct answer ✔✔an antigen that has been treated to stimulate the immune system
and cause antibodies to be secreted to react against the foreign antigen.
pathogen - correct answer ✔✔include mainly viruses, bacteria, parasites and fungi
virulent part - correct answer ✔✔the part of a pathogen that causes disease
, traditional vaccine preparation - correct answer ✔✔3 ways: attenuated vaccines, killed or
inactivated vaccines, toxoids
passaging - correct answer ✔✔growing the pathogen in species other than the natural host
attenuated vaccine advantages - correct answer ✔✔less expensive preparation, one dose
sufficient, attract the desired immunological response
attenuated vaccine disadvantages - correct answer ✔✔potentially revert to virtulence, limited
shelf life
killed or inactivated vaccines - correct answer ✔✔chemical or temperature treatments are
normally used to kill or inactivate a pathogen. formaldehyde, phenol, acetone or irradiation.
advantages of inactivated vaccines - correct answer ✔✔non-reversal to virtulance, stable shelf
life
disadvantages of inactivated vaccines - correct answer ✔✔higher production costs, more
controlled production, booster vaccines needed
toxoid - correct answer ✔✔derived from toxins secreted by a pathogen.
subunit vaccine - correct answer ✔✔uses only a part of the bacteria or virus rather than the
whole pathogen
epitopes - correct answer ✔✔novel antigenic surface proteins that bind to antibodies
