NAPSR CNPR CHAPTER 12
Biopharmaceutical Drug Development
small molecule drugs - Answer-pharmaceuticals; new chemical entities (NCE's) that are produced in
manufacturing plants using techniques based on chemical reactions to reactants.
large molecule drugs - 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 - Answer-prophylactic (preventative) therapeutic
(antibodies) replacement therapy (hormones; growth factors)
biologics - 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 - 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 - Answer-include mainly viruses, bacteria, parasites and fungi
, virulent part - Answer-the part of a pathogen that causes disease
traditional vaccine preparation - Answer-3 ways: attenuated vaccines, killed or inactivated vaccines,
toxoids
passaging - Answer-growing the pathogen in species other than the natural host
attenuated vaccine advantages - Answer-less expensive preparation, one dose sufficient, attract the
desired immunological response
attenuated vaccine disadvantages - Answer-potentially revert to virtulence, limited shelf life
killed or inactivated vaccines - Answer-chemical or temperature treatments are normally used to kill or
inactivate a pathogen. formaldehyde, phenol, acetone or irradiation.
advantages of inactivated vaccines - Answer-non-reversal to virtulance, stable shelf life
disadvantages of inactivated vaccines - Answer-higher production costs, more controlled production,
booster vaccines needed
toxoid - Answer-derived from toxins secreted by a pathogen.
subunit vaccine - Answer-uses only a part of the bacteria or virus rather than the whole pathogen
epitopes - Answer-novel antigenic surface proteins that bind to antibodies
Biopharmaceutical Drug Development
small molecule drugs - Answer-pharmaceuticals; new chemical entities (NCE's) that are produced in
manufacturing plants using techniques based on chemical reactions to reactants.
large molecule drugs - 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 - Answer-prophylactic (preventative) therapeutic
(antibodies) replacement therapy (hormones; growth factors)
biologics - 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 - 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 - Answer-include mainly viruses, bacteria, parasites and fungi
, virulent part - Answer-the part of a pathogen that causes disease
traditional vaccine preparation - Answer-3 ways: attenuated vaccines, killed or inactivated vaccines,
toxoids
passaging - Answer-growing the pathogen in species other than the natural host
attenuated vaccine advantages - Answer-less expensive preparation, one dose sufficient, attract the
desired immunological response
attenuated vaccine disadvantages - Answer-potentially revert to virtulence, limited shelf life
killed or inactivated vaccines - Answer-chemical or temperature treatments are normally used to kill or
inactivate a pathogen. formaldehyde, phenol, acetone or irradiation.
advantages of inactivated vaccines - Answer-non-reversal to virtulance, stable shelf life
disadvantages of inactivated vaccines - Answer-higher production costs, more controlled production,
booster vaccines needed
toxoid - Answer-derived from toxins secreted by a pathogen.
subunit vaccine - Answer-uses only a part of the bacteria or virus rather than the whole pathogen
epitopes - Answer-novel antigenic surface proteins that bind to antibodies
