BTEC 3320 Exam 3 Quizzes 6-13
Questions With Complete Solution.
"During bioprocess, the temperature sensors (probes) are dipped in the fermentation
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culture inside the bioreactor, signal from the sensors read by a computer, and the
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temperature of the heating blanket gets automatically adjusted. The temperature
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measurement by the sensor is an example of:"
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a) In-line measurement
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b) Non-invasive measurement
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c) On-line measurement
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d) At-line measurement
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e) Out-of-line measurement - (correct answer) -a) In-line measurement
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What does not apply to specifications for release of finish drug products?
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a) Acceptance criteria should be changed if test results don't conform to specifications
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b) Many analytical procedures that are part of specifications are found in the US
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Pharmacopeia
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c) Specifications consist of test procedures
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d) Release specifications are approved by regulatory agency as conditions for marketing
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approval
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e) Specifications include rejection criteria for certain attributes - (correct answer) -a)
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Acceptance criteria should be changed if test results don't conform to specifications
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"In the Genzyme video on producing biotherapeutics using mammalian cells, what is the
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correct sequence of manufacturing activities in the 90-day production flow?"
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a) "Thaw frozen cell bank, small-scale growth, large-scale growth, harvesting, filtration,
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chromatographic purification, fill and finish"
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b) "Thaw frozen cell bank, large-scale growth, small-scale growth, production, harvest,
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filtration, chromatographic purification, fill and finish"
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c) "Thaw frozen cell bank, small-scale growth, large-scale growth, fill and finish, harvest,
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filtration, chromatographic purification"
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d) "Thaw frozen cell bank, small-scale growth, large-scale growth, chromatographic
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purification, harvest, fill and finish"
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e) "Small-scale growth, large-scale growth, production, harvest, chromatographic
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purification, fill and finish, thaw frozen cell bank" - (correct answer) -a) "Thaw frozen cell
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bank, small-scale growth, large-scale growth, harvesting, filtration, chromatographic
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purification, fill and finish"
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"In the sampling table shown in slide 35, for a lot size of 660, ______________ units should
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be obtained and tested for conformance to specifications."
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a) 32 units
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b) 125 units
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,c) 200 units
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d) 315 units
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e) 50 units - (correct answer) -a) 32 units
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What is not a main job responsibility of the QC group?
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a) Checking adherence of process technician to batch record SOPs
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b) Analytical testing of raw materials against specifications before use by the production
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group
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c) Testing of drug products against specifications before release
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c) Provide analytical support for process validation and in-process tests
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e) Environmental monitoring for viables and non-viables - (correct answer) -a) Checking
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adherence of process technician to batch record SOPs
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"In the manufacturing of small molecule drugs, what would be considered as an impurity
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rather than a contaminant?"
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a) incompletely synthesized API
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b) equipment lubricants
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c) microbes
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d) endotoxins
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e) dust particles
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f) An inorganic catalyst - (correct answer) -a) incompletely synthesized API
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What is not always a requirement for cGMP-compliant sampling?
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a) Samples must be stored at low temperatures
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b) "Sampling plans and methods must be written, defined, and pre-approved"
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c) Samples must accurately portray the quality attributes of a drug product lot
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d) Sampling plans must be based on appropriate statistical criteria
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e) Samples obtained must be properly identified and handled - (correct answer) -a)
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Samples must be stored at low temperatures
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"What is not a source of information on acceptable sampling sizes, like the table shown
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below?"
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a) American Institute for Sampling Compliance
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b) American National Standards Institute
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c) American Society for Quality
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d) Military standard
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e) International Organization for Standardization - (correct answer) -a) American Institute
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for Sampling Compliance
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Which is not an in-process control test used to monitor the progress of protein production
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during fermentation?
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a) Gene copy number
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b) Concentration of biologic
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c) Presence of misfolded proteins
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d) Presence of chemicals used to clean the bioreactor
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e) Endotoxin levels - (correct answer) -a) Gene copy number
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, What does not apply to raw materials or raw material testing?
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a) Full testing against the CofA should be conducted on all raw materials
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b) Criticality of materials and tests differ for different raw materials depending on their
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intended use
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c) "Raw materials must be identified, quarantined, their identity tested by specific assays,
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and released by QC and QA"
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d) "Quality requirements for raw materials are met somewhat differently in production of
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pre-clinical, clinical batches, and manufacturing of licensed products"
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e) "If the raw material is microbiologically sensitive, it may be prudent to sample every
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container regardless of lot size. "
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f) Certificates of Analysis should accompany every lot of delivered raw material - (correct
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answer) -a) Full testing against the CofA should be conducted on all raw materials
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What is not a process control variable in the downstream cell harvesting processes that
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could impact product quality and yield?
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a) Bioreactor cleaning reagents
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b) Filtration backpressure
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c) Filtration temperature
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d) pH of chromatography mobile phase
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e) Centrifugation speed - (correct answer) -a) Bioreactor cleaning reagents
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"45 drums of bulk raw material were delivered to your manufacturing company. As the QC
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analyst assigned to handle the delivered material, what is the minimum number of drums
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that you should sample and test for attributes like impurities or water content? "
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a) 8 drums ji ji
b) 6 drums ji ji
c) 7 drumsji ji
d) 9 drums ji ji
e) 15 drums - (correct answer) -a) 8 drums
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What is not used as a potency assay for antibodies?
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a) "In vitro binding assays, like ELISA"
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b) Cell-based killing
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c) Activation of a reporter gene in cells
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d) Testing activity In animal models
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e) NMR - Nuclear Magnetic Resonance - (correct answer) -e) NMR - Nuclear Magnetic
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Resonance
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What is not a product release test for biologics?
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a) mg antibody per vial of drug product
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b) PCR for viral contaminants
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c) tests for potency
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d) amino acid sequencing of biologic
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e) identity test for the cell substrate - (correct answer) -e) identity test for the cell substrate
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Questions With Complete Solution.
"During bioprocess, the temperature sensors (probes) are dipped in the fermentation
ji ji ji ji ji ji ji ji ji ji
culture inside the bioreactor, signal from the sensors read by a computer, and the
ji ji ji ji ji ji ji ji ji ji ji ji ji ji
temperature of the heating blanket gets automatically adjusted. The temperature
ji ji ji ji ji ji ji ji ji ji
measurement by the sensor is an example of:"
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a) In-line measurement
ji ji
b) Non-invasive measurement
ji ji
c) On-line measurement
ji ji
d) At-line measurement
ji ji
e) Out-of-line measurement - (correct answer) -a) In-line measurement
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What does not apply to specifications for release of finish drug products?
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a) Acceptance criteria should be changed if test results don't conform to specifications
ji ji ji ji ji ji ji ji ji ji ji ji
b) Many analytical procedures that are part of specifications are found in the US
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Pharmacopeia
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c) Specifications consist of test procedures
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d) Release specifications are approved by regulatory agency as conditions for marketing
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approval
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e) Specifications include rejection criteria for certain attributes - (correct answer) -a)
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Acceptance criteria should be changed if test results don't conform to specifications
ji ji ji ji ji ji ji ji ji ji ji ji
"In the Genzyme video on producing biotherapeutics using mammalian cells, what is the
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correct sequence of manufacturing activities in the 90-day production flow?"
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a) "Thaw frozen cell bank, small-scale growth, large-scale growth, harvesting, filtration,
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chromatographic purification, fill and finish"
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b) "Thaw frozen cell bank, large-scale growth, small-scale growth, production, harvest,
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filtration, chromatographic purification, fill and finish"
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c) "Thaw frozen cell bank, small-scale growth, large-scale growth, fill and finish, harvest,
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filtration, chromatographic purification"
ji ji ji
d) "Thaw frozen cell bank, small-scale growth, large-scale growth, chromatographic
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purification, harvest, fill and finish"
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e) "Small-scale growth, large-scale growth, production, harvest, chromatographic
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purification, fill and finish, thaw frozen cell bank" - (correct answer) -a) "Thaw frozen cell
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bank, small-scale growth, large-scale growth, harvesting, filtration, chromatographic
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purification, fill and finish"
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"In the sampling table shown in slide 35, for a lot size of 660, ______________ units should
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be obtained and tested for conformance to specifications."
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a) 32 units
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b) 125 units
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,c) 200 units
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d) 315 units
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e) 50 units - (correct answer) -a) 32 units
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What is not a main job responsibility of the QC group?
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a) Checking adherence of process technician to batch record SOPs
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b) Analytical testing of raw materials against specifications before use by the production
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group
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c) Testing of drug products against specifications before release
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c) Provide analytical support for process validation and in-process tests
ji ji ji ji ji ji ji ji ji
e) Environmental monitoring for viables and non-viables - (correct answer) -a) Checking
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adherence of process technician to batch record SOPs
ji ji ji ji ji ji ji ji
"In the manufacturing of small molecule drugs, what would be considered as an impurity
ji ji ji ji ji ji ji ji ji ji ji ji ji
rather than a contaminant?"
ji ji ji ji
a) incompletely synthesized API
ji ji ji
b) equipment lubricants
ji ji
c) microbes
ji
d) endotoxins
ji
e) dust particles
ji ji
f) An inorganic catalyst - (correct answer) -a) incompletely synthesized API
ji ji ji ji ji ji ji ji ji ji
What is not always a requirement for cGMP-compliant sampling?
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a) Samples must be stored at low temperatures
ji ji ji ji ji ji ji
b) "Sampling plans and methods must be written, defined, and pre-approved"
ji ji ji ji ji ji ji ji ji ji
c) Samples must accurately portray the quality attributes of a drug product lot
ji ji ji ji ji ji ji ji ji ji ji ji
d) Sampling plans must be based on appropriate statistical criteria
ji ji ji ji ji ji ji ji ji
e) Samples obtained must be properly identified and handled - (correct answer) -a)
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Samples must be stored at low temperatures
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"What is not a source of information on acceptable sampling sizes, like the table shown
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below?"
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a) American Institute for Sampling Compliance
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b) American National Standards Institute
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c) American Society for Quality
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d) Military standard
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e) International Organization for Standardization - (correct answer) -a) American Institute
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for Sampling Compliance
ji ji ji
Which is not an in-process control test used to monitor the progress of protein production
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during fermentation?
ji ji
a) Gene copy number
ji ji ji
b) Concentration of biologic
ji ji ji
c) Presence of misfolded proteins
ji ji ji ji
d) Presence of chemicals used to clean the bioreactor
ji ji ji ji ji ji ji ji
e) Endotoxin levels - (correct answer) -a) Gene copy number
ji ji ji ji ji ji ji ji ji
, What does not apply to raw materials or raw material testing?
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a) Full testing against the CofA should be conducted on all raw materials
ji ji ji ji ji ji ji ji ji ji ji ji
b) Criticality of materials and tests differ for different raw materials depending on their
ji ji ji ji ji ji ji ji ji ji ji ji ji
intended use
ji ji
c) "Raw materials must be identified, quarantined, their identity tested by specific assays,
ji ji ji ji ji ji ji ji ji ji ji ji
and released by QC and QA"
ji ji ji ji ji ji
d) "Quality requirements for raw materials are met somewhat differently in production of
ji ji ji ji ji ji ji ji ji ji ji ji
pre-clinical, clinical batches, and manufacturing of licensed products"
ji ji ji ji ji ji ji ji
e) "If the raw material is microbiologically sensitive, it may be prudent to sample every
ji ji ji ji ji ji ji ji ji ji ji ji ji ji
container regardless of lot size. "
ji ji ji ji ji ji
f) Certificates of Analysis should accompany every lot of delivered raw material - (correct
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answer) -a) Full testing against the CofA should be conducted on all raw materials
ji ji ji ji ji ji ji ji ji ji ji ji ji ji
What is not a process control variable in the downstream cell harvesting processes that
ji ji ji ji ji ji ji ji ji ji ji ji ji
could impact product quality and yield?
ji ji ji ji ji ji
a) Bioreactor cleaning reagents
ji ji ji
b) Filtration backpressure
ji ji
c) Filtration temperature
ji ji
d) pH of chromatography mobile phase
ji ji ji ji ji
e) Centrifugation speed - (correct answer) -a) Bioreactor cleaning reagents
ji ji ji ji ji ji ji ji ji
"45 drums of bulk raw material were delivered to your manufacturing company. As the QC
ji ji ji ji ji ji ji ji ji ji ji ji ji ji
analyst assigned to handle the delivered material, what is the minimum number of drums
ji ji ji ji ji ji ji ji ji ji ji ji ji ji
that you should sample and test for attributes like impurities or water content? "
ji ji ji ji ji ji ji ji ji ji ji ji ji ji
a) 8 drums ji ji
b) 6 drums ji ji
c) 7 drumsji ji
d) 9 drums ji ji
e) 15 drums - (correct answer) -a) 8 drums
ji ji ji ji ji ji ji ji
What is not used as a potency assay for antibodies?
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a) "In vitro binding assays, like ELISA"
ji ji ji ji ji ji
b) Cell-based killing
ji ji
c) Activation of a reporter gene in cells
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d) Testing activity In animal models
ji ji ji ji ji
e) NMR - Nuclear Magnetic Resonance - (correct answer) -e) NMR - Nuclear Magnetic
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Resonance
ji
What is not a product release test for biologics?
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a) mg antibody per vial of drug product
ji ji ji ji ji ji ji
b) PCR for viral contaminants
ji ji ji ji
c) tests for potency
ji ji ji
d) amino acid sequencing of biologic
ji ji ji ji ji
e) identity test for the cell substrate - (correct answer) -e) identity test for the cell substrate
ji ji ji ji ji ji ji ji ji ji ji ji ji ji ji ji
