BTC exam questions & answers grade A+ 2024/2025
A researcher is working with a protein that contains four subunits of differing molecular weights. If the researcher perfoms native PAGE, how many distinct bands should he see on the gel? - ANSWERSA. four
B. ONE
C. Two
D.Three
_______Is not...
A researcher is working with a protein that contains four subunits of differing molecular weights. If the
researcher perfoms native PAGE, how many distinct bands should he see on the gel? - ANSWERSA. four
B. ONE
C. Two
D.Three
_______Is not used to detect protiens in gel - ANSWERSA. Coomassie Brilliant Blue
B. Silver Stain
C. TRYPAN BLUE
D. Negative Stain (copper)
Which is the correct fluid path in Liquid Chromatography system (Biologics LP) - ANSWERSA. Buffer
reservoir-sample loading-UV detector-Column-data collection
B. Column-data collection-UV detector-injector-Pump-buffer reservoir
C. Column-sample loop-injector-pump-UV detector-data collection
D. BUFFER RESERVOIR-INJECTOR-COLUMN-UV DETECTOR-DATA COLLECTION
Which of the following is not a consideration for a New Drug Application (NDA)? - ANSWERSA. an
assessment as to whether the product is reasonably safe for initial testing in humans ( i.e. toxicology
studies).
b. Are adequate GMP methods used to validate the drug's quality.
c. Benefits of drug product overweigh risks?
d. Is the drug's proposed labelling (package insert) appropriate, and what should it contain?
CMC information is totally specific to a product where as GMP ( or cGMP) typically tend to encompass
the manufacturer's overall operations. - ANSWERSA. True
, b. False
Which of the following would you most likely use in a Sterility test for final product? - ANSWERSa.
Ampoule dipped in 1%methylene blue dye solution
B. Membrane filter unit
c. Light absorption instrumentation
d. Analytical method such as HPLC
Bio manufacturing is the manipulation of non-living organisms or their components to produce
commercial products. - ANSWERSa. Ture
B. False
The key difference between a HEPA and a ULPA filter is? - ANSWERSA. ULPA filters can remove 99.99% of
the particulates that are 0.12 microns or more in diameter
b. The rate on how fast (velocity) that can trap a particle
c. HEPA filters remove 99.97 percent of particulates that are 0.3 microns or smaller in size.
d. ULPA filters remove 99.97 percent of particulates that are 0.3 microns or larger in size.
Which of the following statements is true (correct) about the fill-finish process? - ANSWERSa. Fill -finish
comes after upstream processing but before purification (i.e. chromatography).
B. The fill-finish step is of great economical value to the manufacturer
c. All of the statements are false.
d. Since this is the final step in the manufacturing process, the environment does not need to be tightly
regulated (controlled).
Which statement is correct (true) with regard to pyrogen testing? - ANSWERSA. The most common
pyrogens are endotoxins, which are lipopolysaccharides (LPS) produced by Gram-negative bacteria such
as E. coli.
b. The Monocyte Activation Test (MAT) uses the monocytes in rabbits to detect pyrogens.
c. LAL ( Limulus Amebocye Lysate)is a non-animal, human based test.
d. Horseshoe crabs are used to perform the test because their body temperature increases when
pyrogen is introduced by the parenteral route.
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