Biotechnology harnesses cellular and biomolecular processes to develop technologies and products that help improve our lives and the health of our planet. For the pharmaceutical industry, it has been a revolutionary force, leading to the creation of advanced therapies. For PharmD students, understanding biotechnologies like recombinant DNA, CRISPR, and monoclonal antibody production is no longer optional; it is essential for comprehending the next generation of medicines you will dispense and manage.
1. What is the primary purpose of the Polymerase Chain Reaction (PCR) technique in biotechnology?
- To separate DNA fragments based on their size
- To determine the sequence of nucleotides in a DNA strand
- To amplify a specific segment of DNA exponentially
- To insert a gene into a plasmid vector
Answer: To amplify a specific segment of DNA exponentially
2. In recombinant DNA technology, which enzyme is responsible for “pasting” a gene of interest into a plasmid vector?
- DNA Polymerase
- Helicase
- DNA Ligase
- Restriction Endonuclease
Answer: DNA Ligase
3. Which of the following is a common mammalian cell line used for the large-scale production of recombinant proteins like monoclonal antibodies?
- Escherichia coli (E. coli)
- Saccharomyces cerevisiae (yeast)
- Chinese Hamster Ovary (CHO) cells
- Bacillus subtilis
Answer: Chinese Hamster Ovary (CHO) cells
4. The CRISPR-Cas9 system, a powerful gene-editing tool, was originally discovered in bacteria as a form of:
- Metabolic pathway
- Adaptive immune system against viruses
- Photosynthesis
- Cellular respiration
Answer: Adaptive immune system against viruses
5. Monoclonal antibodies are highly specific therapeutic agents. They are produced from:
- A diverse mixture of immune cells
- A single clone of a B-cell, ensuring all antibodies are identical
- Plant extracts
- Chemical synthesis from individual amino acids
Answer: A single clone of a B-cell, ensuring all antibodies are identical
6. Gel electrophoresis is a technique used to:
- Sequence a DNA molecule
- Separate macromolecules like DNA, RNA, and proteins based on size and charge
- Amplify a specific DNA sequence
- Insert DNA into a host cell
Answer: Separate macromolecules like DNA, RNA, and proteins based on size and charge
7. “Gene pharming” refers to the technology of:
- Using pharmaceuticals to alter genes in a patient
- Using transgenic animals or plants to produce therapeutic proteins
- Mining for genes in different organisms
- A database of pharmaceutical products
Answer: Using transgenic animals or plants to produce therapeutic proteins
8. What is the role of a vector in gene cloning?
- To cut the DNA at a specific site
- To carry the foreign DNA into a host cell
- To provide the energy for the reaction
- To separate the DNA fragments by size
Answer: To carry the foreign DNA into a host cell
9. Why is E. coli a commonly used host for producing simple recombinant proteins?
- It performs complex post-translational modifications
- It grows slowly and is expensive to culture
- It has a rapid growth rate and well-understood genetics
- It is a eukaryotic organism
Answer: It has a rapid growth rate and well-understood genetics
10. RNA interference (RNAi) is a mechanism that can be harnessed for therapeutic purposes to:
- Increase the production of a target protein
- Silence a specific gene by degrading its mRNA transcript
- Repair mutations in DNA
- Cause random mutations in the genome
Answer: Silence a specific gene by degrading its mRNA transcript
11. A key advantage of using mammalian cell cultures over bacterial systems for producing complex human proteins is that mammalian cells can:
- Grow much faster than bacteria
- Perform necessary post-translational modifications, like glycosylation
- Survive in much harsher temperature conditions
- Be cultured without the need for sterile technique
Answer: Perform necessary post-translational modifications, like glycosylation
12. In the context of gene therapy, what does “in vivo” gene therapy mean?
- Therapeutic genes are delivered directly into the patient’s body
- Cells are removed from the patient, modified in the lab, and then returned to the patient
- The therapy is tested in animals before humans
- The gene is delivered using a non-viral method
Answer: Therapeutic genes are delivered directly into the patient’s body
13. The purpose of a “selectable marker” (e.g., an antibiotic resistance gene) on a plasmid is to:
- Make the plasmid visible to the naked eye
- Allow researchers to identify which host cells have successfully taken up the plasmid
- Increase the rate of protein production
- Ensure the plasmid is cut at the correct location
Answer: Allow researchers to identify which host cells have successfully taken up the plasmid
14. What are antisense oligonucleotides designed to do?
- Bind to a specific mRNA sequence and block its translation into protein
- Cut DNA at a specific site
- Amplify DNA for analysis
- Serve as a template for protein synthesis
Answer: Bind to a specific mRNA sequence and block its translation into protein
15. A “transgenic plant” is one that:
- Has been grown in a different country
- Is resistant to all known pests
- Contains a gene or genes that have been artificially inserted
- Has been created through traditional cross-pollination only
Answer: Contains a gene or genes that have been artificially inserted
16. The Western blot technique is used to detect:
- Specific DNA sequences
- Specific RNA sequences
- Specific proteins in a sample
- The presence of lipids in a cell
Answer: Specific proteins in a sample
17. What is a primary challenge in developing effective viral vectors for gene therapy?
- Ensuring the vector can produce its own proteins
- Avoiding an immune response against the vector in the patient
- Making the virus more pathogenic
- Finding a virus that is large enough to be seen with a microscope
Answer: Avoiding an immune response against the vector in the patient
18. Induced pluripotent stem cells (iPSCs) are derived from:
- Embryos
- Umbilical cord blood
- Differentiated adult cells that have been reprogrammed to an embryonic-like state
- Fetal tissue
Answer: Differentiated adult cells that have been reprogrammed to an embryonic-like state
19. In a PCR cycle, what is the purpose of the heating step at ~95°C?
- To allow the primers to anneal to the DNA
- To denature the double-stranded DNA into single strands
- To allow the polymerase to extend the DNA
- To ligate the newly formed DNA fragments
Answer: To denature the double-stranded DNA into single strands
20. The term “biosimilar” refers to a biological product that is:
- A chemically synthesized small molecule drug
- Approved based on showing it is highly similar to an already-approved biological product
- Genetically identical to the reference product
- A generic version of a small molecule drug
Answer: Approved based on showing it is highly similar to an already-approved biological product
21. What is the function of the “guide RNA” in the CRISPR-Cas9 system?
- It cuts the target DNA
- It directs the Cas9 enzyme to a specific sequence in the genome
- It repairs the break in the DNA
- It acts as a template for protein synthesis
Answer: It directs the Cas9 enzyme to a specific sequence in the genome
22. Exosomes are small extracellular vesicles that have therapeutic potential because they can:
- Transport bioactive molecules like proteins and RNA between cells
- Integrate their own DNA into the host genome
- Replicate independently within the bloodstream
- Cause widespread inflammation
Answer: Transport bioactive molecules like proteins and RNA between cells
23. Hybridoma technology is a method used to produce:
- Recombinant proteins
- Transgenic animals
- Monoclonal antibodies
- DNA vaccines
Answer: Monoclonal antibodies
24. The development of mRNA vaccines relies on which core biological process?
- DNA replication
- Reverse transcription
- Protein translation by the host cell’s ribosomes
- Gene editing
Answer: Protein translation by the host cell’s ribosomes
25. A major advantage of using yeast (S. cerevisiae) over bacteria for protein expression is that yeast:
- Is a prokaryote
- Cannot be grown in large fermenters
- Is a eukaryote and can perform some post-translational modifications
- Does not have a cell wall
Answer: Is a eukaryote and can perform some post-translational modifications
26. Which step in PCR involves lowering the temperature to allow primers to bind to the template DNA?
- Denaturation
- Annealing
- Extension
- Ligation
Answer: Annealing
27. What is a potential ethical concern related to gene editing in humans?
- The high cost of the technology
- The potential for off-target effects and unintended mutations
- The rapid speed at which it can be performed
- The use of bacterial enzymes
Answer: The potential for off-target effects and unintended mutations
28. High-throughput screening (HTS) is a drug discovery process used to:
- Rapidly test thousands of chemical compounds for biological activity
- Manually synthesize a single, complex drug molecule
- Conduct late-stage clinical trials
- Formulate a finished drug product
Answer: Rapidly test thousands of chemical compounds for biological activity
29. The suffix “-mab” in a drug name (e.g., adalimumab) indicates that the drug is a:
- Small molecule inhibitor
- Monoclonal antibody
- Recombinant enzyme
- Synthetic peptide
Answer: Monoclonal antibody
30. What is a primary difference between a traditional vaccine and a DNA or mRNA vaccine?
- Traditional vaccines always provide lifelong immunity.
- DNA/mRNA vaccines use genetic material to prompt the body to make the antigen itself.
- Traditional vaccines do not stimulate an immune response.
- DNA/mRNA vaccines are made from live, attenuated viruses.
Answer: DNA/mRNA vaccines use genetic material to prompt the body to make the antigen itself.
31. In molecular cloning, a “blue-white screen” is used to:
- Measure the size of the DNA insert
- Differentiate host cells that contain a recombinant plasmid from those with a non-recombinant plasmid
- Amplify the DNA sequence
- Purify the final protein product
Answer: Differentiate host cells that contain a recombinant plasmid from those with a non-recombinant plasmid
32. The ability of stem cells to differentiate into many different cell types is known as:
- Pluripotency
- Homeostasis
- Apoptosis
- Necrosis
Answer: Pluripotency
33. What does the “Cas9” part of the CRISPR-Cas9 system refer to?
- A guide RNA molecule
- A protein that functions as a DNA-cutting enzyme (a nuclease)
- A type of plasmid vector
- A selectable marker
Answer: A protein that functions as a DNA-cutting enzyme (a nuclease)
34. A major challenge for RNA-based therapeutics like siRNA is:
- Their extreme stability in the bloodstream
- Their ability to easily cross cell membranes
- Their rapid degradation by nucleases and difficulty in delivery to target cells
- Their tendency to cause permanent genetic changes
Answer: Their rapid degradation by nucleases and difficulty in delivery to target cells
35. A Southern blot is a laboratory technique used to detect:
- A specific protein sequence
- A specific RNA sequence
- A specific DNA sequence
- A specific lipid
Answer: A specific DNA sequence
36. Zinc-finger nucleases (ZFNs) and TALENs are earlier forms of what type of biotechnology?
- DNA sequencing
- Protein purification
- Genome editing
- PCR amplification
Answer: Genome editing
37. The process of inserting a functional gene to correct the effect of a defective gene is the basis of:
- Gene therapy
- Pharmacogenomics
- Monoclonal antibody therapy
- Small molecule drug therapy
Answer: Gene therapy
38. What is the role of Taq polymerase in a PCR reaction?
- It is a heat-stable DNA polymerase that synthesizes new DNA strands
- It denatures the DNA template at high temperatures
- It acts as the primer for DNA synthesis
- It separates the PCR products via gel electrophoresis
Answer: It is a heat-stable DNA polymerase that synthesizes new DNA strands
39. A “knockout” mouse is a transgenic mouse in which:
- A specific gene has been inactivated or “knocked out”
- A foreign gene has been added
- The mouse’s immune system has been enhanced
- The mouse has been trained to perform a specific task
Answer: A specific gene has been inactivated or “knocked out”
40. The use of liposomes or nanoparticles in drug delivery is a technology primarily designed to:
- Increase a drug’s bitter taste
- Improve the stability, solubility, and targeted delivery of a therapeutic agent
- Ensure the drug is eliminated from the body as quickly as possible
- Make the drug visible on an X-ray
Answer: Improve the stability, solubility, and targeted delivery of a therapeutic agent
41. Which of the following is NOT a component needed for a PCR reaction?
- DNA template
- DNA polymerase
- Primers
- DNA ligase
Answer: DNA ligase
42. The term “bioreactor” refers to:
- A device or system used to grow cells or microorganisms for the production of biologicals
- A computer program that models biological reactions
- A natural products screening library
- A gene editing tool
Answer: A device or system used to grow cells or microorganisms for the production of biologicals
43. One advantage of viral vectors for gene therapy over non-viral methods is that they are generally:
- Less likely to cause an immune response
- Cheaper to produce
- More efficient at entering cells and delivering genes
- Easier to handle and store
Answer: More efficient at entering cells and delivering genes
44. In the production of a biopharmaceutical, “downstream processing” refers to:
- The initial cloning of the gene of interest
- The growth of the host cells in a fermenter
- The extraction, purification, and formulation of the final product
- The design of the clinical trial protocol
Answer: The extraction, purification, and formulation of the final product
45. Pharmacogenomics is a field that uses biotechnology to:
- Create new infectious diseases
- Understand how an individual’s genetic makeup affects their response to drugs
- Develop new flavors for liquid medications
- Study the history of pharmacy
Answer: Understand how an individual’s genetic makeup affects their response to drugs
46. The first human therapeutic protein produced using recombinant DNA technology was:
- Erythropoietin
- Insulin
- Growth hormone
- Factor VIII
Answer: Insulin
47. A “cDNA library” is a collection of DNA fragments that have been generated from:
- The entire genome of an organism
- mRNA molecules using reverse transcriptase
- The protein content of a cell
- Plasmids from a bacterial culture
Answer: mRNA molecules using reverse transcriptase
48. What is a key safety consideration during the development of cell-based therapies?
- Ensuring the cells are of the correct color
- The risk of the cells becoming contaminated or forming tumors after administration
- The ability of the cells to survive without oxygen
- The cost of the growth medium
Answer: The risk of the cells becoming contaminated or forming tumors after administration
49. An ELISA (Enzyme-Linked Immunosorbent Assay) is a common biotechnological tool used for:
- Amplifying DNA
- Cutting DNA
- Detecting and quantifying a substance, such as a protein or antibody
- Sequencing a genome
Answer: Detecting and quantifying a substance, such as a protein or antibody
50. The ultimate goal of applying biotechnologies in pharmacy is to:
- Replace all small molecule drugs
- Create more personalized and effective medicines
- Make the process of drug development more complicated
- Focus only on treating rare genetic diseases
Answer: Create more personalized and effective medicines
