BIOTECHNOLOGY FINAL EXAM | 2026/2027
Biotechnology Comprehensive Final Examination with Complete Questions & Verified
Answers | Latest Version
Overview
This 2026/2027 updated resource contains the latest Biotechnology Comprehensive Final
Examination with the exact 120 questions and verified answers, following current BIO
(Biotechnology Innovation Organization) standards, FDA regulatory requirements, Good Manufacturing
Practices (GMP), and evidence-based biotechnological principles across all domains. Key Features
Actual biotechnology program final exam format with the official 120 questions
Comprehensive coverage of molecular biology, bioprocessing, and regulatory affairs
Updated 2026/2027 FDA guidance documents and international regulatory standards
Practical laboratory technique applications and bioprocess scale-up scenarios
Quality control and assurance protocols for biopharmaceutical manufacturing
Core Content Areas (120 Total Questions)
● Molecular Biology & Genetic Engineering (25 Qs)
● Cell Culture & Bioprocess Technology (22 Qs)
● Protein Purification & Characterization (20 Qs)
● Regulatory Affairs & Quality Systems (18 Qs)
● Biosafety & Environmental Controls (15 Qs)
● Analytical Methods & Instrumentation (12 Qs)
● Biotechnology Applications & Ethics (8 Qs)
Answer Format Correct answers are marked in bold green and include:
- FDA 21 CFR Part 210/211 and ICH Q7 GMP requirement applications
- Molecular cloning strategy design and validation
- Bioreactor scale-up calculations and parameter optimizations
- Chromatography method development and validation protocols
- Quality by Design (QbD) principles in bioprocess development
- Biosafety level (BSL) containment requirements for various agents
,Updates for 2026/2027
➢ Reflects 2026-2027 FDA gene therapy and cell-based product guidance updates
➢ Updated ICH (International Council for Harmonisation) quality guidelines
➢ Enhanced continuous bioprocessing and single-use technologies
➢ New CRISPR and gene editing regulatory frameworks
➢ Revised biosimilar and interchangeable product development pathways
➢ Updated environmental monitoring and contamination control standards
➢ New AI/ML applications in bioprocess optimization
➢ Revised biopharmaceutical intellectual property and patent considerations
Biotechnology Comprehensive Final Exam – 120 Questions & Verified Answers with
Rationales
1. Which enzyme is essential for joining DNA fragments with compatible sticky ends during
recombinant DNA construction?
A. DNA polymerase
B. Reverse transcriptase
C. DNA ligase
D. Restriction endonuclease
Rationale: DNA ligase catalyzes the formation of phosphodiester bonds between adjacent nucleotides,
sealing nicks in the DNA backbone and joining insert and vector fragments in cloning. Restriction
enzymes cut DNA; polymerases synthesize it.
2. In mammalian cell culture, what is the primary purpose of using a CO₂ incubator?
A. To sterilize the culture environment
B. To provide carbon for metabolism
C. To maintain physiological pH via bicarbonate buffer system
D. To increase oxygen solubility
Rationale: Most mammalian cell culture media use a sodium bicarbonate/CO₂ buffer system. A 5% CO₂
atmosphere maintains the correct pH (typically 7.2–7.4) by equilibrating with dissolved bicarbonate.
3. Which chromatography technique separates proteins based on surface charge?
,A. Size exclusion chromatography
B. Ion exchange chromatography
C. Affinity chromatography
D. Hydrophobic interaction chromatography
Rationale: Ion exchange chromatography uses charged resin (anionic or cationic) to bind proteins
based on opposite net surface charge. Elution is achieved by increasing ionic strength or changing pH.
4. According to FDA 21 CFR Part 211, who is responsible for approving batch production
records before release?
A. Quality Control
B. Quality Assurance
C. Manufacturing
D. Regulatory Affairs
Rationale: 21 CFR 211.188 and 211.192 require that Quality Control tests be performed and that Quality
Assurance (or the quality unit) review and approve all batch records for compliance before product
release.
5. What biosafety level (BSL) is required for work with Mycobacterium tuberculosis?
A. BSL-1
B. BSL-2
C. BSL-3
D. BSL-4
Rationale: M. tuberculosis is an aerosol-transmissible pathogen that causes serious respiratory disease.
CDC/NIH guidelines require BSL-3 containment, including directional airflow, HEPA filtration, and
respiratory protection.
6. Which analytical method is most appropriate for determining the primary structure of a
purified protein?
A. Circular dichroism
, B. Dynamic light scattering
C. Mass spectrometry with tandem MS/MS
D. Isothermal titration calorimetry
Rationale: Tandem mass spectrometry (MS/MS) fragments peptides and sequences them by
mass-to-charge ratio, enabling accurate determination of amino acid sequence (primary structure). CD
assesses secondary structure.
7. What is the primary ethical concern associated with germline gene editing in humans?
A. High cost of therapy
B. Informed consent challenges
C. Heritable genetic changes affecting future generations
D. Off-target effects only
Rationale: Germline edits are incorporated into sperm, eggs, or embryos and are passed to offspring,
raising concerns about unintended long-term consequences, eugenics, and lack of consent from future
generations.
8. In bioreactor scale-up, which parameter is typically held constant to maintain similar
cell physiology?
A. Impeller speed (RPM)
B. Tank diameter
C. Power per unit volume (P/V) or kLa
D. Total aeration rate (L/min)
Rationale: During scale-up, maintaining constant power input per volume (P/V) or oxygen transfer
coefficient (kLa) helps preserve mixing, oxygen supply, and shear stress—critical for consistent cell
growth and product quality.
9. Which FDA regulation specifically governs the manufacture of sterile drug products?
A. 21 CFR Part 210
B. 21 CFR Part 211, Subpart A and D
Biotechnology Comprehensive Final Examination with Complete Questions & Verified
Answers | Latest Version
Overview
This 2026/2027 updated resource contains the latest Biotechnology Comprehensive Final
Examination with the exact 120 questions and verified answers, following current BIO
(Biotechnology Innovation Organization) standards, FDA regulatory requirements, Good Manufacturing
Practices (GMP), and evidence-based biotechnological principles across all domains. Key Features
Actual biotechnology program final exam format with the official 120 questions
Comprehensive coverage of molecular biology, bioprocessing, and regulatory affairs
Updated 2026/2027 FDA guidance documents and international regulatory standards
Practical laboratory technique applications and bioprocess scale-up scenarios
Quality control and assurance protocols for biopharmaceutical manufacturing
Core Content Areas (120 Total Questions)
● Molecular Biology & Genetic Engineering (25 Qs)
● Cell Culture & Bioprocess Technology (22 Qs)
● Protein Purification & Characterization (20 Qs)
● Regulatory Affairs & Quality Systems (18 Qs)
● Biosafety & Environmental Controls (15 Qs)
● Analytical Methods & Instrumentation (12 Qs)
● Biotechnology Applications & Ethics (8 Qs)
Answer Format Correct answers are marked in bold green and include:
- FDA 21 CFR Part 210/211 and ICH Q7 GMP requirement applications
- Molecular cloning strategy design and validation
- Bioreactor scale-up calculations and parameter optimizations
- Chromatography method development and validation protocols
- Quality by Design (QbD) principles in bioprocess development
- Biosafety level (BSL) containment requirements for various agents
,Updates for 2026/2027
➢ Reflects 2026-2027 FDA gene therapy and cell-based product guidance updates
➢ Updated ICH (International Council for Harmonisation) quality guidelines
➢ Enhanced continuous bioprocessing and single-use technologies
➢ New CRISPR and gene editing regulatory frameworks
➢ Revised biosimilar and interchangeable product development pathways
➢ Updated environmental monitoring and contamination control standards
➢ New AI/ML applications in bioprocess optimization
➢ Revised biopharmaceutical intellectual property and patent considerations
Biotechnology Comprehensive Final Exam – 120 Questions & Verified Answers with
Rationales
1. Which enzyme is essential for joining DNA fragments with compatible sticky ends during
recombinant DNA construction?
A. DNA polymerase
B. Reverse transcriptase
C. DNA ligase
D. Restriction endonuclease
Rationale: DNA ligase catalyzes the formation of phosphodiester bonds between adjacent nucleotides,
sealing nicks in the DNA backbone and joining insert and vector fragments in cloning. Restriction
enzymes cut DNA; polymerases synthesize it.
2. In mammalian cell culture, what is the primary purpose of using a CO₂ incubator?
A. To sterilize the culture environment
B. To provide carbon for metabolism
C. To maintain physiological pH via bicarbonate buffer system
D. To increase oxygen solubility
Rationale: Most mammalian cell culture media use a sodium bicarbonate/CO₂ buffer system. A 5% CO₂
atmosphere maintains the correct pH (typically 7.2–7.4) by equilibrating with dissolved bicarbonate.
3. Which chromatography technique separates proteins based on surface charge?
,A. Size exclusion chromatography
B. Ion exchange chromatography
C. Affinity chromatography
D. Hydrophobic interaction chromatography
Rationale: Ion exchange chromatography uses charged resin (anionic or cationic) to bind proteins
based on opposite net surface charge. Elution is achieved by increasing ionic strength or changing pH.
4. According to FDA 21 CFR Part 211, who is responsible for approving batch production
records before release?
A. Quality Control
B. Quality Assurance
C. Manufacturing
D. Regulatory Affairs
Rationale: 21 CFR 211.188 and 211.192 require that Quality Control tests be performed and that Quality
Assurance (or the quality unit) review and approve all batch records for compliance before product
release.
5. What biosafety level (BSL) is required for work with Mycobacterium tuberculosis?
A. BSL-1
B. BSL-2
C. BSL-3
D. BSL-4
Rationale: M. tuberculosis is an aerosol-transmissible pathogen that causes serious respiratory disease.
CDC/NIH guidelines require BSL-3 containment, including directional airflow, HEPA filtration, and
respiratory protection.
6. Which analytical method is most appropriate for determining the primary structure of a
purified protein?
A. Circular dichroism
, B. Dynamic light scattering
C. Mass spectrometry with tandem MS/MS
D. Isothermal titration calorimetry
Rationale: Tandem mass spectrometry (MS/MS) fragments peptides and sequences them by
mass-to-charge ratio, enabling accurate determination of amino acid sequence (primary structure). CD
assesses secondary structure.
7. What is the primary ethical concern associated with germline gene editing in humans?
A. High cost of therapy
B. Informed consent challenges
C. Heritable genetic changes affecting future generations
D. Off-target effects only
Rationale: Germline edits are incorporated into sperm, eggs, or embryos and are passed to offspring,
raising concerns about unintended long-term consequences, eugenics, and lack of consent from future
generations.
8. In bioreactor scale-up, which parameter is typically held constant to maintain similar
cell physiology?
A. Impeller speed (RPM)
B. Tank diameter
C. Power per unit volume (P/V) or kLa
D. Total aeration rate (L/min)
Rationale: During scale-up, maintaining constant power input per volume (P/V) or oxygen transfer
coefficient (kLa) helps preserve mixing, oxygen supply, and shear stress—critical for consistent cell
growth and product quality.
9. Which FDA regulation specifically governs the manufacture of sterile drug products?
A. 21 CFR Part 210
B. 21 CFR Part 211, Subpart A and D
