Q.1 What is the primary purpose of recombinant DNA technology in pharmaceutical biotechnology?
To increase the conductivity of electrical circuits
To clone whole organisms
To produce therapeutic proteins in host cells
To develop new battery materials
Explanation - Recombinant DNA allows insertion of a gene encoding a therapeutic protein into a host cell (e.g., bacteria, yeast) so that the cell can produce the protein in large quantities.
Correct answer is: To produce therapeutic proteins in host cells
Q.2 Which of the following is a common host organism used for the production of insulin?
Escherichia coli
Saccharomyces cerevisiae
Bacillus subtilis
Pseudomonas aeruginosa
Explanation - Human insulin was first produced commercially using genetically engineered E. coli, which can express the insulin gene efficiently.
Correct answer is: Escherichia coli
Q.3 In the context of biopharmaceuticals, what does the term "biosimilar" mean?
A drug that is chemically identical to a small‑molecule drug
A biologic that is highly similar to an already approved reference product
A synthetic version of a natural hormone
A vaccine that uses live attenuated viruses
Explanation - Biosimilars are not identical copies (as generics are for small molecules) but must demonstrate no clinically meaningful differences in safety, purity, and potency compared with the reference biologic.
Correct answer is: A biologic that is highly similar to an already approved reference product
Q.4 Which analytical technique is most widely used to verify the primary amino‑acid sequence of a recombinant protein?
Mass spectrometry (MS)
Nuclear magnetic resonance (NMR)
X‑ray crystallography
Gel electrophoresis
Explanation - MS can accurately determine the mass of peptide fragments, allowing reconstruction of the full amino‑acid sequence of a protein.
Correct answer is: Mass spectrometry (MS)
Q.5 What is the role of a promoter in a gene expression vector?
To terminate transcription
To initiate transcription of the downstream gene
To replicate the plasmid inside the host
To encode the therapeutic protein
Explanation - Promoters contain binding sites for RNA polymerase and transcription factors, driving transcription of the gene placed downstream of them.
Correct answer is: To initiate transcription of the downstream gene
Q.6 Which purification method separates proteins based on their charge?
Size‑exclusion chromatography
Ion‑exchange chromatography
Affinity chromatography
Hydrophobic interaction chromatography
Explanation - Ion‑exchange chromatography uses charged resins that bind proteins of opposite charge, allowing separation based on net surface charge at a given pH.
Correct answer is: Ion‑exchange chromatography
Q.7 What does the term "post‑translational modification" refer to?
Changes to DNA after replication
Alterations to a protein after it is synthesized
Modification of RNA during transcription
Changes in the cell membrane composition
Explanation - Post‑translational modifications (PTMs) such as glycosylation, phosphorylation, or cleavage occur after the polypeptide chain is made, affecting protein function and stability.
Correct answer is: Alterations to a protein after it is synthesized
Q.8 Which type of vaccine uses a piece of DNA to encode an antigen inside the host’s cells?
Live‑attenuated vaccine
Inactivated vaccine
DNA vaccine
Subunit vaccine
Explanation - DNA vaccines deliver plasmid DNA that encodes an antigen; host cells translate the DNA, producing the antigen internally and stimulating immunity.
Correct answer is: DNA vaccine
Q.9 What is the main advantage of using yeast (e.g., Saccharomyces cerevisiae) as a host for producing recombinant proteins?
Yeast cells are prokaryotic and grow faster than bacteria
Yeast can perform eukaryotic post‑translational modifications
Yeast does not require any nutrient supplementation
Yeast produces proteins with no glycosylation
Explanation - Yeast, being eukaryotic, can carry out many PTMs such as glycosylation, which are essential for the activity and stability of many therapeutic proteins.
Correct answer is: Yeast can perform eukaryotic post‑translational modifications
Q.10 Which of the following is NOT a typical step in downstream processing of a biopharmaceutical?
Cell lysis
Chromatographic purification
Fermentation optimization
Formulation and fill‑finish
Explanation - Fermentation optimization is an upstream process. Downstream processing includes cell harvest, lysis, purification, and final formulation.
Correct answer is: Fermentation optimization
Q.11 In bioreactor operation, what does the term "batch culture" mean?
Continuous addition of fresh medium and removal of product
A closed system where no material is added or removed after inoculation
A system where only gases are exchanged
A method that uses solid media instead of liquid
Explanation - In batch culture, the reactor is inoculated and then sealed; cells grow until nutrients are exhausted or product is harvested.
Correct answer is: A closed system where no material is added or removed after inoculation
Q.12 Which regulatory body is primarily responsible for approving biopharmaceuticals in the United States?
European Medicines Agency (EMA)
Food and Drug Administration (FDA)
World Health Organization (WHO)
National Institutes of Health (NIH)
Explanation - The FDA's Center for Drug Evaluation and Research (CDER) evaluates and approves new drugs, including biologics, before they can be marketed in the US.
Correct answer is: Food and Drug Administration (FDA)
Q.13 What does the abbreviation "GMP" stand for in biopharmaceutical manufacturing?
General Manufacturing Procedure
Good Manufacturing Practice
Genetic Modification Protocol
Global Market Position
Explanation - GMP guidelines ensure that products are consistently produced and controlled according to quality standards.
Correct answer is: Good Manufacturing Practice
Q.14 Which of the following best describes a monoclonal antibody?
A mixture of antibodies produced by different B‑cells
A single type of antibody derived from one B‑cell clone
An antibody fragment lacking the Fc region
A synthetic peptide that mimics an antigen
Explanation - Monoclonal antibodies are identical antibodies produced by a single clone of B‑cells, providing specificity for a single epitope.
Correct answer is: A single type of antibody derived from one B‑cell clone
Q.15 What is the main function of an affinity tag (e.g., His‑tag) attached to a recombinant protein?
To increase the protein’s enzymatic activity
To facilitate purification by binding to a specific resin
To improve the protein’s stability in vivo
To serve as a vaccine adjuvant
Explanation - Affinity tags bind to complementary ligands on chromatography media (e.g., nickel for His‑tag), allowing selective capture of the tagged protein.
Correct answer is: To facilitate purification by binding to a specific resin
Q.16 Which of the following is a major challenge when producing therapeutic proteins in mammalian cell lines?
Inability to perform any post‑translational modifications
Low growth rates and high production costs
Lack of plasmid replication mechanisms
Absence of a secretory pathway
Explanation - Mammalian cells grow slower than microbes and require expensive media, making production costly despite their ability to perform complex PTMs.
Correct answer is: Low growth rates and high production costs
Q.17 Which type of bioreactor is commonly used for the production of virus‑based vaccines?
Stirred‑tank bioreactor
Air‑lift bioreactor
Fixed‑bed reactor
Membrane bioreactor
Explanation - Stirred‑tank bioreactors provide good mixing, oxygen transfer, and temperature control, making them suitable for high‑density viral production.
Correct answer is: Stirred‑tank bioreactor
Q.18 In the context of drug delivery, what does the term "bioavailability" refer to?
The rate at which a drug degrades in storage
The fraction of an administered dose that reaches systemic circulation unchanged
The total number of doses a patient receives per day
The ability of a drug to cross the blood‑brain barrier
Explanation - Bioavailability quantifies how much of the active drug reaches the bloodstream in an unchanged form after administration.
Correct answer is: The fraction of an administered dose that reaches systemic circulation unchanged
Q.19 Which of the following is an example of a gene therapy product approved for clinical use?
Aspirin
Humira (adalimumab)
Luxturna (voretigene neparvovec)
Metformin
Explanation - Luxturna delivers a functional copy of the RPE65 gene to treat inherited retinal dystrophy, representing an approved gene therapy.
Correct answer is: Luxturna (voretigene neparvovec)
Q.20 Which of the following best describes the purpose of a "vector" in recombinant DNA technology?
A molecule that degrades mRNA
A carrier DNA that transports the gene of interest into a host cell
A protein that enhances enzyme activity
A lipid that forms cell membranes
Explanation - Vectors (e.g., plasmids, viruses) are engineered DNA molecules used to deliver foreign genes into target cells for expression.
Correct answer is: A carrier DNA that transports the gene of interest into a host cell
Q.21 What is the primary difference between a "live‑attenuated" vaccine and an "inactivated" vaccine?
Live‑attenuated vaccines contain dead pathogens, while inactivated vaccines contain live pathogens.
Live‑attenuated vaccines use weakened pathogens that can replicate; inactivated vaccines contain killed pathogens that cannot replicate.
Live‑attenuated vaccines are made from purified proteins, whereas inactivated vaccines are made from DNA.
Live‑attenuated vaccines are always administered orally, while inactivated vaccines are injected.
Explanation - Attenuation reduces virulence but retains the ability to replicate, eliciting strong immunity; inactivated vaccines rely on immune response to dead organisms.
Correct answer is: Live‑attenuated vaccines use weakened pathogens that can replicate; inactivated vaccines contain killed pathogens that cannot replicate.
Q.22 Which of the following processes is used to break open bacterial cells to release intracellular recombinant proteins?
Centrifugation
Ultrafiltration
Sonication
Lyophilization
Explanation - Sonication uses high‑frequency sound waves to disrupt cell membranes, releasing intracellular contents.
Correct answer is: Sonication
Q.23 In biopharmaceutical manufacturing, what does the term "scale‑up" refer to?
Increasing the genetic size of the plasmid
Moving production from laboratory to commercial scale while maintaining product quality
Reducing the size of the drug molecule
Decreasing the temperature of the bioreactor
Explanation - Scale‑up involves translating a process optimized at a small scale to larger volumes without losing performance or product attributes.
Correct answer is: Moving production from laboratory to commercial scale while maintaining product quality
Q.24 Which analytical technique is commonly employed to assess the glycosylation pattern of a therapeutic antibody?
High‑performance liquid chromatography (HPLC) with fluorescence detection
Gas chromatography‑mass spectrometry (GC‑MS)
Capillary electrophoresis (CE)
Nuclear magnetic resonance (NMR) spectroscopy
Explanation - HPLC, especially after labeling glycans with fluorescent tags, allows detailed profiling of glycan structures attached to antibodies.
Correct answer is: High‑performance liquid chromatography (HPLC) with fluorescence detection
Q.25 What is the main reason for adding a signal peptide to a recombinant protein expressed in a mammalian cell line?
To increase the protein’s catalytic activity
To direct the protein to the secretory pathway for extracellular secretion
To enhance the DNA replication rate
To prevent proteolytic degradation inside the nucleus
Explanation - Signal peptides are recognized by the endoplasmic reticulum, guiding nascent proteins into the secretory pathway where they can be secreted into the culture medium.
Correct answer is: To direct the protein to the secretory pathway for extracellular secretion
Q.26 Which type of chromatography separates proteins based on hydrophobic interactions?
Ion‑exchange chromatography
Hydrophobic interaction chromatography (HIC)
Size‑exclusion chromatography
Affinity chromatography
Explanation - HIC uses a high‑salt buffer to promote binding of hydrophobic regions on proteins to a hydrophobic resin, eluting them by decreasing salt concentration.
Correct answer is: Hydrophobic interaction chromatography (HIC)
Q.27 In the context of vaccine development, what does the term "adjuvant" refer to?
A component that directly kills pathogens
A substance that enhances the immune response to the antigen
A preservative that increases shelf life
A stabilizer that prevents protein aggregation
Explanation - Adjuvants stimulate the immune system, allowing lower antigen doses and stronger, longer‑lasting immunity.
Correct answer is: A substance that enhances the immune response to the antigen
Q.28 Which of the following statements about CRISPR‑Cas9 in pharmaceutical biotechnology is true?
It can only edit bacterial genomes
It enables precise, programmable editing of DNA in a wide range of cells
It replaces the need for any downstream purification steps
It is used to amplify RNA molecules
Explanation - CRISPR‑Cas9 uses a guide RNA to target specific DNA sequences, allowing targeted modifications in many organisms, including human cells for therapeutic purposes.
Correct answer is: It enables precise, programmable editing of DNA in a wide range of cells
Q.29 What is the main advantage of using a "single‑use" bioreactor over a traditional stainless‑steel bioreactor?
Higher temperature tolerance
Elimination of cleaning and sterilization between batches
Ability to operate at higher pressures
Reduced oxygen transfer limitations
Explanation - Single‑use reactors use disposable liners, reducing cross‑contamination risk and turnaround time, albeit with higher material costs.
Correct answer is: Elimination of cleaning and sterilization between batches
Q.30 Which of the following is a typical characteristic of a "small‑molecule" drug compared to a biologic?
Molecular weight > 10,000 Da
Produced by recombinant DNA technology
Synthesized via chemical reactions and usually < 900 Da
Requires a cold‑chain for storage
Explanation - Small‑molecule drugs are chemically synthesized, low molecular weight compounds, whereas biologics are larger, often protein‑based products.
Correct answer is: Synthesized via chemical reactions and usually < 900 Da
Q.31 During the production of recombinant monoclonal antibodies, which region of the antibody is typically engineered to reduce immunogenicity?
Variable heavy (VH) region
Constant Fc region
Complementarity‑determining regions (CDRs)
Signal peptide
Explanation - Humanization often involves grafting mouse CDRs onto a human Fc scaffold to minimize immune reactions while retaining antigen specificity.
Correct answer is: Constant Fc region
Q.32 Which of the following best describes the term "pharmacokinetics"?
The study of drug effects on the body
The study of how the body absorbs, distributes, metabolizes, and excretes a drug
The analysis of drug chemical structure
The design of drug delivery devices
Explanation - Pharmacokinetics (PK) covers ADME processes that determine drug concentration over time.
Correct answer is: The study of how the body absorbs, distributes, metabolizes, and excretes a drug
Q.33 In the context of bioprocess monitoring, what does a "pH probe" measure?
Electrical conductivity of the medium
Concentration of dissolved oxygen
Acidity or basicity of the culture broth
Temperature of the reactor
Explanation - A pH probe detects hydrogen ion activity, providing real‑time data on the acidity or alkalinity of the culture environment.
Correct answer is: Acidity or basicity of the culture broth
Q.34 Which of the following is a major safety concern when using viral vectors for gene therapy?
Low transduction efficiency
Insertional mutagenesis leading to oncogenesis
Inability to enter mammalian cells
Excessive protein folding in the host
Explanation - Integration of viral DNA near oncogenes can disrupt normal gene regulation, potentially causing cancer.
Correct answer is: Insertional mutagenesis leading to oncogenesis
Q.35 What is the main purpose of a "formulation" step in biopharmaceutical development?
To clone the gene of interest
To adjust the drug into a stable, deliverable form (e.g., lyophilized powder, solution)
To sequence the DNA of the product
To design the manufacturing facility
Explanation - Formulation adds excipients, stabilizers, and determines the dosage form to ensure product stability, efficacy, and patient compliance.
Correct answer is: To adjust the drug into a stable, deliverable form (e.g., lyophilized powder, solution)
Q.36 Which of the following best explains why thermostable enzymes are valuable in industrial biotechnology?
They function only at low temperatures, reducing energy costs.
They retain activity at high temperatures, allowing faster reactions and reduced contamination.
They are less specific, enabling multiple reactions simultaneously.
They can be stored indefinitely without any preservation methods.
Explanation - Thermostable enzymes operate efficiently at elevated temperatures, increasing reaction rates and minimizing microbial contamination.
Correct answer is: They retain activity at high temperatures, allowing faster reactions and reduced contamination.
Q.37 In the context of viral vaccine production, what does the term "seed stock" refer to?
The initial virus isolate used to start the manufacturing process
A collection of frozen human plasma
A database of DNA sequences
A type of cell culture media
Explanation - Seed stock is a well‑characterized, low‑passage virus preparation that serves as the starting material for vaccine production.
Correct answer is: The initial virus isolate used to start the manufacturing process
Q.38 Which of the following is a characteristic advantage of using cell‑free protein synthesis systems?
They allow post‑translational modifications identical to those in mammalian cells.
They eliminate the need for living cells, reducing contamination risk and enabling rapid protein production.
They are cheaper than traditional microbial fermentation.
They can produce DNA plasmids directly.
Explanation - Cell‑free systems use extracts containing translation machinery, enabling quick synthesis of proteins without cell growth constraints.
Correct answer is: They eliminate the need for living cells, reducing contamination risk and enabling rapid protein production.
Q.39 What is the purpose of a "sterile filter" (0.22 µm) in biopharmaceutical processing?
To remove proteins larger than 100 kDa
To eliminate bacterial contamination while allowing passage of most proteins and viruses
To sterilize the product by heat
To concentrate the drug solution
Explanation - A 0.22 µm membrane filter retains bacteria but lets dissolved proteins and many viruses pass, providing aseptic filtration.
Correct answer is: To eliminate bacterial contamination while allowing passage of most proteins and viruses
Q.40 Which of the following best describes the function of a "glycosylation site" on a therapeutic protein?
A region that binds metal ions
A sequence where carbohydrate chains are enzymatically attached, affecting stability and activity
A motif that determines the protein’s isoelectric point
A cleavage site for proteases
Explanation - Glycosylation sites (typically Asn-X-Ser/Thr) are where N‑linked glycans are added, influencing solubility, half‑life, and immunogenicity.
Correct answer is: A sequence where carbohydrate chains are enzymatically attached, affecting stability and activity
Q.41 In bioprocess engineering, what does the term "oxygen transfer rate (OTR)" refer to?
The speed at which oxygen is removed from the medium
The rate at which dissolved oxygen is supplied to the culture by agitation and sparging
The concentration of oxygen in the gas phase
The amount of oxygen bound to hemoglobin in the product
Explanation - OTR measures how efficiently oxygen moves from the gas phase into the liquid culture, critical for aerobic microbial growth.
Correct answer is: The rate at which dissolved oxygen is supplied to the culture by agitation and sparging
Q.42 Which of the following is a key regulatory requirement for the labeling of a biopharmaceutical product?
Listing the DNA sequence of the expression vector
Providing the drug’s generic name, dosage form, strength, and storage conditions
Including the name of the research lab that discovered the protein
Specifying the voltage used in the manufacturing facility
Explanation - Regulatory labeling must convey essential information for safe use, including name, dosage, route, and storage.
Correct answer is: Providing the drug’s generic name, dosage form, strength, and storage conditions
Q.43 Which of the following best defines a "pharmacophore"?
The part of a drug molecule responsible for its taste
A 3‑D arrangement of features necessary for biological activity
The chemical formula of a drug
The process of drug metabolism in the liver
Explanation - A pharmacophore represents the spatial arrangement of functional groups (e.g., H‑bond donors/acceptors) essential for interacting with a target.
Correct answer is: A 3‑D arrangement of features necessary for biological activity
Q.44 What is the main purpose of a "cell bank" in biopharmaceutical production?
To store large quantities of the final drug product
To keep a repository of well‑characterized, cryopreserved cell lines for consistent manufacturing
To house bacterial cultures used for cleaning the facility
To hold a collection of plasmid DNA for research
Explanation - Cell banks (master and working) provide a stable source of cells with defined properties, ensuring reproducibility across batches.
Correct answer is: To keep a repository of well‑characterized, cryopreserved cell lines for consistent manufacturing
Q.45 Which method is commonly used to determine the molecular weight distribution of a protein mixture?
Western blotting
Size‑exclusion chromatography (SEC)
Polymerase chain reaction (PCR)
Northern blotting
Explanation - SEC separates molecules based on size, allowing estimation of molecular weight distribution of proteins.
Correct answer is: Size‑exclusion chromatography (SEC)
Q.46 In the context of mRNA vaccines, what is the role of the "5' cap" added to the mRNA strand?
It protects mRNA from degradation and facilitates ribosome binding for translation
It acts as a fluorescent marker for imaging
It encodes the antigenic peptide
It triggers an immediate immune response
Explanation - The 5' cap structure stabilizes mRNA and is recognized by the translation initiation machinery, enhancing protein production.
Correct answer is: It protects mRNA from degradation and facilitates ribosome binding for translation
Q.47 Which of the following statements about "bioburden testing" is correct?
It measures the concentration of the active pharmaceutical ingredient.
It quantifies the total number of viable microorganisms in a product or component.
It determines the amount of residual solvents.
It evaluates the electrical conductivity of a solution.
Explanation - Bioburden testing assesses microbial contamination levels before sterilization steps.
Correct answer is: It quantifies the total number of viable microorganisms in a product or component.
Q.48 Which of the following is a common method for viral inactivation during purification of a recombinant protein expressed in mammalian cells?
Low‑pH treatment
Heat sterilization at 121 °C
UV irradiation
Addition of antibiotics
Explanation - Transient exposure to low pH (e.g., pH 3.5) can inactivate many enveloped viruses without denaturing most proteins.
Correct answer is: Low‑pH treatment
Q.49 What does the term "half‑life" of a drug refer to?
The time required for half of the drug to be administered
The period during which the drug is most effective
The time required for the plasma concentration of the drug to reduce by 50 %
The duration of the clinical trial
Explanation - Half‑life is a pharmacokinetic parameter indicating how quickly a drug is eliminated from the body.
Correct answer is: The time required for the plasma concentration of the drug to reduce by 50 %
Q.50 Which of the following best explains why lyophilization (freeze‑drying) is used for many biologic drugs?
It increases the drug’s potency
It removes water, enhancing stability and extending shelf‑life
It changes the drug’s primary structure
It adds a sweet taste to the formulation
Explanation - Lyophilization preserves proteins by removing moisture, reducing degradation pathways like hydrolysis.
Correct answer is: It removes water, enhancing stability and extending shelf‑life
Q.51 In the context of bioprocess control, what is a "PID controller" used for?
To predict patient responses to a drug
To regulate process variables (e.g., temperature, pH) by calculating proportional, integral, and derivative actions
To design genetic circuits in cells
To analyze protein sequences
Explanation - PID controllers continuously adjust control inputs to maintain a setpoint by considering present error, accumulated error, and rate of change.
Correct answer is: To regulate process variables (e.g., temperature, pH) by calculating proportional, integral, and derivative actions
Q.52 Which of the following is a primary reason to use a "CHO" cell line for producing therapeutic antibodies?
CHO cells grow faster than bacteria
CHO cells are capable of human‑like glycosylation patterns
CHO cells do not require any media supplements
CHO cells produce viral particles naturally
Explanation - Chinese hamster ovary (CHO) cells produce complex glycans similar to those in humans, essential for antibody efficacy and safety.
Correct answer is: CHO cells are capable of human‑like glycosylation patterns
Q.53 What is the primary purpose of a "titer" measurement in vaccine production?
To assess the concentration of antigen or virus particles in a preparation
To determine the pH of the vaccine
To measure the electrical conductivity of the solution
To calculate the dosage of adjuvant required
Explanation - Titer quantifies the amount of active component (e.g., virus particles) to ensure consistent potency across batches.
Correct answer is: To assess the concentration of antigen or virus particles in a preparation
Q.54 Which type of mutation is most commonly introduced during error‑prone PCR to generate antibody diversity?
Large chromosomal deletions
Point mutations (single‑base changes)
Insertion of whole genes
Translocations
Explanation - Error‑prone PCR deliberately reduces fidelity of DNA polymerase, leading to random point mutations that diversify antibody sequences.
Correct answer is: Point mutations (single‑base changes)
Q.55 What is the main advantage of using a "continuous bioprocess" over a traditional batch process?
It eliminates the need for any purification steps.
It enables steady‑state operation, higher productivity, and smaller facility footprints.
It requires no monitoring of process parameters.
It produces only small‑molecule drugs.
Explanation - Continuous processes run non‑stop, offering consistent product quality, reduced downtime, and potentially lower costs.
Correct answer is: It enables steady‑state operation, higher productivity, and smaller facility footprints.
Q.56 In the context of antibody drug conjugates (ADCs), what does the "linker" component do?
It binds the drug payload to the antibody and can be designed to release the drug inside target cells.
It enhances the antibody’s affinity for its antigen.
It stabilizes the mRNA used to produce the antibody.
It acts as an adjuvant to boost the immune response.
Explanation - Linkers connect cytotoxic drugs to antibodies; they can be cleavable (e.g., by lysosomal enzymes) to release the payload upon internalization.
Correct answer is: It binds the drug payload to the antibody and can be designed to release the drug inside target cells.
Q.57 Which analytical technique is most suitable for detecting low‑level endotoxin contamination in a biologic product?
Limulus Amebocyte Lysate (LAL) assay
ELISA for protein quantification
PCR for DNA detection
Mass spectrometry for peptide mapping
Explanation - The LAL test uses enzymes from horseshoe crab blood to detect endotoxin (lipopolysaccharide) with high sensitivity.
Correct answer is: Limulus Amebocyte Lysate (LAL) assay
Q.58 What is the purpose of "codon optimization" when designing a gene for expression in a heterologous host?
To change the protein’s amino‑acid sequence
To replace rare codons with those preferred by the host, improving translation efficiency
To increase the GC content of the plasmid
To add restriction sites for cloning
Explanation - Codon optimization aligns the gene’s codon usage with the host’s tRNA abundance, enhancing protein expression levels.
Correct answer is: To replace rare codons with those preferred by the host, improving translation efficiency
Q.59 Which of the following best describes the role of "RNA interference (RNAi)" in therapeutic applications?
It amplifies DNA replication in target cells.
It degrades specific mRNA molecules, reducing expression of disease‑related proteins.
It directly modifies the genome sequence.
It increases the half‑life of therapeutic proteins.
Explanation - RNAi utilizes small interfering RNAs (siRNAs) to guide the RISC complex to complementary mRNA, leading to its cleavage and silencing.
Correct answer is: It degrades specific mRNA molecules, reducing expression of disease‑related proteins.
Q.60 In vaccine stability studies, what does the term "cold chain" refer to?
A series of temperature‑controlled steps from manufacturing to administration
A method of viral inactivation using cold temperatures
A genetic engineering technique
A type of chromatography used for protein purification
Explanation - Maintaining the cold chain (2‑8 °C or lower) preserves vaccine potency throughout distribution.
Correct answer is: A series of temperature‑controlled steps from manufacturing to administration
Q.61 Which of the following is NOT a typical attribute measured during the characterization of a biopharmaceutical?
Purity and impurity profile
Biological activity
Electrical resistance of the production facility
Stability under various storage conditions
Explanation - Facility electrical resistance is not a product quality attribute; purity, activity, and stability are critical QC parameters.
Correct answer is: Electrical resistance of the production facility
Q.62 What is the main reason for using "glycoengineering" when producing therapeutic antibodies?
To increase the antibody’s molecular weight
To modify carbohydrate structures to improve efficacy and reduce immunogenicity
To change the antibody’s antigen‑binding site
To enable the antibody to cross the blood‑brain barrier
Explanation - Glycoengineering tailors Fc glycans, enhancing antibody‑dependent cellular cytotoxicity (ADCC) and serum half‑life.
Correct answer is: To modify carbohydrate structures to improve efficacy and reduce immunogenicity
Q.63 Which of the following best defines "pharmacodynamics"?
The study of drug absorption, distribution, metabolism, and excretion
The study of the biochemical and physiological effects of drugs and their mechanisms of action
The analysis of drug manufacturing processes
The design of drug delivery devices
Explanation - Pharmacodynamics (PD) describes how drugs interact with biological targets to produce therapeutic or adverse effects.
Correct answer is: The study of the biochemical and physiological effects of drugs and their mechanisms of action
Q.64 In the context of cell culture, what does the term "batch‑to‑batch variability" refer to?
Differences in product quality between successive production runs
Variations in the electrical power supply to the facility
Changes in the DNA sequence of the expression vector
Fluctuations in the market price of raw materials
Explanation - Batch‑to‑batch variability can arise from subtle differences in media, inoculum, or process conditions, impacting consistency.
Correct answer is: Differences in product quality between successive production runs
Q.65 Which of the following is a common method for measuring the concentration of a protein in a bioprocess sample?
Bradford assay
BCA assay
Both Bradford and BCA assays
All of the above
Explanation - Both Bradford and BCA assays are colorimetric methods used to quantify protein concentration in solution.
Correct answer is: All of the above
Q.66 What is the purpose of a "cell‑culture‑derived viral vector" in gene therapy?
To act as a nutrient source for the host cells
To deliver therapeutic genes into patient cells with high efficiency
To serve as a vaccine adjuvant
To increase the viscosity of the formulation
Explanation - Cell‑culture‑derived viral vectors (e.g., AAV, lentivirus) are engineered to carry therapeutic DNA into target cells.
Correct answer is: To deliver therapeutic genes into patient cells with high efficiency
Q.67 Which of the following statements about "bioprocess analytical technology (PAT)" is correct?
PAT replaces the need for any quality control testing.
PAT provides real‑time monitoring and control of critical process parameters to ensure consistent product quality.
PAT is only used during final product packaging.
PAT is a type of chromatography.
Explanation - PAT integrates sensors and data analysis to enable proactive control and assurance of manufacturing processes.
Correct answer is: PAT provides real‑time monitoring and control of critical process parameters to ensure consistent product quality.
Q.68 Which of the following best describes a "biologic"?
A small chemical compound synthesized by organic chemistry
A product derived from living organisms, such as proteins, nucleic acids, or cells
A metal alloy used in medical implants
An inorganic mineral supplement
Explanation - Biologics encompass therapeutics like monoclonal antibodies, vaccines, cell therapies, and recombinant proteins.
Correct answer is: A product derived from living organisms, such as proteins, nucleic acids, or cells
Q.69 In recombinant protein production, what is the main purpose of adding a "poly‑histidine tag" (His‑tag) to the protein sequence?
To increase protein solubility
To enable purification by nickel‑affinity chromatography
To improve the protein's catalytic activity
To act as an immunogenic epitope
Explanation - His‑tags bind to nickel ions on an affinity column, allowing selective capture of the tagged protein.
Correct answer is: To enable purification by nickel‑affinity chromatography
Q.70 Which of the following is a key consideration when designing a "controlled‑release" formulation for a biologic drug?
Ensuring the formulation remains stable at physiological temperature for the intended release period
Maximizing the drug's electrical conductivity
Using the smallest possible particle size regardless of stability
Eliminating all excipients
Explanation - Controlled‑release systems must protect the biologic from degradation while releasing the drug at a predictable rate.
Correct answer is: Ensuring the formulation remains stable at physiological temperature for the intended release period
Q.71 What is the primary advantage of using "site‑directed mutagenesis" in protein engineering?
It randomly introduces mutations throughout the gene
It enables precise alteration of specific amino‑acid residues to modify protein function
It reduces the overall size of the protein
It automatically enhances protein expression levels
Explanation - Site‑directed mutagenesis allows targeted changes at defined positions, facilitating structure‑function studies and optimization.
Correct answer is: It enables precise alteration of specific amino‑acid residues to modify protein function
Q.72 Which of the following is an example of a “carrier‑mediated” drug delivery system?
A tablet that dissolves instantly in the stomach
Liposomes encapsulating a chemotherapeutic agent
A patch that releases drug via diffusion
A solution administered intravenously
Explanation - Liposomes act as carriers that protect and deliver the drug to target tissues, often improving pharmacokinetics.
Correct answer is: Liposomes encapsulating a chemotherapeutic agent
Q.73 In the context of biopharmaceutical manufacturing, what does the abbreviation "DSP" stand for?
Digital Signal Processing
Downstream Processing
Dynamic Solvent Partitioning
Direct Synthesis Procedure
Explanation - DSP refers to the series of steps after the bioreaction—cell harvest, lysis, purification, and formulation.
Correct answer is: Downstream Processing
Q.74 Which of the following best defines "immunogenicity" in the context of therapeutic proteins?
The ability of a protein to bind to its target receptor
The tendency of a protein to provoke an unwanted immune response in the patient
The electrical charge of the protein surface
The solubility of the protein in aqueous solution
Explanation - Immunogenicity can lead to neutralizing antibodies that reduce efficacy or cause adverse reactions.
Correct answer is: The tendency of a protein to provoke an unwanted immune response in the patient
Q.75 Which analytical method is commonly employed to assess the secondary structure content (α‑helix, β‑sheet) of a purified protein?
Circular dichroism (CD) spectroscopy
Gas chromatography (GC)
Atomic absorption spectroscopy (AAS)
Fluorescence microscopy
Explanation - CD measures differential absorption of circularly polarized light, providing information on protein secondary structure.
Correct answer is: Circular dichroism (CD) spectroscopy
Q.76 What is the main function of a "selectable marker" (e.g., antibiotic resistance gene) in a plasmid vector?
To increase the plasmid size for better stability
To allow identification and maintenance of cells that have taken up the plasmid
To encode the therapeutic protein directly
To act as a fluorescent reporter
Explanation - Selectable markers confer resistance to an antibiotic, so only transformed cells survive in selective media.
Correct answer is: To allow identification and maintenance of cells that have taken up the plasmid
Q.77 Which of the following best describes a "nanoparticle" used for drug delivery?
A particle with a diameter of 1–100 µm
A particle with a diameter typically less than 200 nm, designed to improve drug solubility and targeting
A large macroscopic tablet
A virus used as a vaccine
Explanation - Nanoparticles can enhance bioavailability, protect drugs from degradation, and enable targeted delivery.
Correct answer is: A particle with a diameter typically less than 200 nm, designed to improve drug solubility and targeting
Q.78 In biopharmaceutical production, what does the term "cell density" refer to?
The number of cells per unit volume of culture broth
The number of plasmids inside each cell
The mass of the bioreactor walls
The concentration of dissolved oxygen
Explanation - Cell density (cells/mL) is a key metric for monitoring growth and productivity in fermentation processes.
Correct answer is: The number of cells per unit volume of culture broth
Q.79 Which of the following is a typical reason to employ "high‑throughput screening" in the early stages of biopharmaceutical development?
To evaluate the stability of a single drug candidate under many conditions
To quickly test large libraries of variants (e.g., antibodies) for desired properties
To replace all downstream purification steps
To determine the exact 3‑D structure of a protein
Explanation - High‑throughput screening enables rapid identification of promising candidates from thousands of variants.
Correct answer is: To quickly test large libraries of variants (e.g., antibodies) for desired properties
Q.80 Which of the following is an example of a “cell‑based therapy”?
A recombinant insulin injection
CAR‑T cells engineered to target cancer cells
A viral vector vaccine
A small‑molecule kinase inhibitor
Explanation - CAR‑T therapy modifies a patient’s T cells to express chimeric antigen receptors that recognize tumor antigens.
Correct answer is: CAR‑T cells engineered to target cancer cells
Q.81 What does the term "batch record" refer to in GMP‑compliant manufacturing?
A list of all employees working in the facility
A detailed document that records every step, parameter, and observation for a specific production batch
A financial statement for the product line
A patent filing for the manufacturing process
Explanation - Batch records provide traceability and ensure that each batch meets predefined specifications.
Correct answer is: A detailed document that records every step, parameter, and observation for a specific production batch
Q.82 In the context of therapeutic protein stability, what is "aggregation"?
The process by which proteins unfold and bind together, potentially reducing efficacy and increasing immunogenicity
The synthesis of protein monomers from amino acids
The conversion of protein into nucleic acid
The binding of protein to DNA
Explanation - Protein aggregation can lead to loss of activity and heightened risk of adverse immune responses.
Correct answer is: The process by which proteins unfold and bind together, potentially reducing efficacy and increasing immunogenicity
Q.83 Which of the following best explains why "single‑use" bioprocessing components are often made of polymeric materials?
Polymers have higher thermal conductivity than metals
Polymers are inert, disposable, and reduce cross‑contamination risk
Polymers allow for higher pressures in the system
Polymers are magnetic and aid in mixing
Explanation - Single‑use polymer components (e.g., bags, tubing) are pre‑sterilized, eliminating the need for cleaning and sterilization between batches.
Correct answer is: Polymers are inert, disposable, and reduce cross‑contamination risk
Q.84 Which of the following is a primary factor influencing the choice of expression system (bacterial, yeast, mammalian) for a recombinant protein?
The color of the final product
The required post‑translational modifications and protein complexity
The geographic location of the manufacturing plant
The type of packaging used for the drug
Explanation - Complex proteins needing human‑like PTMs often require eukaryotic systems, while simple proteins can be produced in bacteria.
Correct answer is: The required post‑translational modifications and protein complexity
Q.85 What is the main purpose of "glycosylation analysis" during biopharmaceutical development?
To determine the DNA sequence of the expression vector
To assess the pattern and composition of attached carbohydrate chains, which affect efficacy and safety
To measure the electrical conductivity of the formulation
To calculate the cost of raw materials
Explanation - Glycosylation can influence protein folding, stability, immunogenicity, and biological activity.
Correct answer is: To assess the pattern and composition of attached carbohydrate chains, which affect efficacy and safety
Q.86 Which of the following best describes a "biosensor" used in bioprocess monitoring?
A device that detects specific biological molecules (e.g., glucose, lactate) and converts the signal into an electrical output
A computer program that simulates protein folding
A type of chromatography column
A sterile filter used for virus removal
Explanation - Biosensors provide rapid, real‑time measurements of metabolites, enabling tighter process control.
Correct answer is: A device that detects specific biological molecules (e.g., glucose, lactate) and converts the signal into an electrical output
Q.87 Which of the following statements about "adenoviral vectors" is true?
They integrate permanently into the host genome.
They are non‑replicating, high‑capacity vectors often used for vaccine delivery.
They cannot infect human cells.
They are derived from bacteria.
Explanation - Adenoviral vectors can carry large DNA inserts and elicit strong immune responses, making them suitable for vaccines, but they usually remain episomal.
Correct answer is: They are non‑replicating, high‑capacity vectors often used for vaccine delivery.
Q.88 In the development of a monoclonal antibody, what is meant by the term "humanization"?
Replacing the murine framework regions with human antibody sequences while retaining the antigen‑binding CDRs
Adding a human Fc region to a bacterial protein
Removing all glycosylation sites from the antibody
Converting the antibody into a small‑molecule drug
Explanation - Humanization reduces immunogenicity by making the antibody more similar to naturally occurring human antibodies.
Correct answer is: Replacing the murine framework regions with human antibody sequences while retaining the antigen‑binding CDRs
Q.89 Which of the following best explains the concept of "targeted drug delivery"?
Delivering a drug to the entire body indiscriminately
Using carriers or ligands that direct the therapeutic agent specifically to diseased cells or tissues
Increasing the dosage of a drug to achieve higher systemic exposure
Administering the drug only via intravenous injection
Explanation - Targeted delivery aims to improve efficacy and reduce side effects by concentrating the drug at the intended site of action.
Correct answer is: Using carriers or ligands that direct the therapeutic agent specifically to diseased cells or tissues
Q.90 What is the primary advantage of using "continuous perfusion" culture for monoclonal antibody production?
It eliminates the need for any downstream processing
It maintains cells at high viability and productivity, allowing steady antibody output over extended periods
It requires no monitoring of culture parameters
It produces antibodies with no glycosylation
Explanation - Perfusion continuously feeds fresh media and removes waste, keeping cells in an optimal growth phase for prolonged high‑titer production.
Correct answer is: It maintains cells at high viability and productivity, allowing steady antibody output over extended periods
Q.91 Which of the following is a characteristic feature of "RNA‑based therapeutics"?
They are highly stable at room temperature without any formulation
They rely on delivering messenger RNA (mRNA) to cells for transient protein expression
They permanently alter the genome of target cells
They function as traditional small‑molecule drugs
Explanation - mRNA therapeutics encode the desired protein, which is translated by the host cell machinery for a limited time.
Correct answer is: They rely on delivering messenger RNA (mRNA) to cells for transient protein expression
Q.92 What is the main purpose of a "process validation" study in biopharmaceutical manufacturing?
To prove that a process consistently produces a product meeting its predetermined specifications and quality attributes
To develop a new drug molecule
To design the packaging artwork
To train new employees on safety protocols
Explanation - Process validation provides documented evidence that a manufacturing process reliably yields a product of acceptable quality.
Correct answer is: To prove that a process consistently produces a product meeting its predetermined specifications and quality attributes
Q.93 Which of the following best describes "phage display" technology?
Using bacteriophages to display peptide or antibody fragments on their surface for selection of high‑affinity binders
Displaying viruses on a microscope slide
A method for measuring viral load in blood
A technique for visualizing DNA fragments on a gel
Explanation - Phage display links genotype (DNA) to phenotype (displayed protein), enabling rapid screening of large libraries.
Correct answer is: Using bacteriophages to display peptide or antibody fragments on their surface for selection of high‑affinity binders
Q.94 In a bioprocess, what does the term "critical quality attribute" (CQA) refer to?
A parameter of the manufacturing facility’s building design
A property of the drug product that must be controlled to ensure safety and efficacy (e.g., potency, purity)
The temperature of the cleanroom air
The number of employees working on a shift
Explanation - CQAs are defined during product development and are monitored throughout manufacturing to guarantee product quality.
Correct answer is: A property of the drug product that must be controlled to ensure safety and efficacy (e.g., potency, purity)
Q.95 Which of the following statements about "stable cell lines" used for biologic production is correct?
They are transiently transfected each batch and do not retain the gene of interest.
They have integrated the gene of interest into their genome, providing consistent long‑term expression.
They are always derived from bacterial hosts.
They produce only small‑molecule drugs.
Explanation - Stable cell lines ensure reproducible protein expression over many passages, crucial for large‑scale manufacturing.
Correct answer is: They have integrated the gene of interest into their genome, providing consistent long‑term expression.
Q.96 Which of the following best explains why "temperature ramping" is used during protein purification?
To change the pH of the solution rapidly
To induce selective precipitation or aggregation of impurities while keeping the target protein soluble
To sterilize the purification column
To increase the viscosity of the buffer
Explanation - Gradual temperature changes can promote impurity precipitation without denaturing the protein of interest.
Correct answer is: To induce selective precipitation or aggregation of impurities while keeping the target protein soluble
Q.97 What does the term "off‑target effects" refer to in the context of gene‑editing therapeutics?
Desired modifications at the intended genomic site
Unintended modifications at genomic locations other than the target site
The efficiency of delivering the editing tool to cells
The cost of the therapy
Explanation - Off‑target edits can cause unwanted mutations, potentially leading to safety concerns.
Correct answer is: Unintended modifications at genomic locations other than the target site
Q.98 Which of the following is a common method for sterilizing a biopharmaceutical solution without using heat?
Autoclaving at 121 °C
Filtration through a 0.22 µm membrane
Gamma irradiation
Both filtration and gamma irradiation
Explanation - Both sterile filtration (0.22 µm) and gamma irradiation are widely used to sterilize heat‑sensitive biologics.
Correct answer is: Both filtration and gamma irradiation
Q.99 Which of the following best describes the concept of "personalized medicine" in biotechnology?
Using the same drug dosage for all patients
Tailoring therapeutic interventions based on an individual’s genetic makeup, biomarkers, and disease profile
Manufacturing drugs only in small batches
Developing drugs exclusively for pediatric patients
Explanation - Personalized medicine aims to improve efficacy and reduce adverse effects by matching treatment to patient‑specific characteristics.
Correct answer is: Tailoring therapeutic interventions based on an individual’s genetic makeup, biomarkers, and disease profile
Q.100 What is the primary purpose of a "cryoprotectant" such as glycerol or DMSO in cell banking?
To increase the growth rate of cells during culture
To protect cells from damage caused by ice crystal formation during freezing
To sterilize the cell suspension
To promote viral replication
Explanation - Cryoprotectants lower the freezing point and reduce ice crystal formation, preserving cell viability during storage.
Correct answer is: To protect cells from damage caused by ice crystal formation during freezing
Q.101 Which of the following is a typical characteristic of a "small‑interfering RNA" (siRNA) therapeutic?
It integrates into the host genome permanently
It is a double‑stranded RNA molecule that triggers sequence‑specific mRNA degradation
It enhances protein translation
It acts as a vaccine adjuvant
Explanation - siRNA guides the RISC complex to complementary mRNA, leading to its cleavage and gene silencing.
Correct answer is: It is a double‑stranded RNA molecule that triggers sequence‑specific mRNA degradation
Q.102 In the context of biopharmaceuticals, what does "bioequivalence" mean?
Two drugs have the exact same chemical structure.
Two products show no statistically significant differences in rate and extent of absorption.
Two drugs are produced in the same facility.
Two products have identical shelf lives.
Explanation - Bioequivalence studies compare pharmacokinetic parameters to ensure a generic or biosimilar behaves like the reference product.
Correct answer is: Two products show no statistically significant differences in rate and extent of absorption.
Q.103 Which of the following best describes a "biologic scaffold" used in tissue engineering?
A synthetic polymer that degrades quickly
A three‑dimensional structure that supports cell attachment, growth, and tissue formation
A metallic implant used for bone repair
A small‑molecule drug that stimulates cell division
Explanation - Scaffolds provide a physical framework and can be functionalized with growth factors to guide tissue regeneration.
Correct answer is: A three‑dimensional structure that supports cell attachment, growth, and tissue formation
Q.104 Which of the following statements about "therapeutic peptides" is true?
They are always larger than 100 kDa
They often require modifications (e.g., cyclization, PEGylation) to increase stability and half‑life
They cannot be synthesized chemically
They are identical to small‑molecule drugs
Explanation - Peptides are susceptible to proteolysis; chemical modifications enhance their pharmacokinetic properties.
Correct answer is: They often require modifications (e.g., cyclization, PEGylation) to increase stability and half‑life
Q.105 What is the main purpose of using "high‑cell‑density fermentation" in recombinant protein production?
To reduce the amount of oxygen needed
To increase the overall protein yield per unit volume of bioreactor
To simplify downstream purification
To avoid the need for a promoter
Explanation - Higher cell densities provide more biosynthetic capacity, leading to greater product titers.
Correct answer is: To increase the overall protein yield per unit volume of bioreactor
Q.106 Which of the following best explains why "glycosylation" patterns can differ between CHO cells and human cells?
CHO cells lack the enzymes needed for any glycosylation
The glycosyltransferase repertoire of CHO cells is similar but not identical to that of human cells, leading to subtle differences in glycan structures
Human cells do not perform N‑linked glycosylation
Glycosylation is independent of the host cell type
Explanation - CHO cells produce human‑like glycans but may lack certain terminal sugars, requiring engineering for exact human patterns.
Correct answer is: The glycosyltransferase repertoire of CHO cells is similar but not identical to that of human cells, leading to subtle differences in glycan structures
Q.107 Which analytical technique is most suitable for detecting low‑level host‑cell‑protein (HCP) impurities in a purified biologic?
ELISA specific for HCPs
UV‑Vis spectroscopy at 280 nm
Dynamic light scattering (DLS)
Differential scanning calorimetry (DSC)
Explanation - HCP ELISAs use antibodies to sensitively detect residual host‑cell proteins that may cause immunogenicity.
Correct answer is: ELISA specific for HCPs
Q.108 What does the abbreviation "API" stand for in the pharmaceutical industry?
Active Pharmaceutical Ingredient
Automated Process Integration
Applied Protein Interface
Advanced Polymer Inhibitor
Explanation - The API is the biologically active component of a drug product; everything else (excipients, packaging) is considered inactive.
Correct answer is: Active Pharmaceutical Ingredient
Q.109 Which of the following best describes the purpose of "process analytical technology" (PAT) in biomanufacturing?
To replace all human operators with robots
To provide real‑time data that enables dynamic control of critical process parameters, ensuring consistent product quality
To design marketing strategies for new drugs
To increase the physical size of the manufacturing plant
Explanation - PAT integrates sensors, software, and statistical tools for proactive process management.
Correct answer is: To provide real‑time data that enables dynamic control of critical process parameters, ensuring consistent product quality
Q.110 In the context of vaccine platforms, what is a key advantage of "mRNA vaccines" compared with traditional protein‑based vaccines?
mRNA vaccines do not require cold storage at any temperature
They can be rapidly designed and manufactured once the pathogen’s genetic sequence is known
They integrate into the host genome, providing lifelong immunity
They do not elicit any immune response
Explanation - The flexibility of mRNA platforms allows swift adaptation to emerging pathogens, as demonstrated during the COVID‑19 pandemic.
Correct answer is: They can be rapidly designed and manufactured once the pathogen’s genetic sequence is known
Q.111 Which of the following is a typical reason to employ "glyco‑engineered" CHO cells in therapeutic antibody production?
To increase the antibody's molecular weight beyond 500 kDa
To produce antibodies with uniform, human‑like N‑glycans that improve efficacy and reduce immunogenicity
To eliminate the need for downstream purification
To make antibodies resistant to heat
Explanation - Engineered CHO cells can be programmed to produce specific glycoforms, enhancing antibody function and safety.
Correct answer is: To produce antibodies with uniform, human‑like N‑glycans that improve efficacy and reduce immunogenicity