Q.1 Which of the following best defines 'informed consent' in the context of cell and tissue engineering research?
A letter from a professor allowing participation
An agreement signed by the researcher only
A process where participants are fully educated about the study and agree to participate voluntarily
A government mandate that all studies must include consent
Explanation - Informed consent requires that participants understand the purpose, procedures, risks, and benefits of the research before agreeing to take part.
Correct answer is: A process where participants are fully educated about the study and agree to participate voluntarily
Q.2 Which international guideline provides a framework for the ethical use of human tissues in research?
The Declaration of Helsinki
The Kyoto Protocol
The Montreal Protocol
The Paris Agreement
Explanation - The Declaration of Helsinki outlines ethical principles for medical research involving human subjects, including the use of tissues.
Correct answer is: The Declaration of Helsinki
Q.3 The term 'GMP' stands for:
General Medical Practice
Good Manufacturing Practice
Genetic Modification Process
Global Medical Protocol
Explanation - GMP refers to the regulations that ensure products are consistently produced and controlled according to quality standards.
Correct answer is: Good Manufacturing Practice
Q.4 What is the main purpose of the FDA’s Investigational New Drug (IND) application?
To approve the commercial sale of a drug
To authorize the manufacturing of a drug in a facility
To allow a new drug to be tested in humans
To grant patents for drug discoveries
Explanation - An IND permits a clinical study of a new drug in human subjects after preclinical safety data have been reviewed.
Correct answer is: To allow a new drug to be tested in humans
Q.5 Which of the following is a primary ethical concern regarding the use of embryonic stem cells?
The high cost of cell culture media
The potential for tumor formation
The destruction of embryos
The lack of differentiation capacity
Explanation - Embryonic stem cell research raises concerns because obtaining the cells often involves destroying human embryos.
Correct answer is: The destruction of embryos
Q.6 What does the term 'biobanking' refer to?
The process of storing biological samples for research purposes
A type of laboratory equipment for culturing cells
A legal framework for bioinformatics data sharing
A financial investment strategy for biotech companies
Explanation - Biobanking involves the collection, processing, storage, and distribution of biological specimens for research and clinical use.
Correct answer is: The process of storing biological samples for research purposes
Q.7 Which of the following best describes 'CRISPR-Cas9'?
A technique to sequence genomes quickly
A method of measuring protein concentration
A genome editing tool that can cut DNA at specific sites
An imaging technology for cell nuclei
Explanation - CRISPR-Cas9 allows precise modifications to DNA, enabling targeted gene editing.
Correct answer is: A genome editing tool that can cut DNA at specific sites
Q.8 Which regulatory body is primarily responsible for approving medical devices in the United States?
CDC
FDA
NIH
EMA
Explanation - The Food and Drug Administration regulates the safety and efficacy of medical devices before they reach the market.
Correct answer is: FDA
Q.9 In the context of tissue engineering, what is a 'scaffold'?
A software tool for data analysis
A three-dimensional structure that supports cell attachment and growth
A type of microscope used for imaging cells
A regulatory document for clinical trials
Explanation - Scaffolds provide a physical framework that mimics natural extracellular matrix, allowing cells to organize into tissues.
Correct answer is: A three-dimensional structure that supports cell attachment and growth
Q.10 What does the acronym 'IRB' stand for?
Institutional Review Board
Integrated Research Bureau
In vitro Research Board
International Regulatory Body
Explanation - An IRB is a committee that reviews research protocols to ensure ethical standards and protect participant rights.
Correct answer is: Institutional Review Board
Q.11 Which principle is central to the Belmont Report?
Confidentiality of data
Scientific validity
Respect for persons
Commercial profit
Explanation - The Belmont Report outlines ethical principles for research, including respect for persons, beneficence, and justice.
Correct answer is: Respect for persons
Q.12 When is it ethically acceptable to use animal models in tissue engineering research?
When no alternative exists and the study has potential therapeutic benefit
Whenever the researcher wants to conduct a study
Only when the animal is a common lab species
When the animal model is cheaper than human trials
Explanation - Ethical animal research requires justification, minimal suffering, and consideration of alternatives.
Correct answer is: When no alternative exists and the study has potential therapeutic benefit
Q.13 Which of the following is a major concern when designing a clinical trial for a tissue-engineered product?
Choosing a random number generator for cell culture
Ensuring blinding and randomization to reduce bias
Using a single investigator to perform all procedures
Selecting a non-validated imaging technique
Explanation - Blinding and randomization are key to reducing bias and ensuring the reliability of clinical trial results.
Correct answer is: Ensuring blinding and randomization to reduce bias
Q.14 The principle of 'beneficence' in biomedical research means:
The research must be free of cost
The research should maximize benefits and minimize harm
The research must involve the maximum number of subjects
The research should be published in high-impact journals
Explanation - Beneficence requires that the benefits of research outweigh the risks to participants.
Correct answer is: The research should maximize benefits and minimize harm
Q.15 Which of the following statements about patent law is true for tissue-engineered products?
Patents are not allowed for biological products
Only the manufacturing process can be patented, not the product itself
Both the product and the method of producing it can be patented
Patents are automatically granted for any new cell line
Explanation - Intellectual property rights can cover both the engineered tissue product and the methods used to create it.
Correct answer is: Both the product and the method of producing it can be patented
Q.16 What is the primary goal of the 'Good Tissue Practice (GTP)' guidelines?
To reduce the cost of tissue culture
To ensure the safety, quality, and efficacy of tissue-based products
To promote the use of animal tissues in research
To standardize laboratory equipment brands
Explanation - GTP provides a framework for the manufacturing and handling of tissue products to meet regulatory standards.
Correct answer is: To ensure the safety, quality, and efficacy of tissue-based products
Q.17 Which regulatory pathway is used for products that combine drugs, biologics, and devices (combination products) in the U.S.?
FDA’s 510(k) clearance
FDA’s IND application
FDA’s BLA (Biologics License Application) pathway
FDA’s PMA (Premarket Approval) pathway
Explanation - Combination products typically require PMA, a rigorous approval process involving preclinical and clinical data.
Correct answer is: FDA’s PMA (Premarket Approval) pathway
Q.18 Why is traceability important in cell and tissue engineering?
To ensure proper marketing of the product
To keep a record of the origin, passage number, and handling of cells
To comply with tax regulations
To enable quick replication of experiments by other labs
Explanation - Traceability ensures that any batch can be identified and investigated in case of contamination or adverse events.
Correct answer is: To keep a record of the origin, passage number, and handling of cells
Q.19 What does the term 'clinical-grade' refer to in cell culture?
Cell lines that are visually bright under a microscope
Cells grown using non-sterile techniques
Cells produced under GMP conditions suitable for patient use
Cells that have been genetically modified
Explanation - Clinical-grade cells must meet stringent quality and safety requirements before being used in patients.
Correct answer is: Cells produced under GMP conditions suitable for patient use
Q.20 The ‘Three Rs’ principle in animal research stands for:
Reduce, Replace, Refine
Reduce, Reproduce, Regulate
Replace, Recycle, Restore
Regulate, Respond, Review
Explanation - The Three Rs aim to minimize animal use and suffering: reduce numbers, replace with alternatives, and refine procedures.
Correct answer is: Reduce, Replace, Refine
Q.21 Which of the following best defines 'autologous' tissue engineering?
Using donor tissue from a different species
Using tissue engineered from the patient's own cells
Using tissue engineered from stem cells harvested from a different person
Using synthetic polymers only
Explanation - Autologous means the cells or tissues are derived from the same individual, reducing immune rejection risk.
Correct answer is: Using tissue engineered from the patient's own cells
Q.22 Which of the following is an example of a 'bioartificial organ'?
A polymer scaffold seeded with hepatocytes
A synthetic bone graft
A purely mechanical heart valve
An electrical pacemaker
Explanation - A bioartificial organ combines living cells with a supportive matrix to replicate organ functions.
Correct answer is: A polymer scaffold seeded with hepatocytes
Q.23 When conducting a study involving human stem cells, which document is mandatory to ensure ethical oversight?
Informed consent form
Conflict of interest statement
Environmental impact assessment
Patent application
Explanation - Informed consent is required to confirm that participants understand and agree to the use of their cells.
Correct answer is: Informed consent form
Q.24 Which of these is a key element of a robust quality management system in cell therapy manufacturing?
A single operator performing all steps
Daily checks of temperature and humidity
Use of non-sterile gloves
Unlimited batch size
Explanation - Continuous environmental monitoring is crucial to maintain sterility and product quality.
Correct answer is: Daily checks of temperature and humidity
Q.25 What does the acronym 'GMP' stand for, and why is it important?
General Medical Practice - ensures patient privacy
Good Manufacturing Practice - ensures consistency and safety in product production
Global Market Protocol - ensures market approval
Genetic Modification Project - ensures gene editing safety
Explanation - GMP regulations guarantee that products are manufactured under controlled conditions to prevent contamination or variability.
Correct answer is: Good Manufacturing Practice - ensures consistency and safety in product production
Q.26 Which type of study design is most suitable for evaluating the efficacy of a new engineered tissue implant?
Case report
Randomized controlled trial
Cross-sectional survey
Ecological study
Explanation - RCTs provide the highest level of evidence for efficacy by comparing intervention and control groups randomly.
Correct answer is: Randomized controlled trial
Q.27 Why must cell therapy products be labeled with a 'sterility assurance level'?
To indicate how long the product can be stored
To show the level of sterility expected, ensuring safety for patients
To comply with international shipping regulations
To inform customers of the product's color
Explanation - The sterility assurance level quantifies the probability of contamination, critical for patient safety.
Correct answer is: To show the level of sterility expected, ensuring safety for patients
Q.28 Which of the following is a major ethical concern in tissue banking?
High cost of refrigeration
Potential misuse of donor tissues without proper consent
Difficulty in finding compatible donors
Long storage times leading to degradation
Explanation - Ensuring donor consent protects privacy and respects the donor's wishes regarding tissue use.
Correct answer is: Potential misuse of donor tissues without proper consent
Q.29 In the context of regenerative medicine, what is 'immunogenicity'?
The ability of a material to conduct electricity
The potential of a product to trigger an immune response
The speed at which cells divide
The mechanical strength of a scaffold
Explanation - Immunogenicity refers to how likely a material or cell product is to provoke an immune reaction in the host.
Correct answer is: The potential of a product to trigger an immune response
Q.30 Which document must be reviewed by an IRB before a study can begin?
Grant proposal
Research protocol
Company financial statements
Product marketing plan
Explanation - The IRB evaluates the protocol to ensure ethical standards and participant protections are met.
Correct answer is: Research protocol
Q.31 The ‘4 Rs’ in biomedical research are:
Reduce, Replace, Refine, Reuse
Reduce, Replace, Review, Report
Reduce, Reproduce, Refine, Regulate
Reduce, Recycle, Reuse, Rebrand
Explanation - The 4 Rs expand on the Three Rs by adding Reuse to maximize animal use and data value.
Correct answer is: Reduce, Replace, Refine, Reuse
Q.32 Which of the following best describes 'clinical trial Phase I'?
Assessing large-scale efficacy in thousands of patients
Evaluating safety and dosage in a small group of healthy volunteers or patients
Comparing new treatment to standard of care
Post-market surveillance after approval
Explanation - Phase I trials focus primarily on safety, dosage, and side effects before moving to larger efficacy studies.
Correct answer is: Evaluating safety and dosage in a small group of healthy volunteers or patients
Q.33 Which of the following is NOT a requirement for a Good Manufacturing Practice (GMP) facility?
Validated processes
Qualified personnel
Uncontrolled environment
Documentation of procedures
Explanation - GMP mandates strict control over environmental conditions to prevent contamination.
Correct answer is: Uncontrolled environment
Q.34 What does the term 'off-label use' mean in the context of tissue-engineered products?
Using a product outside of its approved indications
Using a product only for the purposes approved by the FDA
Using a product for a non-human species
Using a product in a clinical trial without IRB approval
Explanation - Off-label use refers to prescribing or administering a product for indications not formally approved by regulators.
Correct answer is: Using a product outside of its approved indications
Q.35 Which of the following best describes a 'bioprinter'?
A machine that prints 3D structures using living cells and biomaterials
A printer that prints medical reports
A device that prints tissue samples for histology
A machine that prints synthetic polymer scaffolds
Explanation - Bioprinters enable precise placement of cells within a 3D matrix, facilitating complex tissue constructs.
Correct answer is: A machine that prints 3D structures using living cells and biomaterials
Q.36 Which of the following is a principle of the '3Rs' approach to ethical animal research?
Reduce the number of animals used
Reinforce the use of animal models
Regulate the publication of results
Reproduce the same experiment multiple times
Explanation - The 3Rs (Reduce, Replace, Refine) aim to minimize animal use and suffering in research.
Correct answer is: Reduce the number of animals used
Q.37 What is a 'cell line authentication' test primarily used for?
To determine cell viability
To confirm the identity of cell lines and detect contamination
To measure cell proliferation rate
To assess differentiation potential
Explanation - Authentication ensures the correct cell identity and checks for cross-contamination, critical for reproducibility.
Correct answer is: To confirm the identity of cell lines and detect contamination
Q.38 Which of the following is a characteristic of 'allogeneic' tissue engineering?
Cells sourced from the patient themselves
Cells sourced from a donor of the same species
Cells sourced from a different species
Synthetic biomaterials only
Explanation - Allogeneic means the donor and recipient are from the same species but not genetically identical.
Correct answer is: Cells sourced from a donor of the same species
Q.39 The primary purpose of a 'preclinical study' is to:
Test a product directly in humans
Evaluate safety and efficacy in vitro or in animal models before human trials
Market the product to investors
Obtain patents
Explanation - Preclinical studies gather data on potential risks and therapeutic effects prior to clinical testing.
Correct answer is: Evaluate safety and efficacy in vitro or in animal models before human trials
Q.40 Which of the following best describes the term 'biosafety level (BSL) 2'?
Work with no biological agents
Work with moderate-risk agents requiring basic biosafety practices
Work with high-risk agents requiring specialized containment
Work with hazardous chemicals only
Explanation - BSL-2 labs handle agents that pose moderate hazards but are not extremely dangerous.
Correct answer is: Work with moderate-risk agents requiring basic biosafety practices
Q.41 In a tissue-engineered construct, why is vascularization critical?
It prevents the scaffold from collapsing
It supplies oxygen and nutrients to the cells and removes waste
It allows for easier imaging of the construct
It increases the mechanical strength
Explanation - Without vascularization, cells in the interior of a tissue construct cannot survive due to diffusion limits.
Correct answer is: It supplies oxygen and nutrients to the cells and removes waste
Q.42 Which regulatory body in the European Union is responsible for approving advanced therapy medicinal products (ATMPs)?
EMA (European Medicines Agency)
ECHA (European Chemicals Agency)
EC (European Commission)
WHO (World Health Organization)
Explanation - The EMA reviews and approves ATMPs, including cell and tissue products, in the EU.
Correct answer is: EMA (European Medicines Agency)
Q.43 Which of the following statements best reflects the concept of 'patient autonomy' in regenerative medicine?
Patients must accept any treatment proposed by doctors
Patients are passive recipients of therapy
Patients have the right to make informed decisions about their own care
Patients are responsible for manufacturing the therapy
Explanation - Patient autonomy emphasizes respecting individuals' decisions after they are fully informed.
Correct answer is: Patients have the right to make informed decisions about their own care
Q.44 What does the acronym 'ISO 13485' specify?
Quality management system for medical devices
Standards for laboratory safety
Guidelines for pharmaceutical pricing
Criteria for clinical trial reporting
Explanation - ISO 13485 sets requirements for a quality management system specific to medical device manufacturing.
Correct answer is: Quality management system for medical devices
Q.45 Why is 'cell passage number' important in cell therapy manufacturing?
It indicates how many times the cells have been frozen and thawed
It determines how many times the cells have proliferated in culture
It refers to the number of donors used
It measures the number of scaffold layers
Explanation - Higher passage numbers can lead to genetic drift, senescence, and altered functionality.
Correct answer is: It determines how many times the cells have proliferated in culture
Q.46 Which of the following is a benefit of using 3D bioprinting in tissue engineering?
It eliminates the need for scaffolds
It ensures 100% cell viability
It allows precise spatial control of cell placement and matrix composition
It reduces the cost of growth media
Explanation - 3D bioprinting enables the design of complex tissue architectures with cell and material distribution.
Correct answer is: It allows precise spatial control of cell placement and matrix composition
Q.47 Which of the following best describes 'adverse event reporting' in clinical trials?
Recording any unexpected medical occurrence in participants
Reporting only the planned outcomes
Reporting only serious injuries
Reporting only positive results
Explanation - Adverse event reporting tracks all unexpected health problems to assess safety during trials.
Correct answer is: Recording any unexpected medical occurrence in participants
Q.48 The 'In Silico' approach in cell and tissue engineering involves:
Using computer models to simulate biological processes
Using computational power for genetic sequencing
Using only software for marketing
Using virtual reality for training
Explanation - In silico modeling helps predict tissue behavior and optimize design before wet-lab experiments.
Correct answer is: Using computer models to simulate biological processes
Q.49 Which of the following is a primary ethical concern when conducting clinical trials involving pediatric patients?
Obtaining a high number of participants
Using placebo controls
Ensuring parental consent and child assent while minimizing risk
Charging higher fees for participation
Explanation - Pediatric trials require both parental consent and the child's assent, with heightened protection from harm.
Correct answer is: Ensuring parental consent and child assent while minimizing risk
Q.50 What is 'biocompatibility'?
The ability of a material to conduct heat
The ability of a material to function in a biological environment without adverse reaction
The color of the scaffold
The mechanical stiffness of a tissue
Explanation - Biocompatibility ensures that a material does not provoke inflammation or toxicity in the host.
Correct answer is: The ability of a material to function in a biological environment without adverse reaction
Q.51 Which of the following best describes 'cell banking'?
Storing cell cultures in a financial savings account
Cryopreserving cells for future use in research or therapy
Disposing of unused cell cultures
Transferring cells to a different laboratory
Explanation - Cell banking involves freezing cells under controlled conditions for long-term storage.
Correct answer is: Cryopreserving cells for future use in research or therapy
Q.52 Which of the following statements best reflects the principle of 'justice' in biomedical research?
Ensuring fair distribution of research benefits and burdens among participants
Maximizing profit for researchers
Prioritizing high-profile participants
Guaranteeing all participants receive the treatment
Explanation - Justice demands equitable selection and access to research participation and benefits.
Correct answer is: Ensuring fair distribution of research benefits and burdens among participants
Q.53 Which regulatory pathway is used in the U.S. for 'human cells, tissues, and cellular and tissue-based products' (HCT/Ps) that meet certain criteria?
FDA 510(k) clearance
FDA 510(k) exemption
Regulatory De Novo classification
Regulatory Exemption for Low-Risk HCT/Ps under 21 CFR 1271
Explanation - Certain HCT/Ps that meet defined criteria are exempt from premarket approval, reducing regulatory burden.
Correct answer is: Regulatory Exemption for Low-Risk HCT/Ps under 21 CFR 1271
Q.54 Which of the following best explains 'batch-to-batch consistency' in cell therapy manufacturing?
Each batch is produced at a different time
Every batch yields identical therapeutic efficacy and quality
Batches are stored in separate containers
Different batches are used for different patient groups
Explanation - Consistency ensures that patients receive the same product quality across all production runs.
Correct answer is: Every batch yields identical therapeutic efficacy and quality
Q.55 What is the main purpose of a 'risk assessment' in a tissue engineering project?
To identify potential hazards and mitigate them before they arise
To calculate the cost of the project
To evaluate marketing potential
To estimate the number of employees needed
Explanation - Risk assessment anticipates problems and informs safety protocols and contingency planning.
Correct answer is: To identify potential hazards and mitigate them before they arise
Q.56 Which of these is a commonly used scaffold material in bone tissue engineering?
Silicone
Polyethylene glycol
Hydroxyapatite
Polystyrene
Explanation - Hydroxyapatite is a calcium phosphate that mimics bone mineral and supports bone growth.
Correct answer is: Hydroxyapatite
Q.57 The 'Central Ethical Committee' in some countries is analogous to:
The IRB in the United States
The FDA in the United States
The WHO
The NIH
Explanation - Central Ethical Committees provide oversight for ethical aspects of research similar to IRBs.
Correct answer is: The IRB in the United States
Q.58 Which of the following best describes the concept of 'scaffold-free tissue engineering'?
Using synthetic polymers only
Using living cells that self-assemble into tissue without a physical scaffold
Using a biodegradable mesh for support
Using a natural protein matrix only
Explanation - Scaffold-free approaches rely on cell aggregates or spheroids that fuse into functional tissue.
Correct answer is: Using living cells that self-assemble into tissue without a physical scaffold
Q.59 Which of the following is an example of a 'non-invasive imaging technique' used to monitor engineered tissues in vivo?
Computed Tomography (CT)
Magnetic Resonance Imaging (MRI)
X-ray fluoroscopy
Barium swallow test
Explanation - MRI is non-invasive and provides high-resolution images of soft tissues without ionizing radiation.
Correct answer is: Magnetic Resonance Imaging (MRI)
Q.60 Why is 'sterile filtration' important in the production of cell culture media?
To remove impurities and prevent contamination of the culture
To increase the viscosity of the media
To add nutrients
To reduce the cost of production
Explanation - Sterile filtration ensures that the media is free from microbial contamination before use.
Correct answer is: To remove impurities and prevent contamination of the culture
Q.61 Which of the following is a major advantage of using induced pluripotent stem cells (iPSCs) over embryonic stem cells?
Higher differentiation potential
No ethical concerns regarding embryo destruction
Cheaper to obtain
No risk of tumor formation
Explanation - iPSCs are reprogrammed from adult cells, avoiding the use of embryos.
Correct answer is: No ethical concerns regarding embryo destruction
Q.62 The term 'manufacturing lot' refers to:
A batch of raw materials used for production
A specific quantity of a product produced under identical conditions
The number of days a product is stored
The number of machines used
Explanation - A lot is a batch produced together, ensuring traceability and quality control.
Correct answer is: A specific quantity of a product produced under identical conditions
Q.63 Which of the following best describes 'cellular senescence'?
Rapid proliferation of cells
The ability of cells to migrate
A state where cells no longer divide but remain metabolically active
Cell death by apoptosis
Explanation - Senescent cells stop dividing, which can affect tissue regeneration and product consistency.
Correct answer is: A state where cells no longer divide but remain metabolically active
Q.64 What is 'immunomodulation' in the context of tissue engineering?
Changing the immunogenic profile of a tissue construct to reduce rejection
Removing all immune cells from the construct
Using immunosuppressive drugs only
Increasing immune system activity to fight infection
Explanation - Immunomodulation aims to create a more compatible interaction between implanted tissue and host immune system.
Correct answer is: Changing the immunogenic profile of a tissue construct to reduce rejection
Q.65 Which of the following is a primary concern with 'off-target effects' of CRISPR editing?
The edited cells grow too fast
Unintended mutations in other genomic locations
The guide RNA degrades too quickly
The Cas9 protein is too large
Explanation - Off-target edits can lead to unintended changes that may be harmful or reduce safety.
Correct answer is: Unintended mutations in other genomic locations
Q.66 What does the '4th of July' refer to in regulatory terms?
The anniversary of FDA formation
The day FDA approves a new drug
It refers to 'The Fourth Amendment' of US Constitution
No regulatory meaning
Explanation - The phrase has no connection to regulatory processes; it's a cultural reference.
Correct answer is: No regulatory meaning
Q.67 Which of the following best explains the concept of 'pharmacokinetics' in cell therapy?
How cells move through the bloodstream, persist, and are cleared from the body
The cost of pharmaceutical drugs
The manufacturing process of cell products
The design of cell scaffolds
Explanation - Pharmacokinetics studies the fate of therapeutic cells within the patient over time.
Correct answer is: How cells move through the bloodstream, persist, and are cleared from the body
Q.68 Which of the following is an example of a 'companion diagnostic' for a tissue-engineered therapy?
A blood test to identify genetic markers that predict response to therapy
A device measuring blood pressure
A questionnaire about diet
An imaging scan of the brain
Explanation - Companion diagnostics identify patients likely to benefit from a specific therapeutic product.
Correct answer is: A blood test to identify genetic markers that predict response to therapy
Q.69 What is a 'clinical trial registry' used for?
Tracking financial investments in biotech companies
Publicly listing ongoing and completed clinical trials for transparency
Storing patient medical records
Cataloging laboratory equipment
Explanation - Registries like ClinicalTrials.gov provide access to trial details and results, promoting transparency.
Correct answer is: Publicly listing ongoing and completed clinical trials for transparency
Q.70 Which of the following best describes 'biosimilars'?
Products that are identical copies of a reference biological product
Generic versions of small-molecule drugs
Cell lines that produce similar proteins as reference products
Products that are biologically similar but not identical and meet regulatory equivalence
Explanation - Biosimilars are highly similar to an existing product but are not exact copies due to manufacturing complexity.
Correct answer is: Products that are biologically similar but not identical and meet regulatory equivalence
Q.71 Which of the following is a key element in 'cell line authentication' to prevent cross-contamination?
Testing for mycoplasma contamination only
DNA profiling to confirm identity
Measuring cell size by microscopy
Checking for color changes in the medium
Explanation - DNA profiling (STR analysis) verifies that cell lines remain authentic and uncontaminated.
Correct answer is: DNA profiling to confirm identity
Q.72 Which regulatory designation applies to products that are considered 'advanced therapy medicinal products' (ATMPs) in the EU?
ATMP
GMP
IND
PMA
Explanation - ATMPs include gene therapy, cell therapy, and tissue-engineered products regulated as advanced therapies.
Correct answer is: ATMP
Q.73 Which of the following is a main purpose of the 'Pharmacovigilance' system?
Monitoring the effectiveness of a drug in clinical trials only
Tracking adverse drug reactions post-marketing to ensure safety
Developing new drug formulations
Assessing the market share of a drug
Explanation - Pharmacovigilance monitors safety data after a product reaches the market.
Correct answer is: Tracking adverse drug reactions post-marketing to ensure safety
Q.74 Which of the following is a major challenge in scaling up tissue-engineered constructs for commercial production?
Ensuring uniform cell distribution in larger volumes
Reducing the color of the scaffold
Limiting the number of scientists involved
Eliminating the need for sterilization
Explanation - Large-scale production must maintain consistent cell distribution, viability, and functionality.
Correct answer is: Ensuring uniform cell distribution in larger volumes
Q.75 Which of the following is considered a 'biologic' in regulatory terms?
Synthetic polymer scaffold
Recombinant protein therapeutic
Metal implant
Silicon chip
Explanation - Biologics are products derived from living organisms, such as proteins, cells, or tissues.
Correct answer is: Recombinant protein therapeutic
Q.76 In the context of tissue engineering, what is 'mechanotransduction'?
The conversion of mechanical stimuli into biochemical signals
The process of measuring mechanical properties of tissues
The use of mechanical devices for tissue removal
The transformation of mechanical energy into electricity
Explanation - Mechanotransduction involves cells sensing mechanical forces and responding via signaling pathways.
Correct answer is: The conversion of mechanical stimuli into biochemical signals
Q.77 Which of the following best describes 'cell-based drug delivery'?
Using cells to transport therapeutic agents directly to target tissues
Injecting a drug into the bloodstream
Using a pill for systemic delivery
Using external pumps only
Explanation - Cell-based delivery harnesses cells' natural homing abilities to deliver drugs to specific sites.
Correct answer is: Using cells to transport therapeutic agents directly to target tissues
Q.78 Which of the following is a characteristic of a 'sterile product'?
Free from all microorganisms, including spores
Contains a known amount of bacterial contamination
Has a high pH value
Has a visible color change
Explanation - Sterility ensures that no viable microorganisms are present in the product.
Correct answer is: Free from all microorganisms, including spores
Q.79 What is the primary purpose of 'validation' in cell therapy manufacturing?
To confirm that manufacturing processes consistently produce the intended product
To ensure the product is expensive
To verify the color of the product
To calculate marketing budgets
Explanation - Validation demonstrates that processes are reliable and produce consistent, high-quality products.
Correct answer is: To confirm that manufacturing processes consistently produce the intended product
Q.80 Which of the following best describes the 'FDA's 'Biosimilar' pathway?
A pathway for approving generic small-molecule drugs
A pathway for approving highly similar versions of biologic drugs
A pathway for approving new vaccines only
A pathway for approving over-the-counter supplements
Explanation - The biosimilar pathway allows approval of products that are similar to an already approved biologic.
Correct answer is: A pathway for approving highly similar versions of biologic drugs
Q.81 Which of the following is a potential ethical issue with the commercialization of tissue-engineered products?
High product prices limiting access to those who need it
Increased public trust in science
Standardization of manufacturing processes
Clear regulatory guidance
Explanation - Commercialization can lead to high costs that limit patient access, raising equity concerns.
Correct answer is: High product prices limiting access to those who need it
Q.82 What is the main function of a 'clinical trial oversight committee'?
To design the trial's marketing strategy
To monitor the safety, efficacy, and ethical conduct of the trial
To manufacture the investigational product
To recruit patients for unrelated studies
Explanation - Oversight committees ensure trials meet regulatory and ethical standards throughout.
Correct answer is: To monitor the safety, efficacy, and ethical conduct of the trial
Q.83 Which of the following best describes 'cellular therapy'?
Using cells to deliver therapeutic functions to the body
Using synthetic chemicals only
Using surgical implants only
Using radiation therapy only
Explanation - Cellular therapy employs living cells to repair or replace damaged tissues and organs.
Correct answer is: Using cells to deliver therapeutic functions to the body
Q.84 Which of these is a key component of the 'Good Manufacturing Practice (GMP)' guidelines for cell therapy products?
Unregulated production processes
Documented procedures and quality control
No need for record keeping
Use of non-sterile gloves
Explanation - GMP requires rigorous documentation and QC to ensure product safety and consistency.
Correct answer is: Documented procedures and quality control
Q.85 Which of the following best explains the term 'bioreactor'?
A device that measures blood pressure
An environment that supports the growth and maintenance of cells or tissues under controlled conditions
A device used for imaging
A type of scaffold
Explanation - Bioreactors provide optimal conditions (temperature, oxygen, nutrients) for cell expansion.
Correct answer is: An environment that supports the growth and maintenance of cells or tissues under controlled conditions
Q.86 Which of the following is a typical component of a 'clinical trial protocol' for a tissue-engineered product?
Details on the marketing strategy
Study objectives, design, inclusion/exclusion criteria, and safety monitoring plans
List of competitors
Product packaging design
Explanation - The protocol outlines the scientific and operational plan for the trial.
Correct answer is: Study objectives, design, inclusion/exclusion criteria, and safety monitoring plans
Q.87 Which of the following best represents a 'regenerative medicine' application?
Using antibiotics to treat infections
Engineering a scaffold with stem cells to rebuild damaged cartilage
Applying a new surgical technique to remove a tumor
Administering a vaccine
Explanation - Regenerative medicine focuses on restoring or replacing damaged tissues using biological approaches.
Correct answer is: Engineering a scaffold with stem cells to rebuild damaged cartilage
Q.88 What does 'pharmacodynamics' study in cell therapy?
The effect of the therapeutic cells on the body
The manufacturing cost of the cells
The storage temperature of the cells
The marketing plan
Explanation - Pharmacodynamics investigates how the product exerts its therapeutic effect.
Correct answer is: The effect of the therapeutic cells on the body
Q.89 Which of the following is a major regulatory requirement for the use of human embryonic stem cells in the U.S.?
No restrictions exist
All research must be federally funded
Research must be conducted under an IND and adhere to federal safety guidelines
Only private companies can conduct such research
Explanation - The U.S. requires IND approval for clinical studies using embryonic stem cells.
Correct answer is: Research must be conducted under an IND and adhere to federal safety guidelines
Q.90 Which of the following best describes the 'fourth pillar' of biomedical research ethics?
Justice
Beneficence
Respect for persons
Non-maleficence
Explanation - The fourth pillar ensures fair distribution of research benefits and burdens.
Correct answer is: Justice
Q.91 Which of the following is a characteristic of a 'clinical-grade' cell product?
Produced without adherence to GMP
Contains known levels of contaminants
Produced under GMP with rigorous quality control and documentation
Produced only in a research laboratory
Explanation - Clinical-grade products must meet GMP standards to be safely used in patients.
Correct answer is: Produced under GMP with rigorous quality control and documentation
Q.92 Which of the following is a potential benefit of using a 'decellularized extracellular matrix' (dECM) scaffold?
It is chemically inert and does not support cell adhesion
It provides natural biochemical cues for cell adhesion and differentiation
It eliminates the need for any cell seeding
It is always synthetic
Explanation - dECM retains native ECM components that support cell behavior and tissue regeneration.
Correct answer is: It provides natural biochemical cues for cell adhesion and differentiation
Q.93 Which of the following is an example of a 'pharmacogenomic' approach in regenerative medicine?
Using a universal cell line for all patients
Personalizing cell therapies based on a patient’s genetic profile
Applying the same dosage to everyone
Ignoring genetic differences in patients
Explanation - Pharmacogenomics tailors treatment to a patient's genetic makeup to maximize efficacy.
Correct answer is: Personalizing cell therapies based on a patient’s genetic profile
Q.94 Which of the following is an essential component of the 'risk-benefit analysis' for a new tissue-engineered product?
Estimated marketing revenue
Potential patient benefits versus possible risks and adverse events
Number of scientists involved
Cost of raw materials
Explanation - Risk-benefit analysis evaluates whether the therapeutic advantages outweigh the risks.
Correct answer is: Potential patient benefits versus possible risks and adverse events
Q.95 What is the main role of the 'Institutional Biosafety Committee' (IBC)?
To review animal welfare policies
To oversee the safety of work with recombinant DNA and other biological agents
To approve clinical trial protocols
To manage grant funding
Explanation - IBC ensures that research involving potentially hazardous biological materials is conducted safely.
Correct answer is: To oversee the safety of work with recombinant DNA and other biological agents
Q.96 Which of the following best describes 'cellular senescence' in the context of cell therapy manufacturing?
Rapid cell division leading to tumor formation
Loss of replicative capacity but retention of metabolic activity
Complete cell death by apoptosis
Immediate cell differentiation
Explanation - Senescent cells stop dividing, which can affect product consistency and safety.
Correct answer is: Loss of replicative capacity but retention of metabolic activity
Q.97 Which of the following is a key element of 'clinical trial registration'?
Only reporting positive results
Publicly listing trial design, methodology, and status on a recognized registry
Keeping the trial details confidential
Avoiding publication of results
Explanation - Registration promotes transparency and reduces selective reporting bias.
Correct answer is: Publicly listing trial design, methodology, and status on a recognized registry
Q.98 Which of the following is NOT a primary goal of 'Good Manufacturing Practice' (GMP) in cell therapy?
Ensure product consistency
Reduce regulatory oversight
Maintain traceability of raw materials and products
Provide a framework for quality control
Explanation - GMP actually increases regulatory oversight to ensure safety and quality.
Correct answer is: Reduce regulatory oversight
Q.99 Which of the following best describes a 'bio-ink' in 3D bioprinting?
A type of ink used for labeling cells
A mixture of cells, biomaterials, and nutrients that can be printed to form tissue constructs
A chemical solvent for cleaning printers
A brand of 3D printers
Explanation - Bio-inks combine living cells with biomaterials to be extruded by bioprinters.
Correct answer is: A mixture of cells, biomaterials, and nutrients that can be printed to form tissue constructs
Q.100 Which of the following best explains the term 'cellular heterogeneity'?
All cells in a culture are identical
Variations in cell size and function within a culture or tissue
Cells having the same gene expression profile
Uniform distribution of nutrients
Explanation - Cellular heterogeneity refers to differences among individual cells within a population.
Correct answer is: Variations in cell size and function within a culture or tissue
Q.101 Which of the following is a requirement for the 'Quality Control' (QC) of a tissue-engineered product?
Random sampling of the product for sterility and potency tests
Only visual inspection of the product
Testing only once during production
No testing is needed for cell-based products
Explanation - QC involves sampling and testing to ensure the product meets predefined criteria.
Correct answer is: Random sampling of the product for sterility and potency tests
Q.102 Which of the following is an ethical consideration for the use of genetic editing tools such as CRISPR in therapeutic applications?
Ensuring the edits are reversible
Limiting use only to animals
Making the tools publicly available without restriction
Avoiding any safety testing
Explanation - Reversibility and controllability of edits reduce the risk of unintended, lasting changes.
Correct answer is: Ensuring the edits are reversible
Q.103 Which of the following best describes 'cellular immunogenicity'?
The ability of a cell to cause a cell-mediated immune response
The cell's resistance to antibiotics
The speed of cell division
The cell's ability to change color
Explanation - Immunogenicity refers to how a cell might trigger an immune reaction when implanted.
Correct answer is: The ability of a cell to cause a cell-mediated immune response
Q.104 Which of the following is a primary goal of 'risk mitigation' strategies in the manufacturing of cell-based products?
Increasing product cost
Identifying and controlling sources of contamination
Reducing the number of quality control steps
Delaying the manufacturing process
Explanation - Risk mitigation identifies potential hazards and implements controls to prevent them.
Correct answer is: Identifying and controlling sources of contamination
Q.105 Which of the following best characterizes a 'companion diagnostic' device?
A device used to monitor patient vitals during therapy
A tool that predicts which patients are likely to benefit from a specific therapy
A device used to sterilize cell products
A diagnostic test for unrelated diseases
Explanation - Companion diagnostics identify patient subpopulations suitable for a targeted therapy.
Correct answer is: A tool that predicts which patients are likely to benefit from a specific therapy
Q.106 Which of the following is a key component of the 'Good Cell Culture Practice' (GCCP) guidelines?
Using any type of culture media
Ensuring cell line authenticity and absence of contamination
Avoiding documentation of procedures
Using only manual pipetting
Explanation - GCCP emphasizes authenticity, sterility, and reproducibility in cell culture operations.
Correct answer is: Ensuring cell line authenticity and absence of contamination
Q.107 Which of the following is a key factor in ensuring 'scaffold biodegradability'?
The scaffold must never degrade in the body
The scaffold must degrade at a rate that matches tissue regeneration
The scaffold should be made of metal
The scaffold should be non-absorbable
Explanation - Biodegradable scaffolds are designed to degrade as new tissue forms.
Correct answer is: The scaffold must degrade at a rate that matches tissue regeneration
Q.108 Which of the following best describes 'immune privilege' in the context of transplantation?
The ability of a transplanted tissue to evade immune detection
The requirement for high-dose immunosuppression
The use of a highly immunogenic donor tissue
The necessity for genetic matching only
Explanation - Immune privilege refers to sites or tissues that naturally evade immune responses.
Correct answer is: The ability of a transplanted tissue to evade immune detection
Q.109 Which of the following is a primary advantage of using 'synthetic biomaterials' as scaffolds?
They are naturally derived
They allow precise control over mechanical properties and degradation rates
They are always biocompatible
They require no regulatory oversight
Explanation - Synthetic scaffolds can be engineered for specific properties and mass-produced consistently.
Correct answer is: They allow precise control over mechanical properties and degradation rates
Q.110 Which of the following statements best reflects the concept of 'post-market surveillance' for cell-based therapies?
Monitoring patient outcomes after the product is approved and on the market
Stopping all clinical trials after approval
Only collecting data during initial trials
Ignoring adverse events once the product is sold
Explanation - Post-market surveillance tracks safety and effectiveness in real-world use.
Correct answer is: Monitoring patient outcomes after the product is approved and on the market
Q.111 Which of the following best explains 'mechanical preconditioning' of engineered tissues?
Exposing tissues to mechanical forces before implantation to improve integration
Ignoring mechanical forces during culture
Using only static culture conditions
Applying chemical stimuli only
Explanation - Mechanical preconditioning mimics physiological forces, enhancing tissue maturation.
Correct answer is: Exposing tissues to mechanical forces before implantation to improve integration
Q.112 What is the significance of 'cell potency assays' in cell therapy development?
They measure the electrical activity of cells
They confirm the functional differentiation potential of the cells
They assess the color of the culture
They determine the cost of cell production
Explanation - Potency assays verify that cells can differentiate into the desired lineage.
Correct answer is: They confirm the functional differentiation potential of the cells
Q.113 Which of the following best represents the 'risk of tumorigenicity' in stem cell therapies?
The likelihood that the cells will die immediately
The probability that the implanted cells will form tumors
The chance of contamination with bacteria
The cost of cell culture
Explanation - Tumorigenicity refers to the risk that stem cells may give rise to malignant tumors.
Correct answer is: The probability that the implanted cells will form tumors
Q.114 Which of the following best explains the concept of 'immune rejection' in the context of allogeneic tissue implants?
The implant becomes accepted without any immune response
The host immune system identifies the implant as foreign and attacks it
The implant never interacts with the immune system
The implant causes immunodeficiency
Explanation - Allogeneic implants can trigger an immune response leading to rejection.
Correct answer is: The host immune system identifies the implant as foreign and attacks it
Q.115 Which of the following is a primary challenge in the 'scalability' of tissue-engineered products?
Ensuring uniform cell distribution and maintaining quality control across large batches
Finding enough color dyes for the scaffold
Increasing the number of research students
Reducing regulatory oversight
Explanation - Scaling up while preserving product consistency is a major hurdle.
Correct answer is: Ensuring uniform cell distribution and maintaining quality control across large batches
Q.116 Which of the following best describes 'clinical efficacy'?
The theoretical potential of a therapy based on laboratory data
The proven ability of a therapy to produce the intended therapeutic effect in patients
The cost-effectiveness of a therapy
The ease of manufacturing the therapy
Explanation - Clinical efficacy is demonstrated through clinical trials showing benefit to patients.
Correct answer is: The proven ability of a therapy to produce the intended therapeutic effect in patients
Q.117 Which of the following is a key ethical principle in regenerative medicine that addresses the use of resources?
Justice
Non-maleficence
Beneficence
Respect for persons
Explanation - Justice concerns fair distribution and equitable allocation of limited resources.
Correct answer is: Justice
Q.118 Which of the following best explains the term 'cell therapy dose'?
The number of cells administered to a patient per unit of volume
The weight of the cell culture
The volume of the cell suspension
The duration of cell culture
Explanation - Cell dose refers to the quantity of cells given to achieve therapeutic effect.
Correct answer is: The number of cells administered to a patient per unit of volume
Q.119 Which of the following is a requirement for the 'sterile filtration' of cell culture media?
Using a filter with a pore size large enough to allow cells to pass
Using a filter with a pore size small enough to retain bacteria while allowing media components to pass
Using a filter only for visual inspection
Using a filter at a temperature above 50°C
Explanation - Sterile filtration removes microbial contaminants without affecting the media.
Correct answer is: Using a filter with a pore size small enough to retain bacteria while allowing media components to pass
Q.120 Which of the following is a potential benefit of using '3D bioprinting' in regenerative medicine?
It eliminates the need for cells
It enables precise spatial arrangement of cells and biomaterials to mimic natural tissue architecture
It reduces the cost of cell culture
It replaces the need for clinical trials
Explanation - 3D bioprinting allows creation of complex, layered structures with controlled cell placement.
Correct answer is: It enables precise spatial arrangement of cells and biomaterials to mimic natural tissue architecture