Exam Glossary

Agarose Gel Electrophoresis: A method used to separate DNA or RNA molecules based on their size by applying an electric field to an agarose gel matrix. The agarose gel acts as a sieve, allowing smaller molecules to move faster through the gel while larger molecules move more slowly, enabling the separation and analysis of nucleic acids.

Aseptic Technique: A set of practices used to prevent contamination by pathogens or unwanted microorganisms during procedures, crucial for maintaining sterile conditions in cell culture and other sensitive processes.

Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA): Principles that ensure data integrity in regulated environments, ensuring that data is reliable, accurate, and trustworthy.

Autoclave: A device used to sterilize equipment and materials using high-pressure steam, commonly used in laboratory, industrial, and medical settings to ensure that tools and materials are free of microbial contamination.

Automation: The use of technology to automate biotechnology processes, increasing efficiency and reducing human error, commonly employed in high-throughput screening and sample processing.

Batch Record: A controlled document that contains instructions for manufacturing a regulated product. It also captures contemporaneous data relevant to the manufacture of that product.

Beer-Lambert law (also written Beer’s Law): A principle that describes the linear relationship between the concentration of a solute in a solution and the absorbance of light at a particular wavelength, used in quantitative spectrophotometry.

Buffer: A solution that resists changes in pH when small amounts of acid or base are added, commonly used in biological experiments to maintain a stable pH environment.

Biosafety Cabinet (BSC): Enclosed, ventilated workspace designed to protect the user, the product, and the environment from exposure to biohazards and contamination.

Calibration: The process of adjusting and standardizing the measurements of an instrument or device to ensure accuracy and reliability, which is essential for maintaining data integrity.

Cell Culture: The process of growing cells in a controlled, artificial environment, typically using a nutrient-rich culture medium, for research, production of biologics, or other biotechnological applications.

Cell Sorting: A method of separating cells based on specific characteristics, often using flow cytometry to isolate particular cell types for further study or therapeutic use.

Cell Staining: The process of applying dyes to cells or tissues to enhance contrast under a microscope, enabling the visualization of cellular components, often used in identifying cell structures or distinguishing between cell types.

Centrifuge: A machine that spins samples at high speeds to separate components based on their density, commonly used to isolate cells, organelles, or macromolecules in biological research.

Chromatography: A technique for separating and analyzing the components of a mixture based on their different interactions with a stationary phase and a mobile phase, commonly used in protein purification, drug testing, and biochemical analysis.

Cloning Techniques: Methods used to create copies of DNA fragments, cells, or organisms, often used in research, therapeutic applications, and genetic engineering.

Corrective and Preventive Actions (CAPA): A systematic approach used in manufacturing and quality management to identify, investigate, and correct the root causes of problems to prevent their recurrence. Corrective actions address immediate issues, while preventive actions focus on eliminating potential future problems.

Current Good Manufacturing Practices (CGMP): Regulations enforced by the FDA to ensure that products are produced in a consistent and controlled manner according to quality standards, covering all aspects of manufacturing.

DNA Isolation: The process of extracting DNA from cells or tissues, allowing it to be used for various downstream applications such as PCR, sequencing, or cloning.

Downstream Processing (DSP): The phase that follows upstream processing in bioprocessing, involving the purification and recovery of the product from the complex mixture produced during upstream processing. It includes techniques such as filtration, chromatography, and crystallization to isolate and purify the final product.

Electrophoresis Equipment: Instruments used to perform gel electrophoresis, a technique for separating DNA, RNA, or proteins based on their size and charge.

Enzyme-linked Immunosorbent Assay (ELISA): A plate-based assay technique used to detect and quantify specific proteins, antibodies, or hormones, widely used in diagnostics and research.

Environmental Monitoring (EM): Involves the systematic collection of data to detect contaminants in a controlled environment, such as a cleanroom or manufacturing facility. It ensures that the environment meets specified cleanliness and safety standards, crucial for maintaining product quality in industries like biotechnology and pharmaceuticals.

Flow Cytometry: A technology used to analyze the physical and chemical characteristics of cells or particles as they pass through a laser, allowing for the measurement of various cellular properties, including size, complexity, and fluorescence.

Food and Drug Administration (FDA): A regulatory agency of the United States Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, and cosmetics. In the biotech industry, the FDA regulates the development, testing, manufacturing, and approval of biotechnological products, including pharmaceuticals, vaccines, and diagnostic tools.

Fourier-transform Infrared (FT/IR) Spectrophotometry: A type of infrared spectroscopy that collects spectral data over a wide range of wavelengths simultaneously, used to identify chemical bonds and molecular structures.

Gel Electrophoresis: A method used to separate mixtures of DNA, RNA, or proteins based on their size and charge by applying an electric field to a gel matrix, causing molecules to migrate through the gel.

Good Documentation Practices (GDocP): Guidelines for accurately recording and maintaining documents, ensuring they are complete, consistent, and easily retrievable, which is critical in regulated environments.

Good Laboratory Practices (GLP): A set of principles intended to ensure the quality and integrity of non-clinical laboratory studies, regulated by agencies like the FDA.

Gram Staining: A differential staining technique that distinguishes between Gram-positive and Gram-negative bacteria based on the properties of their cell walls, used for bacterial classification and diagnosis.

Health Insurance Portability and Accountability Act (HIPAA): U.S. legislation that provides data privacy and security provisions to safeguard medical information, ensuring that personal health information is protected.

Immunoassay: A biochemical test that measures the presence or concentration of a substance in a solution using the reaction of an antibody or antibodies to its antigen.

Immunotherapy: A type of treatment that uses the immune system to fight diseases such as cancer, often involving the use of monoclonal antibodies, CAR-T cells, or other immune-modulating therapies.

Incubator: A device used to maintain a controlled environment, typically with regulated temperature and humidity, for the growth and development of microorganisms or cell cultures.

Laminar Flow: A smooth, uniform flow of air in one direction, typically used in cleanrooms or biosafety cabinets to prevent contamination during sensitive procedures.

Manufacturing: The department within a drug manufacturing company responsible for producing the product. This department is also sometimes referred to as "Production."

Micropipette: Precision instrument used to measure and transfer small volumes of liquid, essential for accurate experimental work.

Microscopy: The use of microscopes to view and analyze structures that are too small to be seen with the naked eye, such as cells, tissues, or microorganisms.

Monoclonal Antibody (mAb): Antibodies that are identical and produced by a single clone of cells, used in various therapeutic and diagnostic applications due to their specificity for a particular antigen.

Occupational Safety and Health Administration (OSHA): A regulatory agency of the United States Department of Labor that is responsible for ensuring safe and healthy working conditions for employees by setting and enforcing workplace safety standards. OSHA provides training, outreach, education, and assistance to employers and workers, and it enforces compliance through inspections and penalties.

Personal Protective Equipment (PPE): Equipment worn to minimize exposure to hazards that can cause serious workplace injuries or illnesses, including items such as gloves, masks, goggles, and lab coats.

Polyacrylamide Gel Electrophoresis (PAGE): A technique used to separate proteins or smaller DNA/RNA fragments based on their size and charge by applying an electric field to a polyacrylamide gel. The polyacrylamide gel provides a high-resolution medium for the separation of molecules, making it particularly useful for protein analysis and the study of small nucleic acid fragments.

Polymerase Chain Reaction (PCR): A technique used to amplify small segments of DNA by generating thousands to millions of copies of a particular DNA sequence, often used in molecular biology for various applications such as cloning, gene expression analysis, and genotyping.

Principal Component Analysis (PCA): A statistical method used to reduce the dimensionality of data while preserving as much variance as possible, often used in data analysis to simplify complex datasets.

Quality Assurance (QA): The department within a drug manufacturing company responsible for ensuring compliance with CGMP. QA reviews and approves documentation, oversees personnel training, and has the ultimate authority to release or reject a product.

Quality Control (QC): The department within a drug manufacturing company responsible for performing all required testing to ensure that the final product meets its specifications.

Reagent: A substance or compound that is added to a system to cause a chemical reaction or test for the presence of another substance, widely used in experiments.

Real-Time PCR (also known as quantitative PCR, qPCR): A laboratory technique used to simultaneously amplify and quantify a targeted DNA molecule. It allows the detection of the amount of a specific DNA sequence in real-time as the amplification process proceeds, typically using fluorescent markers that emit signals in proportion to the amount of DNA.

Recombinant DNA: DNA molecules that are artificially created by combining DNA from different organisms, used in genetic engineering to express new genes in host cells.

Research and Development (R&D): Refers to the process or department through which companies and organizations develop new products, technologies, or processes, and improve existing ones. In the biotech industry, R&D involves scientific research to discover new biological insights, develop innovative therapies, improve manufacturing processes, and create new biotechnological products such as drugs, vaccines, and diagnostic tools.

Responsible Conduct of Research (RCR): The ethical and professional standards that guide researchers in the planning, conduct, and reporting of research. It encompasses principles such as honesty, accuracy, efficiency, and objectivity in scientific work. In the biotech industry, RCR is critical for ensuring the integrity of research processes, including the proper handling of data, ethical treatment of human and animal subjects, and the transparent reporting of research findings.

Restriction Enzyme: A protein that cuts DNA at a specific sequence, used in molecular cloning, genetic engineering, and various molecular biology applications to manipulate DNA.

Safety Data Sheet (SDS): A document that provides information on the properties of a chemical substance, including handling, storage, and emergency measures, required by OSHA for hazardous chemicals.

Serial Dilution: A stepwise dilution of a substance in solution, used to reduce the concentration of cells, bacteria, or viruses, making it easier to measure or quantify them.

Spectrophotometer: An instrument used to measure the intensity of light absorbed by a sample, used in quantifying nucleic acids, proteins, and other molecules.

Standard Curve: A graph used in quantitative analysis that plots known concentrations of a substance against their corresponding measurement signals, allowing for the determination of unknown concentrations in samples.

Standard Operating Procedure (SOP): Detailed, written instructions to achieve uniformity in performing specific functions, essential for ensuring consistency and compliance in laboratory and manufacturing processes.

Sterilization: The process of eliminating all forms of life, including microorganisms, from an object or environment, usually achieved through heat, chemicals, or radiation.

Test Record: A controlled document that provides instructions for testing a regulated product after its production. It also captures contemporaneous data relevant to the identity, safety, efficacy, potency, purity, and quality of the product.

Transfection: The process of introducing nucleic acids (DNA or RNA) into eukaryotic cells, often used in research to study gene function and protein expression.

Transformation: The genetic alteration of a cell resulting from the direct uptake and incorporation of exogenous genetic material, typically used in bacteria to introduce new genes.

Upstream Processing (USP): Refers to the initial phase of bioprocessing where biological materials (such as cells or microbes) are prepared, grown, and optimized to produce a desired product, such as proteins or other biomolecules. This phase often includes cell culture, fermentation, and optimization of growth conditions.

Validation: The process of proving that a method, process, or piece of equipment consistently produces results that meet predetermined criteria, essential for ensuring quality and reliability in biotechnology.

Vortexer: A device used to mix small vials of liquid quickly and thoroughly by creating a vortex, commonly used in sample preparation.

Water Bath: Equipment that uses heated water to incubate samples at a constant temperature over a period of time, often used in biological and chemical experiments.