Biotechnology Standards and Skills

Skills:

1. Describe the contributions of biotechnology professionals in various sectors such as healthcare, agriculture, environmental science, and industry.
2. Trace the historical development of biotechnology, including significant milestones and breakthroughs, e.g., discovery of DNA, the first recombinant DNA molecule, and the development of the Polymerase Chain Reaction (PCR).
3. Explore the role of biotechnology in promoting environmental sustainability and addressing environmental challenges through bioremediation, biofuels, waste management, conservation efforts, and environmental monitoring.

Skills:

1. Identify and explain the main fields of biotechnology and the products they generate, including cell and gene therapies, biopharmaceuticals, mRNA technologies, and vaccines.
2. Describe the life cycle of products from research and development to production and commercialization.
3. Explain the implications of new information for both current and future problem-solving and decision-making.
4. Demonstrate the use of scientific rules and methods to solve problems using techniques such as PCR, genetic engineering, and cell culture.
5. Apply techniques such as molecular cloning, bioinformatics, and protein engineering in laboratory settings.
6. Examine the social, legal, and ethical challenges that impact the use and development of biotechnological applications.
7. Evaluate broader ethical concerns, such as patient consent and data privacy.

Skills:

1. Explain manufacturing process management techniques such as process optimization, quality control, and resource management.
2. Explain biomanufacturing lean techniques as they pertain to improved efficiency, reduction of waste, and increased productivity.
3. Explain the operation of biomanufacturing systems, including how changes in conditions, processes, and environmental factors influence outcomes.
4. Analyze the industrial applications and significance of biotechnological processes such as fermentation, mixing and aeration, bioreactor operations, and downstream processing used to produce and purify biotechnology products.
5. Explain how process control data is used to monitor and adjust processes to ensure product quality and compliance with specifications and regulations.
6. Evaluate a product to verify that it meets specifications and regulations.
7. Utilize principles of total quality management to ensure continuous improvement and quality assurance.
8. Implement validation procedures to ensure processes and products meet industry standards and regulatory requirements.
9. Describe the role of feedback and control loop systems in maintaining process stability and product quality in biomanufacturing.
10. Develop a comprehensive product development plan for a biotechnology product, including feedback mechanisms and control loops.

Skills:

1. Explain the history of pharmaceutical regulations and the Food and Drug Administration (FDA).
2. Explain the organization of the FDA, e.g., the roles of Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
3. Explain the life cycle of medical products (e.g., discovery through clinical trials, New Drug Application (NDAs), Investigational New Drug (INDs).
4. Explain current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) regulations, including their purpose, key components, and requirement in biomanufacturing and laboratory settings.
5. Explain how environmental monitoring is used to detect and control contaminants and ensure compliance with cGMP and GLP standards.
6. Identify and explain the concept of Critical Quality Attributes (CQAs) and their role in determining the quality and effectiveness of biotechnology products.
7. Explain how Critical Process Parameters (CPPs) are identified, monitored, and controlled to ensure consistent product quality.
8. Identify and describe the regulatory agencies at the local, state, and federal levels.
9. Explain the roles of the Institutional Biosafety Committee (IBC) and the Institutional Animal Care and Use Committee (IACUC).
10. Explain United States Department of Agriculture (USDA) and Public Health Service (PHS) Policy on the humane care and use of laboratory animals and the roles of the American Association for Laboratory Animal Science (AALAS) and Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC).
11. Describe the procedures for ensuring product safety, including risk assessment and mitigation strategies.
12. Explain the processes and criteria for evaluating the efficacy of biomanufacturing products, including testing and validation methods.
13. Understand international regulations and guidelines, e.g., EMA and WHO guidelines.
14. Evaluate the regulatory challenges posed by emerging technologies like CRISPR and synthetic biology.

Skills:

1. Apply 5S components (Sort, Set in Order, Shine, Standardize, Sustain) in laboratory settings to enhance organization, safety, and productivity.
2. Demonstrate basic lab management skills, including inventorying supplies, ordering required materials, and scheduling work functions.
3. Apply compliant documentation practices in accordance with cGMP and GLP standards, including signatures, dating, use of indelible ink, and witnessing requirements.
4. Document assay procedures and results and evaluate the results, e.g., determine amount of analyte in quantitative assay.
5. Maintain accurate laboratory records of experiments, equipment usage, and safety inspections.
6. Utilize various documentation methods, including logbooks, computer systems, and forms, to document lab support functions and equipment operations, such as those for autoclaves, pH meters, incubators, and freezers.
7. Apply regulatory standards from relevant agencies, e.g., OSHA, EPA, Center for Disease Control and Prevention (CDC).
8. Analyze the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and interpret Safety Data Sheets (SDS) for chemical substances.
9. Understand biosafety levels (BSL) and their requirements.
10. Demonstrate aseptic techniques and proper handling of biological materials using a biological safety cabinet and explain the principles of maintaining sterility in laboratory environments.
11. Describe procedures for dealing with biological spills and contamination.
12. Explain the concept and importance of sterile welding in maintaining clean room environments and its role in biomanufacturing and laboratory settings.
13. Identify various methods used in clean room sterilization and their applications.
14. Demonstrate the operation of an autoclave and explain its role in maintaining sterile technique.
15. Demonstrate sterilizing reagents, solutions, and media properly according to established procedures.
16. Demonstrate cleaning and sterilizing glassware and counters to meet laboratory procedures.
17. Demonstrate cleaning and maintenance of equipment according to manufacturer’s specifications.
18. Identify, use, and store laboratory equipment, e.g., pipettes, centrifuges, autoclaves.

Skills:

1. Accurately calculate measurements, including unit conversions and molarity, and prepare various types of solutions.
2. Determine correct amounts of reagents and media for formulations and dilutions.
3. Formulate solutions with precise percent, molar, and molal concentrations.
4. Conduct dilutions and calculate the concentrations of the resulting solutions.
5. Execute serial dilutions and determine the final concentrations.
6. Use filtration or autoclaving methods to prepare agar plates and broths.
7. Label and store reagents, solutions, and media according to established procedures.
8. Calculate dosage levels based on mg/kg or ml/kg.
9. Calculate quantities and parameters for product processing and quality control.
10. Perform accurate and precise measurements of volume, pH levels, and temperature.
11. Achieve accurate and precise weight measurements.
12. Calibrate and maintain instruments such as balances, pH meters, thermometers, pipettes, and spectrophotometers.
13. Conduct spectrophotometric measurements with acceptable accuracy and precision.
14. Record, compute, and interpret experimental data, including determining growth rates and performing related calculations for cell cultures.
15. Create graphs and analyze data using spreadsheet software.

Skills:

1. Identify, describe, and use the components of a microscope.
2. Differentiate between the different types of microscopes and describe their uses, including compound, inverted, scanning electron, fluorescent, and stereo.
3. Demonstrate proper cleaning technique for the microscope and lenses to maintain functionality and prevent damage.
4. Create and prepare wet mount slides and slides with cross-sections for microscopic examination.
5. Apply staining techniques to observe and analyze cell morphology.
6. Utilize a hemocytometer for accurate cell counting.
7. Identify and describe functions of cellular organelles.

Skills:

1. Demonstrate the ability to isolate DNA from samples using appropriate protocols.
2. Apply spectrophotometric or fluorometric methods to measure DNA concentration and purity.
3. Conduct enzyme-linked immunosorbent assays (ELISA) to detect and quantify proteins or antibodies.
4. Execute Western blotting to detect specific proteins in a sample.
5. Use microscopy techniques to visualize protein structures and cellular components.
6. Conduct UV-Vis Spectroscopy to measure protein concentration and monitor purity.
7. Perform centrifugation to separate proteins based on density.
8. Measure pH levels to ensure optimal conditions for protein purification.
9. Conduct DNA fingerprinting for genetic analysis and comparison.
10. Execute polymerase chain reaction (PCR) to amplify DNA segments.
11. Apply gram staining techniques to differentiate bacterial species.
12. Apply techniques such as Bradford or BCA assays to quantify protein levels.
13. Measure enzyme activity using assays appropriate for the enzyme in question.
14. Perform SDS-PAGE and agarose gel electrophoresis to separate proteins and nucleic acids.
15. Employ various chromatography techniques (size exclusion, affinity, HIC, ion exchange) for separation and analysis of biomolecules.
16. Analyze and differentiate between various chromatography methods based on their principles and applications.
17. Implement aseptic techniques to prevent contamination, including decontamination and proper disposal of waste.
18. Establish clonal cultures, culture bacteria, and identify bacterial species using staining and DNA analysis.
19. Perform bacterial transformation with plasmids and explain transformation protocols for plant and mammalian cells.
20. Maintain and preserve animal cell cultures through techniques such as cryopreservation.
21. Prepare and sterilize plant explants, monitor growth stages, and transfer plantlets to appropriate media.
22. Observe and document cell cultures using inverted microscopes.
23. Assess the viability of cells in culture using appropriate assays.
24. Explain the applications of cells in various biotechnological fields, including cancer research and regenerative medicine.
25. Apply filtration methods to separate particles from liquids or gases.

Skills:

1. Describe how High-Performance Liquid Chromatography (HPLC works), its applications in protein separation and purification, and its importance in biotechnology.
2. Explain the principles behind Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) and its role in identifying and determining the mass of proteins.
3. Prepare and analyze cell lysates for protein content and purification.
4. Discuss the functionality of AKTA systems in automated protein chromatography and their role in biomanufacturing.
5. Explain how Tangential Flow Filtration (TFF) is used for protein concentration and purification, and its principles and applications.
6. Describe various separation techniques for isolating proteins, understanding their principles and how they are applied in biotechnology.