BACE Exam Categories & Subcategories

Technical Skills & Applications

Technical Skills & Applications covers the foundational techniques used in biotechnology workplace settings. It includes understanding and applying methods such as aseptic technique, cell culture, DNA isolation, and various assays. The focus is on both the theoretical principles and the practical application of these techniques, including the use of advanced equipment and procedures such as polymerase chain reaction (PCR), gel electrophoresis, and chromatography.

• Discuss current techniques used in biotechnology and their applications
• Describe the proper use of microscopes
• Discuss cell staining, and distinguish between gram-positive/negative cells
• Describe the process of culturing microorganisms and tissues using aseptic technique
• Discuss the differences between sterilization, decontamination, and disinfection
• Understand the principle by which a pH meter works
• Explain the principles of spectrophotometry, including Fourier-transform infrared (FT/IR) spectrophotometry
• Understand the basic principle of the Beer-Lambert law
• Discuss methods of chromosomal and plasmid DNA isolation, purification, and quantification
• Discuss gel electrophoresis techniques, including agarose and polyacrylamide gel electrophoresis (PAGE)
• Understand how restriction enzymes are used
• Describe recombinant DNA and cloning techniques
• Describe the mechanism of PCR, including the theory and practical use of conventional and real-time PCR (qPCR) thermal cyclers
• Discuss protein expression in model organisms
• Discuss methods of molecule/protein isolation, purification, and quantification
• Understand the principles of enzyme-linked immunosorbent assay (ELISA) and other immunoassays
• Understand molecular diagnostics techniques and their applications
• Discuss assay development and validation
• Understand the principles and applications of flow cytometry and cell sorting
• Discuss the principles of centrifugation and its applications
• Understand the basics of chromatography techniques
• Discuss transformation and transfection of model organisms
• Understand applications of lab automation and robotics in biotechnology
• Explain the importance of equipment calibration for accurate measurements
• Discuss how validation ensures a process or equipment operates as intended
• Discuss the principles and applications of laminar flow in a cleanroom or manufacturing environment

Safety & Workplace Culture

Safety and Workplace Culture emphasizes the importance of safety, ethics, and proper behavior in the biotechnology workplace. It includes understanding and following safety protocols, using personal protective equipment (PPE), handling hazardous materials, and responding to emergencies. It also covers the ethical considerations in biotechnology, workplace behaviors, and compliance with regulations enforced by agencies such as the Occupational Safety and Health Administration (OSHA).

• Discuss ethics and bioethics in the workplace and society
• Describe appropriate workplace behaviors
• Identify proper workplace safety behaviors
• Identify safety symbols
• Identify and explain proper use of safety equipment
• Identify and properly use PPE
• Exercise proper safety protocols
• Describe proper handling of biological and hazardous waste
• Explain the importance of posting and complying with signage
• Describe procedures for safe handling and storage of chemicals
• Derive information from safety data sheets (SDS)
• Discuss key OSHA regulations applicable to biotechnology workplaces
• Describe proper lockout/tagout procedures for machinery and equipment
• Describe emergency response procedures for fires, chemical spills, or other incidents
• Discuss the process for reporting safety concerns and hazards, including near misses
• Discuss the importance of proactive safety communication
• Understand the importance of comprehensive training and safety training in biotechnology workplaces
• Properly label items, including solutions, buffers, Petri plates, samples, and products

Regulation & Quality

Regulation & Quality involves understanding the regulatory environment and quality practices associated with the development, manufacture, and testing of biotechnology-based products and processes. It covers the roles of regulatory agencies such as the Food and Drug Administration (FDA), current Good Laboratory Practices (CGLP), current Good Manufacturing Practices (CGMP), and Good Documentation Practices (GDocP). It also includes knowledge of the processes involved in product development, regulatory approval, departmental roles, and maintaining data integrity and security.

• Discuss regulatory agencies governing the manufacture and distribution of biotechnology-derived products
• Outline the role of various departments in a company, including Research and Development (R&D), Quality Assurance (QA), Quality Control (QC), and Manufacturing
• Understand the purpose of CGLP in non-clinical studies
• Understand the purpose of CGMP
• Follow practices associated with regulatory compliance
• Discuss key components of GDocP, including contemporaneous documentation, controlled documents, and approvals
• Identify the proper use and essential elements of CGMP documents, such as Standard Operating Procedures (SOP), batch records, logs, and deviation reports
• Explain the objectives of research and development with the goal of launching an FDA regulated product.
• Explain the FDA approval process for regulated products
• Outline the manufacturing process in bioprocessing and production facilities
• Discuss Upstream (USP) and Downstream Processing (DSP), including the key steps and equipment involved in each process
• Describe Environmental Monitoring (EM) in a controlled space
• Understand the importance of audits and Corrective and Preventive Actions (CAPA) to ensure compliance and continuous improvement
• Discuss Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles and FDA guidelines on data integrity and compliance
• Discuss strategies for maintaining security of sensitive data and intellectual property
• Describe the significance of Health Insurance Portability and Accountability Act (HIPAA) compliance and the protection of personal health information

Biochemistry & Molecular Biology

Biochemistry & Molecular Biology focuses on the molecular and biochemical principles that underpin biotechnology. It includes understanding DNA structure and function, gene expression, protein synthesis, enzyme activity, and cell biology. It also covers processes and techniques related to molecular biology and protein expression, such as monoclonal antibody production, immunotherapy, and the role of mRNA in therapeutics.

• Understand the chemistry of molecules and macromolecules
• Describe DNA structure and function
• Describe transcription
• Describe translation and gene expression
• Describe protein structure and function
• Explain how enzymes function and affect reaction rates
• Understand cell settling and centrifugation techniques
• Discuss proper techniques for mixing solutions and preparing reagents
• Understand the general physiology of cells
• Explain the interaction between cells, and between cells and their environment
• Understand the genetics of model organisms
• Discuss monoclonal antibody (mAb) production and applications
• Understand the role of mRNA in cellular function and therapeutics
• Discuss immunotherapy types and applications, such as chimeric antigen receptor T-cell (CAR-T) and mAb

Biotechnology Skills

Biotechnology Skills centers on technical skills essential for quality work. It includes accurately measuring liquids and solids, preparing solutions, performing serial dilutions, and using standard equipment such as centrifuges, spectrophotometers, and biosafety cabinets. The focus is on mastering these practical skills to ensure precise and reliable outcomes.

• Accurately measure liquids using micropipettes and serological pipets
• Accurately measure mass using electronic balances
• Properly prepare solutions and buffers
• Properly measure and adjust the pH of a solution with a pH meter
• Properly perform a serial dilution
• Identify and properly handle reagents
• Demonstrate proper aseptic/sterile technique
• Demonstrate proper culturing of microorganisms
• Describe the proper use of a centrifuge
• Describe the proper use of a spectrophotometer
• Demonstrate an understanding of how calibration and validation are critical to producing reliable, consistent results
• Describe the proper use and maintenance of biosafety cabinets (BSC)
• Demonstrate proper use of electrophoresis equipment
• Discuss the role and impact of automation in the biotechnology industry
• Use 24-hour time correctly

Applied Mathematics

Applied Mathematics covers the mathematical skills needed to perform common bioscience workplace calculations and data analysis. It includes using scientific notation, significant digits, metric conversions, making dilutions, calculating weight and volume measurements for buffer and media prep, graphing data, and performing statistical analyses. These skills are crucial for designing experiments, preparing reagents and solutions, and interpreting results.

• Use scientific notation correctly
• Use significant digits correctly
• Understand and use mathematical symbols
• Understand and use fractions
• Use metric measurements and perform metric unit conversions
• Generate a graph using collected data
  • Properly plot data
  • Interpret data
  • Generate a standard curve
• Perform calculations for serial dilutions
• Perform calculations using dilution ratios
  • Solve Dilution Factor calculations
  • Solve Molarity solution calculations
  • Solve Volume/Volume (V/V) solution calculations
  • Solve Weight/Volume (W/V) solution calculations
• Describe the relationship between pH measurements and the logarithmic scale
• Apply basic statistical techniques such as mean, median, mode, and standard deviation to analyze data

Standard Equipment

Standard Equipment focuses on the proper identification, use, and maintenance of standard equipment. It includes understanding the safe operation of micro and macro pipettes, balances, pH meters, centrifuges, and other essential tools. Mastery ensures an aptitude for the accurate and safe handling of equipment, and critical parameters such as calibration, maintenance, and validation.

• Identify common glassware and equipment
• Demonstrate proper and safe use of
  • micropipettes & serological pipets
  • electronic balances
  • pH meters
  • stirrers/shakers
  • vortexers
  • water baths
  • autoclaves
  • BSC
  • fume hoods
  • centrifuges
  • spectrophotometers
  • microscopes
  • electrophoresis equipment
  • incubators
  • heat/cool blocks
  • chromatography equipment

Experimental Design & Data Analysis

Experimental Design & Data Analysis involves understanding how to design experiments, analyze data, and communicate findings effectively. It covers the use of controls, maintaining a laboratory notebook, applying statistical methods, and adhering to the principles of Responsible Conduct of Research (RCR). The focus is on ensuring that experiments are well-designed, data is accurately interpreted, and results are clearly communicated.

• Read, interpret, and draw conclusions from technical material, test records, and specification sheets
• Discuss good experimental design, including the proper use of controls
• Explain how to maintain a laboratory notebook
• Analyze and interpret data, including the use of statistical analysis
• Understand and apply the principles of RCR
• Demonstrate proper implementation of data integrity principles
• Effectively communicate scientific findings
• Understand applications of Principal Component Analysis (PCA)

• Identify and analyze sources of error in assay results
• Discuss the role of sample size and replication for study design