BACE Practice Exam Version A 3.0 General Topics in Biotechnology Already Passed

BACE Practice Exam Version A 3.0 General Topics in Biotechnology Already Passed Which of the following is NOT considered a significant advance in PCR methodology? the use of agarose gel electrophoresis to visualize amplified products Match the enzyme to its potential use in the laboratory DNA ligase joining pieces of DNA together Match the enzyme to its potential use in the laboratory Heat-stable DNA polymerase preforming PCR reactions Match the enzyme to its potential use in the laboratory Protease degrading protein Match the enzyme to its potential use in the laboratory Restriction enzymes digesting DNA It is debated that genetically modifies food crops have both beneficial and negative effects on humans and on the environment. Which of the following is a potential negative outcome of growing or consuming genetically modified food crops? -Genetically modified crops may cross-pollinate with non-genetically modified crops -Growing only genetically modified crops my decrease genetic diversity Which of the following is an advantage of treating diabetic patients with genetically engineered human insulin, rather than pig or cow insulin? -There is less chance of an immune response to human insulin -Ethical issues concerning the use of animals are avoided -It is more efficient process to purify insulin from yeast or bacterial cultures than it is from and animal organs "Bioethics" is best described as: the study of decision making as it applies to moral decisions that must be made sue ti advances in biology and technology Why might some people be ethically opposed to using CRISPR/Cas9 to create mutations in animal embryos? Alterations in germline cells will be passed on to future generations Match the person or group with the best example of their responsibility in a biotechnology company. Ensure that all government regulations are followed, working closely with all departments Quality Assurance (QA) Match the person or group with the best example of their responsibility in a biotechnology company. Conducts testing on raw materials, in-process samples, and finished products. Quality Control (QC) Match the person or group with the best example of their responsibility in a biotechnology company. Participates in the production of commercial quantities of a product Manufacturing Match the person or group with the best example of their responsibility in a biotechnology company. Works to identify new or improved products or processes Research and Development Which of the following is the study of the entire set of proteins of a cell or organism? proteomics Which of the following is the study of the full complement of DNA in a cell? genomics Maintaining a safe work environment is critical for the well-being of all employees. Which of the following agencies is responsible for regulations pertaining to worker safety? The Occupational Safety and Health Administration (OSHA) The U.S. agency responsible for regulating biopharmaceuticals for use in humans is: The Food and Drug Administration (FDA) Patenting a new biopharmaceutical will give a company exclusive rights to manufacture the product for a term of ___________ years in the U.S. One reason the U.S. government does this is to incentivize companies to invest in developing new drugs, with the security of knowing they might off-set development costs through revenue gained by selling the drug exclusively. Correct Answer twenty Which department within a biotechnology company is responsible for document control, and for the oversight of regulatory compliance? Quality Assurance __________ ________________ ____________ is a quality system intended to ensure regulatory compliance in pre-clinical laboratory studies. Good Laboratory Practice (GLP) Match the Clinical Trial Phase with its description. Phase 1 Phase with healthy volunteers or people with the disease/condition. The primary focus is on studying safety parameters of the drug. Match the Clinical Trial Phase with its description. Phase 2 Phase with volunteers who have the disease or condition. The primary focus is efficacy and determining side effects. Match the Clinical Trial Phase with its description. Phase 3 Phase with volunteers who have the disease or condition. The primary focus is a broad scale study of the drug's efficacy, and monitoring side effects. The enzyme maltase catalyzes the break down of maltose into glucose. A technician added maltase to a solution of maltose to be incubated at 37°C. Samples were taken from the reaction tube every five minutes over the course of one hour, to measure the glucose concentration. After an hour, the technician noticed the water bath failed to reach 37°C (it only warmed to 25°C). What is the most appropriate course of action for the technician regarding the out of conformance water bath? Report the problem to Quality Assurance (QA) or the individual in charge of repair, and place an "Out of Service" label on the water bath. Which of the following is a controlled document that contains step-by-step instructions on how to perform a routine activity within a company? Standard Operating Procedure Which of the following is a controlled document that contains step-by-step instructions on how to manufacture a product, including spaces for capturing information specific to the task? Batch Record Why must a company manufacturing a controlled product maintain documentation on all processes and checks? -Documentation provides objective evidence that the product was made and tested correctly -Documentation ensures that all personnel followed the proper procedures. -Documentation ensures that all equipment is operating correctly. -Documentation provides a traceable record for the FDA during inspections.