BACE written/practical exam - biotech 20

what is not considered a significant advance in PCR methodology - the use of agarose gel electrophoresis to visualize amplified products describe DNA ligase - joining pieces of DNA together describe heat stable DNA polymerase - performing PCR reactions describe protease - degrading protein describe restriction enzymes - digesting DNA what is a negative outcome of growing or consuming genetically modified food crops? - decrease genetic diversity bioethics is best described as - the study of decision making as it applies to moral decisions that must be made due to advances in biology and technology describe quality control - ensure that all government regulations are followed, working closely with all departments describe quality assurance - conducts testing on raw materials, in-process samples, and finished products describe manufacturing - participates in the production of commercial quantities of a product describe research and development - works to identify new or improved products or processes what is the study of the entire set of proteins of a cell or organism? - proteomics what is the study of the full complement of DNA in a cell? - genomics what agency is responsible for regulations pertaining to worker safety? - the occupational safety and health administration the U.S. agency responsible for regulating biopharmaceuticals for use in humans is: - the food and drug administration in the U.S., cGMPs are regulated by which agency? - the food and drug administration which department within a biotechnology company is responsible for document control, and for the oversight of regulatory compliance? - quality assurance what is GLP? (good laboratory practice) - quality system intended to ensure regulatory compliance in pre-clinical laboratory studies match the clinical trial phase with it's description: - phase with healthy vounteers or people with the disease and condition, primary focus is on studying safety parameters of the drug - phase with volunteers who have the disease, primary focus is efficacy and determining side effects - phase with volunteers who have the disease, primary focus is broad case study of the drug's efficacy, and monitoring side effects - phase 1, phase 2, phase 3 what is a controlled document that contains step-by-step instructions on how to perform a routine activity within a company? - SOP what 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