Final Review for Biotech I

Unit A The Biotech Industry (20%) Powerpoint summary

I. Describe the contributions these people/events made to the field of science/biotechnology.

A. Leeuwenhoek

B. Mendel

C. Karl Ereky

D. Penicillin

E. Watson and Crick

G. Boyer and Cohen

H. Genentech produced human insulin in E. coli

I. Diamond v Chakrabarty Supreme court case

K. Alec Jeffreys

L. Kary Mullis

M. Dolly

N. Human genome project

2. Describe what these type of companies do

A. research

B. pharmaceutical

C. manufacturing

D. multi-disciplined

3. List the job description and educational requirements for the careers below.

A. Regulatory Affairs

B. Research Scientist

C. Manufacturing technician

D. Bio-processing engineer

E. Quality Assurance

F. Quality Control

G. Statistician

H. Clinical Affairs

I. Lawyer: patent, general counsel, compliance officer

J. Metrology

K.. Materials department and inventory control

L. Manufacturing

M. Quality Control / Quality Assurance

N. Regulatory

O. Sales and Marketing

P. Research

Q. Forensic Pathology

R. Forensic Psychiatry

4. Include the following information in your career plan

A. Career goal

B. Educational requirements

C. Work experience / Volunteer opportunities

D. Financial plan

1. Cost of tuition

2. Scholarship opportunities

3. Personal budget plan

Unit B Lab Skills (50%) Powerpoint Summary

Unit B1 Basic Biology Behind Biotechnology

5. Provide information for the following safety procedures

A. Review proper hand washing technique

B. Review proper gowning technique

C. Review proper use of safety glasses

D. Lab Surface cleaning procedure

E. Fire safety

F. Proper handling of spills

G. Glassware cleaning procedure

H. Waste disposal procedure

I. Sterile Technique

6. Describe an MSDS sheet and tell how and why it is used.

7. What is the function of the following agencies regarding safety

A. OSHA

B. EPA

C. DOT

8. Give the differences between prokaryotes and eudaryotes

9. Give the function of each of the following

A. Mitochondria

B. Cytoplasm

C. Ribosome

D. Cell Membrane

E. Nucleus

F. Golgi apparatus

G. Vacuoles

H. Chloroplasts

10. Explain the differences between cells and viruses. What is a bacteriophage?

11. Describe the four classes of biological molecules.

A. Proteins

B. Carbohydrates

C. Nucleic Acids

D. Lipids

Unit B2 Metrology

12. Explain the various pipets and Pipetting techniques for lab experiments

A. Fixed Volume pipets

B. Disposable pipets

C. Adjustable volume pipets

D. Multi channel pipets

13. Explain how and why pipets are calibrated

14. Explain the proper way to keep a lab notebook

15. Explain how the different types of lab balances are used and calibrated.

16. What is the difference between span calibration and linear calibration of balances?

Unit B3 Solution Prep

17. How much NaOH (in grams) would you weigh out to make the following solutions?

10 ml of 100 mg/ml,

50 ml of 5 %

100 ml of 0.1 M

18. Explain how you would label the reagent bottle containing the solutions

19. How could you dilute a 10M HCl solution to make 100 ml of 1 M HCl?

20. Show how you serial dilute 10M HCl to get a 0.1M HCl solution.

21. Compare and contrast acids and bases.

22. What is pH and list three ways to measure it.

Unit B4 Equipment & Techniques

24. Explain how spectrophotometers work.

25. What is an absorption spectrum?

26. What is a standard curve?

27. What are the components of chromatography?

28. What are the different types of chromatography?

29. What other physical properties of matter can you use to separate molecules?

30. What are centrifuges and how do they work?

31. What is one of the main rules to follow when using a centrifuge?

32. What does “rpm” and “x g” mean when using a centrifuge?

33. What are the parts of a microscope?

34. Write down the steps to follow to use a microscope?

35. What is gel electrophoresis used for and how does it work?

36. What are the steps necessary to aseptically culture bacteria?

UNIT C Regulation of the Biotech Industry (15%) Powerpoint Summary

37. What is the role of the FDA?

38. When was the Food Drug and Cosmetic Act enacted?

39. List some various products regulated by the FDA

40. What can the FDA do whenever there is a problem with a regulated product?

41. What is a 483 Warning Letter? What is in it and who does it go to?

42. What are the follow FDA centers responsible for? Give some examples.

a. Center for Drug Evaluation and Research (CDER)

b. Center for Biologics Evaluation and Research (CBER)

c. Center of Devices and Radiological Health (CDHR)

d. Center for Food Safety and Applied Nutrition (CFSAN)

43. Explain the process of taking a drug from the lab bench to market. What steps must take place.

44. What are Good Laboratory Practices? Why they were developed? Who must follow them?

45. Give some examples of GLP.

46. What are Standard Operating Practices?

47. What are clinical trials?

48. What are the four phases of a clinical trial?

49. What is the difference between a single-blind and a double-blind study?

50. Who are some people involved in clinical studies?

51. What is statistical probability?

52. What is an outlier?

53. What is an IRB and what do they do?

54. What is cGMP?

55. What departments of a manufacturing company are under cGMP regulations? Give some examples?

56. What is the difference between cGMP, QSR and ISO?

57. What is a batch record and why is it used?

58. What does a QA do?

59. What are some labeling requirements for a product?

60. Why does FDA regulated marketing literature?

61. What is an audit?

62. What can be audited in a manufacturing company?

63. Who does the audit?

Unit D Forensic Science (15%) Powerpoint Summary

64.. Write a job description for each of the following forensic careers

a. Forensic scientist

b. Forensic engineer

c. Forensic pathologist

d. Forensic technician

e. Forensic anthropologist

f. Toxicologist

65. What are the five means of death determined by a forensic pathologist?

66. Describe four different ways that the post-mortem interval (time of death) can be determined.

67. Describe what a crime scene technician would do for each of the following

a. Arriving at the scene

b. Collecting evidence

c. Packaging of evidence

d. Chain of Custody

e. Submission of Evidence

68. What are three types of fingerprints left at a crime scene?

69. What causes a print to be left by a finger?

70. What are the three main types of latent prints?

71. What is hematology and serology?

72 Explain what you know about blood typing.

73. What all can be learned from blood spatter evidence?