Biotechnology I Course Outline
2010-2011
A. Biotechnology Industry
BTI 01.00 Understand Organizational Structure of the Biotech Industry
1.01 Remember Historical Events and People
A.
1600s Leeuwenhoek
B.
1860 Mendel
C.
1919 Karl Ereky
D.
1943 Penicillin produced on industrial scale
E.
1953 Watson and Crick
F.
1961 – 1966 Genetic Code deciphered
G.
1973 Boyer and Cohen
H.
1978 Genentech produced human insulin in E. coli
I.
1980 Diamond v Chakrabarty Supreme court case
J.
1981 First monoclonal diagnostic kit approved for US
K.
1984 DNA fingerprinting technique developed
L.
1988 Polymerase chain reaction (PCR) method published
M.
1997 First cloned mammal
N.
2003 Human genome project completed
1.02 Understand Types of Companies
A.
Review via web sites and visits to biotechnology
companies the organizational structure of various
biotechnology and pharmaceutical companies
1.
Types of companies: research, pharmaceutical,
manufacturing, multi-disciplined
2.
Identify local biotechnology companies: site visit
1.03 Understand Organizational Structure and Career Options
Research career options and job descriptions for various jobs in the
biotechnology industry including educational requirements and
skills required
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
Explore biotechnology career opportunities
A. Manufacturing
B. Quality Control / Quality Assurance
C. Regulatory
D. Sales and Marketing
E. Research
F. Forensic Pathology
G. Forensic Psychiatry
H. Other areas
Create a personal career development 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
Update College or Job Applications
A. Complete a job application
B. Complete a college application
C. Complete a financial aid or loan application
BTI02.00 Understand Safety Requirements of Working in a Biotech Lab
2.01 Understand Laboratory and Personal Care Safety
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
2.02 Understand OSHA, EPA and aseptic manufacturing requirements
Analyze Material Safety Data Sheets (MSDS)
A.
Proper handling and storage of chemicals through lab set
up
B.
Establish and review all MSDS sheets and their importance
C.
Learn how to request an MSDS from a supplier
D.
Practice reading an MSDS for various types of materials
Outline Federal Agencies that Regulate Safety and Environmental
Protection
A.
Occupational Health and Safety Administration (OSHA)
B.
Environmental Protection Agency (EPA)
C.
Department of Transportation (DOT)
Discuss working in an aseptic environment (lab and manufacturing)
A.
The Mystery Microbe (Biolink Curriculum) or equivalent
B.
Sterile Technique kit (Fisher)
B. Basic Laboratory Skills
BTI03.00Understand Basic Science Behind Biotechnology
3.01 Understand cell structure of Prokaryotes and Eukaryotes
Review differences between eukaryotes and prokaryotes
A.
Prokaryotes
1.
Simple cell
2.
Before nucleus
B.
Eukaryotes
1.
Cells with nucleus
Review of cellular structure and organelle function
A.
Mitochondria
B.
Cytoplasm
C.
Ribosome
D.
Cell Membrane
E.
Nucleus
F.
Golgi apparatus
G.
Vacuoles
H.
Chloroplasts
Explain differences between viruses and Bacteriophages
A.
Viruses
1.
Consist of genetic material enclosed in a capsule
generally made of protein.
2.
Require a host cell to make copies of themselves
3.
When a virus infects a cell it introduces genetic
material into that cell
4.
Extremely specific about the host cell they can
infect
5.
Limited to certain cell types as well as host types
B.
Bacteriophages
1.
Bacterial virus specific to certain bacteria strains
3.02 Understand the role of biological molecules
Discuss the Four Classes of biological molecules
A.
Proteins
B.
Carbohydrates
C.
Nucleic Acids
D.
Lipids
BTI04.00 Apply Procedures for Making Buffers
4.01 Apply math concepts for buffer manufacturing
4.02 Apply proper use of pipettes, balances, vortexers, and pH meters for
buffer manufacture
Learn the art of Pipetting
A.
Explain the various pipets and Pipetting techniques for lab
experiments
1.
Fixed Volume pipets
2.
Disposable pipets
3.
Adjustable volume pipets
4.
Multi channel pipets
B.
Explain how and why pipets are calibrated
1.
Maintain calibration records of pipets
C.
Explain the preventive maintenance for pipets
1.
Maintain preventive maintenance records
Demonstrate Buffer Preparation
A.
Introduce students to laboratory notebooks
1.
Notebook format
2.
Documentation requirements
a.
Pen
b.
Date and Initial
c.
Title of experiment or lab
3.
Grading requirements
B.
Explain Molarity and Dilutions
C.
D.
E.
F.
G.
H.
I.
J.
1.
Practice determining molarity of various solutions
2.
Demonstrate serial dilutions
Explain pH and its importance
1.
Acids
2.
Bases
3.
Neutral
Practice using various methods of measuring Ph
1.
pH meters
2.
pH paper
Explain how and why pH meters are calibrated
1.
Maintain routine calibration sheets in the lab
Explain the preventive maintenance for pH meters
Explain the use of various balances for weighing
1.
Analytical balances
2.
Floor balances
3.
Pan or top load balances
Practice using various pieces of equipment
1.
Explain significant figures
Explain how and why balances are calibrated
1.
Maintain routine calibration sheets in the lab
2.
Verification before use
3.
Use of traceable standards
Explain the preventive maintenance for balances
BT105.00 Apply Skills for Using Laboratory Equipment
5.01 Apply skills for proper use of Spectrophotometers and
chromatography techniques
Understand how to use a Spectrophotometer
A.
Explain the use of the spectrophotometer
1.
Visible
2.
Ultra Violet
B.
Practice using various pieces of equipment
1.
Protein standard curve assays
2.
Colorimetric assays
C.
Explain how and why spectrophotometers are calibrated
1.
Maintain routine calibration sheets in the lab
D.
Explain the preventive maintenance for spectrophotometer
Demonstrate extractive separation and chromatography
A.
Isolation of caffeine from tea (extractive separation)
B.
Column chromatographic separation of plant pigments
C.
Thin layer chromatographic analysis of analgesic drugs
Explore physical properties and molecular polarity
A.
The causes of molecular polarity
B.
Attractions between molecules
C.
Solubility properties of substances
D.
The melting process
E.
The boiling process
5.02 Apply skills for proper use of Microscopes and Centrifuges
Demonstrate proper use of the Microscopes
A.
Explain the use of the microscope
1.
Objectives
2.
Stage
3.
Condenser
4.
Ocular (eye piece)
5.
Course adjustment
6.
Fine adjustment
B.
Practice using various pieces of equipment
1.
Prepared Gram stains
2.
Pond water
3.
Prepared blood smears
C.
Explain the preventive maintenance for microscope
Explore Centrifugation
A.
Explain the use of various centrifuges
1.
Micro-centrifuge
2.
Bench top centrifuge
3.
2-8C centrifuge
B.
Practice using various pieces of equipment
1.
Explain balancing a centrifuge
2.
Explain rpm and its importance
C.
Explain how and why centrifuges are calibrated
1.
Maintain routine calibration sheets in the lab
D.
Explain the preventive maintenance for centrifuges
C. Regulation of the Biotechnology Industry
BTI06.00 Understand FDA Role in Biotech Industry
6.01 Understand the organizational structure and roles of the FDA
Explore the Role of the FDA
A.
Food Drug and Cosmetic Act
B.
Food and Drug Administration
1.
Identify various products regulated by the FDA
C.
Good Manufacturing Practices
1.
Review various warning letters
2.
Review 483s from inspections
Explore the Organization of the FDA
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)
6.02 Understand the audit, clinical trial, and batch record requirements
Auditing to the Standards
A.
Audit Elements
1.
Training
2.
Document Control
3.
Material Storage and Handling
Design a clinical trial
A.
Review the various phases of a clinical trial
B.
Incorporate the use of blinded samples
C.
Define roles
1. Primary investigator
2. Data reviewers
D.
Define planned statistical analysis
Select clinical trial site and participants
Define required approvals: Internal Review Board
Execute and monitor clinical trial
G.
Gather data
H.
Monitor participants
Summarize Data Analysis
I.
Analyze data using statistical processes
J.
Comment on outliers, mean, standard deviation
Explain the labeling requirements for product
A. Product Labels
B. Package inserts
Explain the approval requirements for marketing literature
A. Marketing materials
E.
F.
BTI07.00 Understand Quality Systems Regulations in the Biotech Industry
7.01 Understand current Good Manufacturing Practices and basics of
standard operating procedures
Explain Good Manufacturing Practices and Quality System Regulations
A.
Define Good Manufacturing Practices
B.
Define Quality System Regulations
1.
Review of the QSR standards
2.
Differences between 9000, 9001, 9002 certifications
3.
Pros and Cons of certifications
7.02 Understand the basics of Good Laboratory Practices
Good Laboratory Practices
A.
Why they were developed
B.
Who must follow them
Explain and demonstrate Good Lab Practices (GLP)
Understand and write Standard Operating Procedures
A.
How to read, write and follow an SOP
B.
Understanding what a batch record is
C.
Completing a batch record according to GMP
D.
Storage and handling of documents
D. Forensics
BTI08.00 Understand Crime Scene Processing
8.01 Understand the field of forensic science and career options
A.
Forensic scientist
B.
Forensic engineer
C.
Forensic pathologist
D.
Forensic technician
E.
Forensic anthropologist
F.
Toxicologist
8.02 Understand the basics of evidence collection and storage
A.
Arriving at the scene
B.
Collecting evidence
C.
Packaging of evidence
D.
Chain of Custody
E.
Submission of Evidence
BTI09.00 Understand Crime Scene Analysis
9.01 Understand Fingerprinting techniques
A.
Types of Fingerprints
B.
Fingerprinting process
C.
Latent Fingerprints
9.02 Understand Blood analysis and splatter techniques
A. Hematology overview
B. Blood Splatter Analysis
1. Effects of angle and height of samples
C. Blood Typing
a. ABO blood types
b. Rh factor