New Biotechnology I Course Outline



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

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

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

01. Apply math concepts for buffer manufacturing

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

1. Practice determining molarity of various solutions

2. Demonstrate serial dilutions

C. Explain pH and its importance

1. Acids

2. Bases

3. Neutral

D. Practice using various methods of measuring Ph

1. pH meters

2. pH paper

E. Explain how and why pH meters are calibrated

1. Maintain routine calibration sheets in the lab

F. Explain the preventive maintenance for pH meters

G. Explain the use of various balances for weighing

1. Analytical balances

2. Floor balances

3. Pan or top load balances

H. Practice using various pieces of equipment

1. Explain significant figures

I. Explain how and why balances are calibrated

1. Maintain routine calibration sheets in the lab

2. Verification before use

3. Use of traceable standards

J. Explain the preventive maintenance for balances

BT105.00 Apply Skills for Using Laboratory Equipment

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

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

E. Select clinical trial site and participants

F. 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

BTI07.00 Understand Quality Systems Regulations in the Biotech Industry

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

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