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BIT 271 Principles of Biotechnology

In this course students discuss topics in the major areas of biotechnology. They include the role of biotechnology in the development of food, fuels, pharmaceuticals and other biologics. This course investigates the role of quality systems and regulatory affairs in the production of biotech products including upstream and downstream processing, good laboratory practices (GLPs), Good Manufacturing Practices (GMPs), documentation, standard operating procedures (SOPs), and federal regulations. Additional topics include intellectual property, aseptic techniques, genetic engineering, fermentation, tissue culture, product development cycles, and the life cycle of biotech businesses. Laboratory work is an integral part of this course.

Credits

4

Prerequisite

Prerequisite: BIO 250 and CHM 150

See Course Syllabus

Course Number and Title:

BIT 271 Principles of Biotechnology

Campus Location

  • Stanton

Prerequisites

Prerequisite: BIO 250 and CHM 150

Course Credits and Hours

4 credit(s)

3 lecture hours/week

3 lab hours/week

Course Description

In this course students discuss topics in the major areas of biotechnology. They include the role of biotechnology in the development of food, fuels, pharmaceuticals and other biologics. This course investigates the role of quality systems and regulatory affairs in the production of biotech products including upstream and downstream processing, good laboratory practices (GLPs), Good Manufacturing Practices (GMPs), documentation, standard operating procedures (SOPs), and federal regulations. Additional topics include intellectual property, aseptic techniques, genetic engineering, fermentation, tissue culture, product development cycles, and the life cycle of biotech businesses. Laboratory work is an integral part of this course.

Additional Materials

Laboratory Notebook
Laboratory coat

Required Text(s)

Obtain current textbook information by viewing the campus bookstore - https://www.dtcc.edu/bookstores online or visit a campus bookstore. Check your course schedule for the course number and section.

Disclaimer

None

Core Course Performance Objectives (CCPOs)

  1. Integrate knowledge of biology with the field of biotechnology.  (CCC 2, 4, PGC 1, 2, 4, 5, 9)
  2. Summarize the use of DNA technology and genetic engineering in biotechnology including relevant regulations. (CCC 2, 6, PGC 1, 6)
  3. Access and use information technology related to the field of biotechnology. (CCC 2, 5, 6, PGC 1)
  4. Apply biotechnology principles of quality management systems to the creation of a biotech product.
  5. Apply the principles of biotechnology to laboratory work. (CCC 1, 2, 3, 4, 6, PGC 1, 2, 3, 4, 5, 6, 7, 8, 9).

See Core Curriculum Competencies and Program Graduate Competencies at the end of the syllabus. CCPOs are linked to every competency they develop.

Measurable Performance Objectives (MPOs)

Upon completion of this course, the student will:

  1. Integrate knowledge of biology with the field of biotechnology.
    1. Define biotechnology.
    2. List historical examples of classical biotechnology, e.g. fermentation.
    3. Describe and give examples of different biotechnology applications in agriculture, animal husbandry, forensics, bioremediation, biofuels, and medicine.
    4. Discuss the biotechnology workforce.
    5. Discuss current biotechnology regulations and guidelines, including ISO 9001:2015, ISO 17025:2017 and ISO 15195:2018.
    6. Define GMP and GLP.
    7. Explain role of U.S Food & Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Environmental Protection Agency (EPA) in regulating the biotech industry.
    8. Describe the process of drug discovery and development.
    9. Explain the biotechnology business life cycle from start up to merger/sale.
  2. Summarize the use of deoxyribonucleic acid (DNA) technology and genetic engineering in biotechnology including relevant regulations.
    1. Define recombinant DNA, host, vector, and plasmid.
    2. Compare common bacterial and eukaryotic host organisms.
    3. Diagram the steps involved in the production and selection of a recombinant organism and/or product.
    4. Describe strategies employed to enhance product synthesis.
    5. List several examples of genetically engineered pharmaceutical products and their uses.
    6. Discuss the uses of DNA technology in agriculture.
    7. Diagram the production and selection of a transgenic plants.
    8. Describe methods used to produce transgenic animals and their purposes.
    9. Discuss the use of DNA technology in environmental and food safety monitoring.
    10. Discuss the use of biotechnology in developing biofuels.
    11. List regulatory agencies and laws governing DNA technology.
  3. Access and use information technology related to the field of biotechnology.
    1. Investigate a selected biotechnology topic and present in a report.
    2. Analyze DNA sequences using sequencing programs available using internet sources, including NCBI.
    3. Analyze protein structures using internet sources.
    4. Investigate intellectual property rights using internet resources.
    5. Find and correctly cite published resources used in laboratory procedures.
  4. Apply biotechnology principles of quality management systems to the creation of a biotech product.
    1. Discuss the components of a quality system in biomanufacturing.
    2. Discuss International Organization for Standardization (ISO) guidelines and their relevance to biomanufacturing.
    3. Discuss regulatory affairs as it relates to biomanufacturing.
    4. Diagram a product life cycle including research and development, scale up, production, quality assurance/quality control (QA/QC), raw material, and final product sample testing.
    5. Apply the concepts of product variability, specifications, in-process testing, critical points, validation, nonconformance and deviations to product development.
    6. Describe the role of intellectual property in product development and documentation including the concepts of conception, reduction to practice, corroboration, diligence, trade secrets, non-disclosure agreements, patents and infringement.
    7. Apply the role of GMPs and GLPs in the creation of a biotech product.
    8. Discuss the functions of documentation relevant to biotech products including: directive documents (standard operating procedures), data collection documents, particularly batch records, and commitment documents.
  5. Apply the principles of biotechnology to laboratory work.
    1. Use personal protective equipment (PPE), and demonstrate safe handling of chemicals in the laboratory.
    2. Document laboratory work, and maintain a laboratory notebook.
    3. Write and follow a standard operating procedure (SOP).
    4. Prepare common laboratory solutions.
    5. Demonstrate aseptic techniques including correct use of a biological safety cabinet.
    6. Use biotechnology techniques to create a biotechnology product with a corresponding batch record.
    7. Apply problem solving skills to find the root cause(s) of an out of specification (OOS) result, and create an appropriate corrective action and preventative action (CAPA).
    8. Apply biotechnology tools including laboratory equipment, instrumentation, and bioinformatics to genetic engineering, fermentation, and tissue culture.
    9. Demonstrate effective collaboration while working as part of a team.

Evaluation Criteria/Policies

The grade will be determined using the Delaware Tech grading system:

90-100 = A
80-89 = B
70-79 = C
0-69 = F
Students should refer to the Catalog/Student Handbook for information on the Academic Standing Policy, the Academic Integrity Policy, Student Rights and Responsibilities, and other policies relevant to their academic progress.

Program Graduate Competencies (PGCs are the competencies every graduate will develop specific to his or her major)

  1. Apply knowledge of biology and chemistry to solve problems in biotechnology.
  2. Integrate biological knowledge with the regulatory, ethical and business perspectives relevant to the biotechnology industry.
  3. Apply quantitative and computational skills and tools to analyze problems in biology and chemistry.
  4. Demonstrate good laboratory practices that are required by a person working as a biotechnology technician including laboratory safety and documentation.
  5. Demonstrate laboratory skills relevant to biotechnology including recombinant DNA techniques, PCR, DNA sequence analysis, and current analytical chemistry techniques.
  6. Work independently and collaboratively to create scientific oral presentations and written documents that are standard to the discipline.

Core Curriculum Competencies (CCCs are the competencies every graduate will develop)

  1. Apply clear and effective communication skills.
  2. Use critical thinking to solve problems.
  3. Collaborate to achieve a common goal.
  4. Demonstrate professional and ethical conduct.
  5. Use information literacy for effective vocational and/or academic research.
  6. Apply quantitative reasoning and/or scientific inquiry to solve practical problems.

Students in Need of Accommodations Due to a Disability

We value all individuals and provide an inclusive environment that fosters equity and student success. The College is committed to providing reasonable accommodations for students with disabilities. Students are encouraged to schedule an appointment with the campus Disabilities Support Counselor to request an accommodation needed due to a disability. The College's policy on accommodations for persons with disabilities can be found in the College's Guide to Requesting Academic Accommodations and/or Auxiliary Aids Students may also access the Guide and contact information for Disabilities Support Counselors through the Student Resources web page under Disabilities Support Services, or visit the campus Advising Center.

Minimum Technology Requirements

Minimum technology requirements for all distance education type courses.

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