Biotechnology

Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.


Course Details & Registration Information

Course
Biomanufacturing Boot Camp
Name
SEF-79914
Available Classes
Not currently offered.
Description Course Outline Requirements Intended Audience More Details
Intended Audience
Students, entry-level bioprocess operators/technicians, and incumbent workers, as well as other professionals in the biotechnology industry seeking training and hands-on experience in upstream and downstream processes of the manufacturing of a pharmaceutical product.
Description
This course allows participants to experience biopharmaceutical manufacturing through lectures and hands-on production of green fluorescent protein (GFP) within a current good manufacturing practices (cGMP) environment. The course details the steps and equipment utilized in the upstream and downstream processes of the manufacturing of a pharmaceutical product. The Capstone Center is a fully functional facility containing state-of-the-art equipment, analytical technology and a clean room production environment (certified cleanroom suite) that provides a realistic experience for participants.
Course Objectives
  1. Recognize the basic scientific concepts, equipment, and processes typically utilized in the production, isolation, and purification of a biopharmaceutical product.
  2. Illustrate the phases of the upstream and downstream process.
  3. Identify the components of a small scale fermentor system and operate the system to run a fermentation cycle.
  4. Identify the components of a small scale chromatography system and operate the system using Anion Exchange chromatography.
  5. Describe the role aseptic processing plays in the manufacturing of biopharmaceuticals.
  6. Demonstrate aseptic practices and gowning procedures in a cleanroom.
  7. Explain the principles and theory behind Freeze-drying.
  8. Perform quality control tests for the release of samples.
Outline of Instruction
  1. Day 1 Lectures:
    - Introductions/logistics/learning objectives
    - Overview of pharmaceutical industry culture
    - FDA mission and drug approval process
    - Summary of CGMP
    - Active pharmaceutical ingredient /guidance/regulation
    - Definition of quality and quality units
    - Documentation - SOP/MMR/BPR
    - Upstream process/fermentation
    - Fermentor design requirements and operating modes
    - Aerobic fermentation nutritional requirements
    - Downstream processing
    - Key impurities in biotechnology process
    - Cell disruption
    - Sedimentation
    - Filtration
  2. Day 1 Labs:
    - Fermenter inoculation
    - Shaker/bioreactor parts identification
    - Basic protein chemistry
    - Recombinant technology and insulin
    - The arabinose operon
    - View arabinose inducer plates
    - Sonication demo
  3. Day 2 Lectures:
    - Centrifugation
    - Ultrafiltration
    - Purification operations/chromatography
  4. Day 2 Labs:
    - Prepare supernatant for chromatography
    - AKTA Prime Chroma system identification
    - AEX chromatography run
  5. Day 3 Lectures:
    - Aseptic processing rational, aseptic gowning and cleanroom behaviors
    - Brief microbiology review
    - Product release testing
  6. Day 3 Labs:
    - Lyophilization
    - Sterile gowning
    - Filtration (GFP)
    - Filter integrity test
    - Steri-test
    - Liquid particulate testing
  7. Day 4 Lectures:
    - Course review
    - Unload freeze-dryer
    - Jeopardy
  8. Day 4 Labs:
    - Cleanroom tour
    - GFP filling demo and filling
    - Labeling
    - QC tests
    - Inspect filtration bottles
    - Inspect steri-test bottles
    - Read microbial plates
Contact Hours
32
CEU's
3.2
Industry Standard, State, or National Certification
No
CE to CU Articulation
No
Prerequisites
Text and Supplies Needed
Materials will be provided in class
Clinical Site/Special Facilities
Requirements for Successful Completion of this Course
  1. Attendance 95% or above
  2. Participation
Accreditation/Special Approval Requirements
Intended Audience
Students, entry-level bioprocess operators/technicians, and incumbent workers, as well as other professionals in the biotechnology industry seeking training and hands-on experience in upstream and downstream processes of the manufacturing of a pharmaceutical product.
Specific Industry or Business Support Needs
Industry or Job Titles Related to training Outcomes for Employment
  • Bioprocess technicians
  • Bioprocess operators
Related Courses
  • Aseptic Processing Level I - SEF-79964
  • Aseptic Processing Level II - SEF-79974
  • Cleanroom Gowning Certification - SEF-79244
  • Upstream Processes: Microbial Fermentation - SEF-412CL
  • Freeze-Drying Fundamentals - SEF-79874
  • Cell Culture Processes - SEF-79634
  • Chromatography in Theory and Practice - SEF-79614
Course Contact Information
Amber Baker