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Biomanufacturing Bootcamp
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.
Audience
This course is designed for 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.
Topics Include
- Manufacturing Process Overview
- Current Good Manufacturing Practices (CGMP)
- Upstream Processing: Brief overview of Cell culture
- Upstream Processing: Fermentation and Fermentor Design Requirements
- Fermentation Nutritional Requirements
- Recombinant DNA and Gene Expression Systems
- Key Impurities in Biotechnology Processes
- Downstream Processing: Cell Disruption and Isolation
- Downstream Processing: Protein Purification with Chromatography
- Environmental Monitoring
- Aseptic Processing
- Microbiology Basics
- Cleanroom Design Characteristics and Requirements
- Aseptic Gowning and Cleanroom Behaviors
- Freeze-Drying Fundamentals
- Product Release Testing
- Media Fill Process Simulations
Learning Objectives
- Recognize the basic scientific concepts, equipment, and processes typically utilized in the production, isolation, and purification of a biopharmaceutical product
- Illustrate the phases of the upstream and downstream process
- Identify the components of a small scale fermentor system and operate the system to run a fermentation cycle
- Identify the components of a small scale chromatography system and operate the system using Anion Exchange chromatography
- Describe the role aseptic processing plays in the manufacturing of biopharmaceuticals
- Demonstrate aseptic practices and gowning procedures in a cleanroom
- Explain the principles and theory behind Freeze-drying
- Perform quality control tests for release of samples
Portability
This course must be taught at a BioNetwork location.
Level: Intermediate
Lecture HoursLab HoursTotal
Instructor Pool
Annet Rajan
Janet Rajan
Rebel Umphlett
Tara Hamilton
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