Biomanufacturing Bootcamp

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

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Portability

This course must be taught at a BioNetwork location.

Level: Intermediate

Lecture HoursLab or Activity HoursTotal

Instructor Pool

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