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