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
Request this Course
Level: Intermediate
Lecture HoursLab or Activity HoursTotal
Delivery Options
Face-to-Face
Delivered in a classroom or lab setting.
College Options
Colleges that are able to offer this course.
Related
Course
Customized course for 2019 Grifols Shutdown Training.
Customized course for 2019 Grifols Shutdown Training.
Course
Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing... more
Aseptic gowning is a system of donning apparel to prevent the contamination of aseptic processing... more
eLearning
In this program, we’ll look at the production of Green Fluorescent Protein. GFP is used as a... more
In this program, we’ll look at the production of Green Fluorescent Protein. GFP is used as a... more
Course
Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure... more
Aseptic processing is utilized to prevent contamination and manufacture sterile products to ensure... more
- 1 of 32
- >