This course will focus on the details of the typical processing procedures utilized to produce a biopharmaceutical product. An understanding of the science and the equipment commonly used in each process step will be presented along with a review of the basic biochemistry involved in biotechnology and current pharmaceutical applications. Hands-on laboratory exercises will provide experience in the fermentation, product isolation, and purification of a protein.
This course is designed for entry level process technicians, incumbent workers as well as experienced professionals in Manufacturing, Quality Management or Senior Management positions in the biopharmaceutical industry.
This 4-day, 8-hour course covers the following topics:
- Science of Biotechnology
- Basic cGMP principles
- Recombinant DNA techniques
- Upstream Fermentation Processes
- Brief history of fermentation, metabolism and growth
- Fermentation principles,equipment, controls and monitoring
- Bioreactor component identification
- Gene Expression Systems
- Chemistry of Proteins
- Downstream Processes
- Principles of Chromatography (Size exclusion, affinity, ionic exchange, hydrophobic interaction)
- Supernatant for chromatography preparation
- Chromatography system component identification
- Ultrafiltration, Evaporation, Precipitation, Liquid extraction and Crystallization
- Cell Disruption
- Explain the fundamental science behind biotechnology and its application in the pharmaceutical industry.
- Discuss basic science, equipment, and processing steps typically utilized in the production, isolation and purification of a biopharmaceutical product.
- Demonstrate proficiency with common instrumentation used in the production, isolation and purification of a biopharmaceutical product.
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