1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
Course Content:
Basics of Molecular and Cell Biology
Properties and Characterization of Proteins
Protein Synthesis in Procaryotes and Eucaryotes
Expression of Foreign Proteins in E. coli, Yeast, Animal Cells and Transgenic Animals
Physiological Requirements of Bacteria, Yeast and Animal Cells
Selection of Appropriate Expression System
Advantages and Disadvantages of the Major Host Systems
Optimization Strategies for Cell Specific Productivity
Nutrient Development Strategies
Regulatory Concerns
Cell Bank Establishment, Characterization and Qualification
Scaleup to Production Size
Estimation of Required Production Scale
Fermenter and Bioreactor Designs
Batch vs. Continuous Production
Inoculum and Nutrient Preparation
Optimization of Reactor Operation
Reactor Scaleup
Sanitization, Sterilization and Depyrogenation
GMP-Conforming Equipment Design
Clean-in-Place
SteaminPlace
Autoclaving, Dry-Heat and Chemical Sterilization
Sterile Filtration
Integrity Testing of Equipment and Filters
Product Recovery and Purification
Product Harvest
Centrifugation
Tangential-Flow Micro- and Ultrafiltration
Protein Purification Methods
Removal of DNA, Viruses and Pyrogens
Scaleup and Validation of Purification Methods
Process Design
Logical Sequencing of Unit-Processes
Development of Process Flow and Piping and Instrumentation Diagrams (P&ID's)
Facility Design
Requirements of GMP-Conforming Production Facilities
Pilot Plant vs. Production Facility
Multiproduct vs. Dedicated Manufacturing Facility
Utility Requirements
Regulatory Requirements
Integration of Regulatory Requirements with Process Development
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