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
About this course:
For a newly discovered product it is important that it reaches the market early to secure market share and that it can be manufactured at affordable cost to en-sure profitability. Development of a new biopharmaceutical drug is difficult because it requires selection of optimal manufacturing technology early in the process and cooperation of disciplines with different talents and mindsets. To ensure smooth transition from product discovery to economical GMP-conforming production, company executives and all specialists from product development, QA/QC, manufacture, facility engineering and regulatory affairs should understand the basics of the production technology and the important process development options and issues.
THIS COURSE WILL IMPROVE YOUR KNOWLEDGE...
of the principles of biopharmaceutical process technology and development.
how to better communicate with other disciplines involved in product development.
how to design economical processes and facilities.
how to meet regulatory expectations.
of regulatory concerns and requirements.
… AND WILL TEACH YOU THE BASICS OF
Recombinant Protein Synthesis in E. coli, Yeast, Animal Cells and Transgenic Animals
Host Cell Selection, Characterization and Optimization
Protein Characterization
Bioreactor Design and Optimization
Scaleup Strategies
GMP-Conforming Equipment Design
Sterilization
Product Recovery and Purification
GMP-Conforming Process and Facility Design
Copyright Center for Continuous Education