Upstream Bioprocessing Calculations and Strategies

ISPE CEUs*: 1.3
Type: Classroom Training Course

Description

This advanced-level course builds on the principles of the Biopharmaceutical Process Development course, and covers basic principles related to the upstream processing of the bioproduct. The goal is to promote understanding of the development and use of working equations and theory pertaining to the growth of cells and production of bioproducts in fermentors and bioreactors. This course addresses the different equipment types associated with the various upstream unit operations of a typical biotechnology process. Course topics include:

• Fundamentals of biochemistry, cell biology, microbiology and molecular biology related to bioprocess operations
• Enzyme kinetics and assays/probes 
• Cell growth and product formation kinetics 
• Heat sterilization 
• Oxygen transfer and mixing 
• Scale-up 
• Alternate modes of operation (fed-batch, perfusion) 
• Alternate bioreactor configurations 
• Shear damage in bioreactors 
• Carbon dioxide exchange in bioreactors 
• Cell disruption

The course will also address the differences between fermentors and bioreactors. Participants will receive illustrations of biological systems, and a summary of terms and working equations useful in process development.

In addition, participants will be led through concise derivations of the working equations and example problems that illustrate use of the equations. Specific discussions on cell culture, including selection and amplification of stable cell lines will be explored. Options for optimizing carbon dioxide exchange and minimizing shear in bioreactors will be evaluated.

Take Back Your Job

• Recognize different types of biomolecules and cells
• Cite fundamental techniques of genetic engineering and examples of their use
• Estimate rates of enzyme-catalyzed reactions with and without mass transfer limitations
• Estimate cell growth and product formation rates in batch and continuous culture
• Estimate the probability of reactor contamination
• Estimate the oxygen transfer coefficient for a variety of reactor configurations 
• Scale up a fermentor/bioreactor
• Estimate cell growth and product formation rates in fed-batch and perfusion cultures
• Design bioreactors to minimize shear damage and optimize carbon dioxide exchange
• Select an appropriate cell disruption method

Attendance Suggested For

• Individuals within the sciences or engineering fields who have an interest in using theoretical and practical equations to model and/or improve the performance of fermentors and/or bioreactors.
• This training course is of particular interest to existing and future members of the ISPE Biotechnology Community of Practice (COP).

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.