Downstream Processing

Continuing discoveries in molecular biology, genetics, and process science provide the foundation for new and improved processes and products in today's biochemical process industry. The production of therapeutic proteins and other biologics, made possible by discoveries in biotechnology, generated sales exceeding $300 billion in 2016. 

Biotechnology is a cornerstone for improvement and expansion of the biochemical process industry for production of enzymes, diagnostics, chemicals, pharmaceuticals, and foods. Continued introduction of new technology necessitates innovation in process development scale-up and design as manufacturing lies on the critical path between science and the consumer. 

An integral and cost-intensive part of these processes is associated with downstream processing for product isolation and purification. This course aims to help participants design new, as well as to improve existing, biological manufacturing for downstream processes.

Certificate of Completion from MIT Professional Education

• Understanding the fundamentals of downstream processing for biochemical product recovery.
• Assessing the impact of change on overall process performance.
• Examining traditional unit operations, as well as new concepts and emerging technologies that are likely to benefit biochemical product recovery in the future.
• Understanding analytical and process validation issues that are critical to successful manufacturing.
• Strategies for biochemical process analysis and synthesis.
• Design and operation of unit processes with centrifugation, chromatography, filtration, and membrane processes
• Introduction to continuous processing, process economics, process synthesis and simulation, and regulatory issues and validation.

Program Outline

The topics to be covered include:

• Introduction to biochemical manufacturing strategy
• Cell separation and clarification
• Quality assurance and control
• Chromatography fundamentals (2 sessions)
• Chromatography design and operation 
• Filtration fundamentals
• Process validation and Quality by Design
• Bioprocess design and economic analysis
• Aseptic design and viral clearance

The program is under the direction of Professor Charles L. Cooney. Lectures will be presented by:

• Dr. Stuart E. Builder, Strategic Biodevelopment, Belmont, CA
• Dr. Charles L. Cooney, Professor of Chemical and Biochemical Engineering, emeritus at MIT
• Dr. Steven Cramer, William Weightman Walker Professor of Polymer Engineering at Rensselaer Polytechnic Institute, Troy, New York
• Ranga Godavarti, Sr. Director, Purification Process Development, Bioprocess R&D Pfizer, Andover, MA
• Dr. Jean-Francois Hamel, Lecturer & Research Engineer, MIT
• Dr. Robert Baffi, Executive Vice President of Technical Operations, Bio Marin Pharmaceutical Inc, Novato, CA
• Dr. James Leung, Research Scientist, MIT Center for Biomedical Innovation
• Dr. J. Christopher Love, Associate Professor of Chemical Engineering, Koch Institute for Integrative Cancer Research, MIT

Links & Resources

The course covers fundamental principles of downstream processing with practical examples and case studies to illustrate the problems and solutions faced by the practitioner. It is intended to provide both insight into and an overview of downstream processing for individuals actively engaged in process research and development, as well as those who manage and innovate in the biochemical process industry. Scientists and engineers engaged in fermentation and cell culture development attend the course to better understand the context of the whole process. Attendees include:

• Engineers and scientists interested in design, economics, validation optimization and scale-up of biochemical product recovery;
• Protein biochemists and chemists involved in design and optimization of biologics recovery processes;
• Managers responsible for biochemical process development;
• Entrepreneurs, attorneys, and business leaders seeking an overview and insight into biochemical manufacturing.