Date: TBD 2016 | Tuition: TBD | Continuing Education Units (CEUs): TBD
*This course has limited enrollment. Apply early to guarantee your spot.
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Learning Objectives |
Who Should Attend |
Course Format |
Outline of the Course |
Course Schedule |
Participants' Comments |
About the Course Director |
Links & Resources
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, which is made possible by discoveries in biotechnology, generated sales exceeding $150 billion in 2014. In addition, biotechnology has led to marked improvement and expansion in the traditional 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 a consequence, there is the need to design new, as well as to improve existing, processes. An integral and cost intensive part of these processes is associated with downstream processing for product isolation and purification.
Fundamentals: Core concepts, understandings, and tools (40%)
Latest Developments: Recent advances and future trends (20%)
Industry Applications: Linking theory and real-world (25%)
Team work on a case study (15%)
Lecture: Delivery of material in a lecture format (75%)
Discussion or Groupwork: Participatory learning (25%)
Introductory: Appropriate for a general audience (50%)
Specialized: Assumes experience in practice area or field (25%)
Advanced: In-depth explorations at the graduate level (25%)
- Introduction to the fundamentals of downstream processing for biochemical product recovery.
- Assess the impact of change in unit's operations and the impact on the process.
- Examine traditional unit operations, as well as new concepts and emerging technology that is likely to benefit biochemical product recovery in the future.
- Analyze both analytical and process validation issues that are critical to successful manufacturing, focusing on large-scale, high-purity protein production.
- Examine strategies for biochemical process synthesis.
- Address centrifugation, chromatography, filtration, membrane processes, an introduction to continuous processing, process economics, process synthesis and simulation, and regulatory issues and validation.
Who Should Attend
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. Increasingly, 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 of recovery processes;
- Managers responsible for biochemical process development;
- Entrepreneurs, attorneys, and business leaders seeking an overview and insight into biochemical manufacturing.
The course faculty have worked together for over 25 years teaching this course. The format includes a series of lectures on individual topics and discussion of case studies. All students participate in a group design exercise to bring together systems thinking about process synthesis and design.
The lectures begin promptly at 9:00 am Monday. Lectures end at 5:30 pm each day except Friday when they finish by 12:00 noon. In addition to classroom lectures, attendees will participate on team projects with break-out teams from 1:00 - 2:00 pm Monday through Thursday. Team project presentations are made on Friday from 9:00 am to noon.
Tuition includes both electronic (USB flash drive) and hard copy versions of the lecture notes. These are made available to participants during the week of class.
Outline of the Course
The course begins with an introduction to the recovery problems created by fermentation, cell culture, and enzyme technology. Subsequent topics include:
- Process design: The first steps
- Biochemical Processing: Overview
- Virus clearance in downstream process of cell culture-based therapeutics
- Quality: Beyond pass or fail
- Filtration fundamentals
- Extraction case study
- MAB case study
- Process design & economics
- Process validation
- Quality by Design
- Filtration application
- Team design project
There are discussions of case studies to illustrate innovations in downstream processing. The class is divided into teams early in the week to work as a team on a project that illustrates the concepts from the lectures.
Course schedule, registration times, special events
View 2015 Course Schedule (pdf, subject to change)
Registration is Monday morning, 8:00 - 8:45 am.
Class runs 9:00 am - 5:30 pm every day except Friday when it ends at 12:00 noon.
Special events include a reception for course participants and faculty on Monday night and a dinner on Thursday evening. All evening activities are included in tuition.
Product Lead, GlaxoSmithKline
"Good grounding in downstream processing which I will be able to apply to [my] day-to-day job."
Shift Manager, Recovery Manufacturing at Genentech
"I really enjoyed the course and felt that it strengthened my understanding of downstream processes and the considerations you have to make when designing a process."
Development Engineer II, Millipore Corporation
"Excellent, intellectually promising, and very informative."
Technical Service Representative, Eli Lilly and Company
"Course provides a comprehensive review of the key aspects of downstream processing from both a technical and economical perspective. Instructors are industry and academic leaders in biotech and provide insight into new technologies for existing application and new applications for existing technology."
senior scientist, amgen manufacturing ltd.
"Great balance between basics, advanced topics and academic, real-world applications."
analytical chemist, sweetwater energy
"The depth that the course went into in all aspects of downstream processing was quite sufficient. I was pleased to see not only the physical processes explained in great detail, but the economic modeling and the process design as well. Very enriching."
principal planner, genentech
"Top class staff were able to provide experience based rules of thumb and examples to clarify topics. Topics were relevant and well presented. In addition, the team project while helping students understand the material also helped the social aspect of being in Boston for a week."
bioprocess supervisor, genentech
"This was a very comprehensive course that gives and operational and business perspective one wouldn't get from operations."
senior engineer III, biogen idec
"Having a good understanding of downstream processing will help me and my upstream organization to work more cohesively with downstream so that we can better develop processes with a holistic mindset."
development technologist, fbs-FundaÇÃo BÊnÇÃos do senhor
"It is a great opportunity to learn new concepts and remember old ones with high level lectures and team interaction, summarizing it is a great experience."
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 at MIT
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, Academic Director of the Professional Science Master (PSM) Biotechnology Programs, Northeastern University, Boston, MA
About the Course Director
Charles L. Cooney
Robert T. Haslam Professor Emeritus, Department of Chemical Engineering
Professor Cooney obtained his bachelor’s degree in Chemical Engineering from the University of Pennsylvania and his master’s degree and PhD degree in Biochemical Engineering from MIT. After working briefly at the Squibb Institute for Medical Research, he joined the faculty of MIT as an Assistant Professor in 1970 and has been a full Professor since 1982. He has received the 1989 Gold Medal of the Institute of Biotechnological Studies (London); the Food, Pharmaceutical and Bioengineering Award from the American Institute of Chemical Engineers; and the James Van Lanen Distinguished Service Award from the American Chemical Society’s Division of Microbial and Biochemical Technology, and was elected to the American Institute of Medical and Biochemical Engineers. He serves as a consultant to and/or director of a number of biotech and pharmaceutical companies and is on several boards of professional journals.
This course takes place on the MIT campus in Cambridge, Massachusetts. We can also offer this course for groups of employees at your location. Please complete the Custom Programs request form for further details.
links & Resources