Short Programs

Downstream Processing

Date: August 5-9, 2013 | Tuition: $4,050 | Continuing Education Units (CEUs): 2.7
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Overview  |  Learning Objectives  |  Who Should Attend  |  Course Format  |  Outline of the Course  |  Course Schedule  |  Participants' Comments  |  Staff  |  About the Course Director  |  Location  |  Updates

Overview

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, will generate sales exceeding $120 billion in 2012. 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.

Learning Objectives

• Define 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.
• Model biochemical product recovery, including small molecule purification.
• Examine strategies for biochemical process synthesis.
• Address centrifugation, cell disruption, chromatography, crystallization, filtration, liquid-liquid extraction, membrane processes, process economics, process synthesis and simulation, protein refolding, 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 wanting an overview and insight into biochemical manufacturing.

Course Format

The course faculty have worked together for over twenty-five 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 5:00 pm each day except Friday when they finish by 12:00 noon. There is a reception for all participants on Monday from 6:00 pm to 8:00 pm and a banquet on Thursday evening from 6:00 pm to 9:00 pm.

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
• Cell disruption
• Centrifugation
• Chromatography
• Therapeutic protein characterization and comparability
• Filtration fundamentals
• Extraction case study
• Process synthesis
• Process 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

Class runs 9:00 am - 5:00 pm every day except Friday when it ends at 12:00 noon.

Registration is on Monday morning from 8:00 - 8:45 am.

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.

Participants' Comments

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."

Staff

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. Daniel I.C. Wang, Institute Professor of Chemical Engineering, Department of Chemical Engineering at MIT

Mr. Jean-Francois Hamel, MIT, runs the teams projects

Mr. Robert Baffi, Executive Vice President of Technical Operations, Bio Marin Pharmaceutical Inc, Novato, CA

About the Course Director

Charles L. Cooney
Charles L. Cooney - Robert T. Haslam Professor
Professor of Chemical and Biochemical Engineering and Faculty Director of the Deshpande Center for Technological Innovation at MIT, Cambridge, Massachusetts
He 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.

Location

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 contact the Short Programs office for further details.