Short Programs
Crystallization Science and Technology in the Pharmaceutical Industry [10.40s]
Date: July 26-28, 2010 | Tuition: $2,200 | Continuing Education Units (CEUs): 1.8
Course Summary | Learning Objectives | Who Should Attend | Program Outline | Participants' Comments | On-Site Courses | About the Lecturers | Updates
Course Summary
Crystallization is a key component of almost all processes in the manufacturing of small molecule pharmaceuticals. Whether for purification of intermediates, formation of the product, or prevention of crystallization in amorphous products, crystallization is always a key aspect of pharmaceutical manufacturing and development. While the basics of crystallization, such as the fundamentals of thermodynamics, kinetics, and structure, are well established, the application of these basics to solve crystallization process problems is complicated with a large number of tools for the practicing scientist or engineer to make use of. How should one explore the field for the most useful tools with limited time? How to know what tool or tools will work best for a given problem? What are the cutting edge approaches to crystallization that can provide maximum benefit? This course addresses these questions and more.
The course will focus on the fundamentals of crystallization with an emphasis on problem solving. Control of crystal size distributions, polymorphs, impurity-crystal interactions, and morphology are a few of the key areas that will be discussed with multiple approaches evaluated. The design of reactors and processes to yield optimal products will be a key aspect. In addition, cutting-edge technologies will be assessed. The entire course will emphasize enhancing both development and manufacturing efficiency.
Fundamentals: Core concepts, understandings and tools (30%)
Latest Developments: Recent advances and future trends (25%)
Industry Applications: Linking theory and real-world (30%)
Other: Decision making and designing for change (15%)
Lecture: Delivery of material in a lecture format (50%)
Discussion or Groupwork: Participatory learning (40%)
Labs: Demonstrations, experiments, simulations (10%)
Introductory: Appropriate for a general audience (10%)
Specialized: Assumes experience in practice area or field (70%)
Advanced: In-depth explorations at the graduate level (20%)
Learning Objectives
The participants of this course will be able to:
- Define fundamentals of pharmaceutical crystallization.
- Identify ways to enhance the efficiency of crystallization processes.
- Apply state of the art techniques to crystallization development and manufacturing.
- Analyze strategic approaches to crystallization.
- Incorporate modeling approaches into the development of crystallization processes.
- Apply knowledge of cutting-edge pharmaceutical crystallization technologies.
Who Should Attend
This course is targeted for scientists and engineers in pharmaceutical development and manufacturing for whom crystallization plays a role in their work. The course will be of particular benefit to those who wish to enhance their skill in efficiently and effectively solving technological problems that arise in pharmaceutical crystallization. Those who should attend include:
- Chemists, pharmaceutical scientists, and engineers in pharmaceutical manufacturing
- Chemists, pharmaceutical scientists, and engineers in pharmaceutical development
- Managers responsible for pharmaceutical development, manufacturing, and regulatory affairs
Program Outline
Day One
Session 1--1.5 hours
Introduction, Solubility and Supersaturation
Break
Session 2--1.5 hours
Crystals, Crystal Growth and Nucleation
Lunch
Session 3--1.5 hours
Polymorphism
Break
Session 4--1.5 hours
Introduction to Modeling, Prediction of Morphology, Calculation of X-ray patterns
Day Two
Session 5--1.5 hours
Particle Size Distribution Analysis, Batch Crystallization
Break
Session 6--1.5 hours
Batch Process Development, Seeding
Lunch
Session 7--1.5 hours
Solubility Predictions
Break
Session 8--1.5 hours
Process Analytical Technology
Day Three
Session 9--1.5 hours
Continuous Crystallization
Break
Session 10--1.5 hours
Discussion: Problems from Audience / Case Studies
Lunch
Session 11--1.5 hours
Frontier Modeling Technologies in Crystallization
Course schedule and registration times
8:30 am - 10:00 am - Session
10:00 am -10:30 am - Break
10:30 am - 12:00 pm -Session
12:00 pm - 1:30 pm - Lunch
1:30 pm - 3:00 pm -Session
3:00 pm - 3:30 pm - Break
3:30 pm - 5:00 pm -Session
Class ends at 3:00 pm on Wednesday.
Registration is on Monday morning from 7:30 - 8:15 am.
Participants' Comments
Senior Regulatory Affairs Specialist, Infinity Pharmaceuticals
“I really benefited from learning the fundamentals of crystallization, polymorphs, crystal morphology, etc. As a non-chemist, I felt I took away a great background that I could apply to my job.”
Associate Scientist II, Gilead Alberta ULC
“The course I took was well explained and the outline was very easy to follow. The campus was beautiful and the state of the art technology was amazing.”
Fellow, Novartis Pharmaceuticals Corporation
“Comprehensive overview of science and engineering as applied to pharmaceuticals.”
On-site Courses
We can also offer this course for groups of employees at your location. Please contact the Short Programs office for further details.
About The Lecturers
Prof. Allan S. Myerson
Allan S. Myerson is the Philip Danforth Amour Professor of Engineering at the Illinois Institute of Technology (IIT) in Chicago. Dr. Myerson served as Provost and Senior Vice President at IIT (January 2003-June 2008) and Dean of Engineering and Science (January 2000-January 2003). Prior to his position at IIT Professor Myerson served on the faculty at Polytechnic University (NY), Georgia Institute of Technology, and the University of Dayton. Professor Myerson was educated at Columbia University (B.S.) the University of Virginia (M.S. and Ph.D.).
Professor Myerson’s research focuses on separations processes in the chemical and pharmaceutical industry with an emphasis on crystallization from solution. He has published 5 books, including the Handbook of Industrial Crystallization 150 papers and is the inventor on 32 US patents. Professor Myerson serves as associate editor of Crystal Growth and Design, a journal published by the ACS. Professor Myerson has consulted for approximately 100 companies worldwide and was honored in 2008 with the American Chemical Society Award in Separations Science and Technology.
For more information on the Prof. Myerson and his research, please visit http://www.iit.edu/engineering/chbe/faculty/myerson_allan.shtml.
Prof. Bernhardt L. Trout
Bernhardt L. Trout is a Professor of Chemical Engineering at MIT. He is currently Director of the Novartis-MIT Center for Continuous Manufacturing and the Co-Chair of the Singapore-MIT Alliance Program on Chemical and Pharmaceutical Engineering. He received his S.B. and S.M. degrees from MIT and his Ph.D. from the University of California at Berkeley. In addition, he performed post-doctoral research at the Max-Planck Institute.
Prof. Trout’s research focuses on molecular engineering, specifically the development and application of both computational and experimental molecular based methods to engineering chemical products and processes with unprecedented specificity. Since 2000, he has focused on molecular engineering for crystallization, formulation, and the development of pharmaceutical separation processes. In 2007, together with several colleagues from MIT, he set up the Novartis-MIT Center for Continuous Manufacturing, a $65 million partnership with the objective of transforming pharmaceutical manufacturing. In addition to Novartis, he has worked with many other pharmaceutical companies in research or consulting. He has published over 70 papers and currently has 4 patent applications submitted.
For more information on Prof. Trout and his research, please visit http://web.mit.edu/troutgroup/.
Updates
There are no updates at this time.
