Short Programs

Formulation and Stabilization of Biotherapeutics [10.50s]

Date: July 9-11, 2012 | Tuition: $2,200 | Continuing Education Units (CEUs): 1.5
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Course Summary  |  Learning Objectives  |  Who Should Attend  |  Program Outline  |  Schedule  | 
Participants' Comments  |  About the Lecturers  |  Location  |  Links & Resources  |  Updates

Course Summary

Biotherapeutics, particularly antibodies, are currently the fastest growing pharmaceuticals. Ideally, they are formulated in aqueous solutions, often a great challenge due to physical and chemical stability issues. This course addresses those challenges across a range of topics from aggregation to oxidation, deamidation, and hydrolysis. It covers these topics from the basic to the advanced level with an emphasis on modeling. In addition, cutting-edge technologies are described and analyzed. The course as a whole focuses on giving you additional tools and knowledge to help streamline solutions to formulation and stability issues for biologics.

Learning Objectives

The participants of this course will be able to:

• Define the fundamentals of formulation and stabilization of biotherapeutics or biologics
• Incorporate approaches to streamline formulation development in your company
• Examine issues of stability of biotherapeutics during manufacturing
• Determine analytical approaches needed to solve various problems
• Understand the potential for cutting-edge approaches and technologies

Who Should Attend

This course is targeted for scientists and engineers in biopharmaceutical development. It would also be of interest to those in biomanufacturing, in which stability issues perpetually arise. The course will be of particular benefit to those who wish to enhance their skill in efficiently and effectively addressing stability issues and formulation. Those who should attend include:

• Formulation scientists from beginning to advanced
• Scientists and engineers who are interested in or need to understand stability issues
• Bioprocessing scientists and engineers
• Scientists and engineers interested in physical and chemical processes that occur with biomolecules
• Managers responsible for pharmaceutical development, manufacturing, and regulatory affairs

Program Outline

Day One

Session 1--1.5 hours
Introduction, Degradation Routes, Quality by Design in Formulation, General Approach to Formulation and Key Issues, Physical Stability Issues, Understanding the Routes of Physical Instability, and Modeling for Streamlining Stabilization Against Physical Degradation (Trout)

Break

Session 2--1.5 hours
Chemical Stability Issues, Understanding the Routes of Chemical Instability, and Modeling for Streamlining Stabilization Against Chemical Degradation (Trout)

Lunch (provided)

Session 3--1.5 hours
Rational Development of Liquid Protein Formulations (Manning)

Break

Session 4--1.5 hours
Rational Development of Dried and High Concentration Protein Formulations (Manning)

Day Two

Session 5--1.5 hours
Overview of Analytical Methods in Industrial Formulation Development (Trout)

Break

Session 6--1.5 hours
Strategies for Formulation Development of Therapeutic Proteins and Modified Proteins (Manning)

Lunch (provided)

Session 7--1.5 hours
Thermodynamics and Kinetic Parameter Analysis in Biopharmaceutical Stabilization (Trout)

Break

Session 8--1.5 hours
Application of Techniques and Computer Modeling (in computer lab), Laboratory Tour and Demonstration (Trout)

Day Three

Session 9--1.5 hours
Regulatory Issues in Therapeutic Monoclonal Antibodies and Perspective on Aggregates in Biotechnology Products (Audrey Jia)

Break

Session 10--1.5 hours
Protein Stability Issues during Biomanufacturing Operations (Manning)

Lunch (provided)

Session 11--1.5 hours
Discussion: Problems from Audience / Case Studies (Manning/Trout)

Course schedule and registration times

Class runs 9:00 am - 5:00 pm each day except for Wednesday when it ends at 3:00 pm.

9:00 am - 10:30 am - Session
10:30 am - 11:00 am - Break
11:00 am - 12:30 pm - Session
12:30 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

Registration is on Monday morning from 8:00 - 8:30 am.

Participants' Comments

Tony Fiorino, President and CEO, EnzymeRx
"The quality was very high across the board."

Shelby Latchford, Scientist, GlaxoSmithKline
"The course and the lecturers had a great wealth of the past, present, and future and did a good job of presenting the analytical tools and applications of formulation related topics. Faculty were easy to talk to, ask questions to, and openly discuss with."

Jan Jezek, Principal Scientist, Arecor Ltd
"All lecturers managed to maintain my complete attention for the duration of their lectures, which is a sign of a good and well prepared teacher. A very good overview of many aspects of the formulation science."

Manasi Puri, Associate Scientist, GlaxoSmithKline
"The most beneficial aspect of the course is the top knowledge of the lecturers allowing one to gain confidence in acquiring the latest advancement in specific field of interest and also references to various literature articles out there for more information. [Professors] Trout and Manning were excellent in terms of answering all the questions during and after the course."

About the Lecturers

Bernhardt L. Trout, Ph. D.
Professor, Department of Chemical Engineering, MIT
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.

Professor Trout’s research focuses on molecular engineering, specifically the development and application of both computational and experimental molecular-based methods to engineering pharmaceutical formulations and processes with unprecedented specificity. Since 1999, he has focused on molecular engineering for biopharmaceutical formulation, primarily liquid formulation, but also lyophilized formulation. A major aspect of his research focuses on developing both microscopic and macroscopic models to design stable formulations efficiently. 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 100 papers and currently has 6 patent applications submitted.

For more information on Prof. Trout and his research, please visit
http://web.mit.edu/troutgroup/.

Dr. Mark Manning, Ph.D.
Chief Scientific Officer, Legacy BioDesign, LLC
Dr. Manning has been involved in the development of biopharmaceutical products since 1988, when he joined the faculty at the University of Kansas. He then moved to the University of Colorado, where he helped found the Center for Pharmaceutical Biotechnology, what is widely considered to be the leading educational program in the country for training formulation scientists to handle biotechnology-based products. Dr. Manning has consulted for over 40 companies on a wide variety of projects. In addition, he has directed numerous formulation development projects for clients, first as Chief Technical Officer for HTD BioSystems and then as Chief Scientific Officer for Legacy BioDesign. Dr. Manning has published over 100 scientific articles, holds five U.S. patents, and has edited three books on protein formulation. Dr. Manning received an A.B. degree in chemistry from Hope College and his M.S. and Ph.D. degrees from Northwestern University. He conducted post-doctoral work at Colorado State University.

Audrey Jia, M.D., Ph.D, M.S.
Division of Monoclonal Antibodies, Office of Biotechnology Products, FDA
Dr. Audrey Jia is a quality reviewer for monoclonal antibody and related products in the Division of Monoclonal antibodies in the Office of Biotechnology Products at the Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA). She received her M.D. degree from Peking University in China, her Ph.D. in Biochemical Science from Emory University, and her M.S. in Bioscience Regulatory Affairs from The Johns Hopkins University.

Dr. Jia worked in the monoclonal antibody research and development field in biopharmaceutical companies for 10 years, working with monoclonal antibody engineering, high-producing cell line generations, cell cultures, and purifications in PDL BioPharma, Inc, Facet Biotech, Inc., and Pfizer, Inc. from 1999 to 2009. In 2009, she joined the FDA, where she is responsible for reviewing the whole gamut of the chemistry and manufacturing controls of monoclonal antibodies, antibody derivatives (Fc fusion proteins, Fab, ScFv etc), antibody drug conjugates, and radiolabeled antibody products.

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.

Links & Resources

News/Articles:

• Continuous drug manufacturing offers speed, lower costs - Professor Trout's other research developing a prototype continuous-manufacturing system

Updates

There are no updates at this time.