Biotherapeutics are complex sets of molecules with numerous routes of both chemical and physical instability, which can manifest from development to manufacturing. Addressing these instabilities is a great challenge, because of the complexity of the biotherapeutics themselves, the mechanisms of instability, and the approaches to solve them.
This course addresses those challenges, focusing on globular proteins and antibodies, but also addressing peptides, vaccines, antibody-drug conjugates, and other modalities in a variety of situations from low to high concentration liquid formulations to lyophilized formulations to various manufacturing unit operations. The approach is to identify potential routes of instability as early on as discovery, and use rational and mechanistic approaches to solve them.
It is highly recommended that you apply for a course at least 6-8 weeks before the start date to guarantee there will be space available. After that date you may be placed on a waitlist. Courses with low enrollment may be cancelled up to 4 weeks before start date if sufficient enrollments are not met. If you are able to access the online application form, then registration for that particular course is still open.
The participants of this course will be able to:
- Understand the fundamentals of stabilization of biotherapeutics or biologics, including degradation mechanisms, rational design, and formulation
- Incorporate approaches to streamline stabilization during discovery, development, and manufacturing in your company
- Determine analytical approaches needed to solve various problems
- Understand the potential for cutting-edge approaches and technologies for a variety of modalities from antibodies to globular proteins, from peptides to vaccines and antibody-drug conjugates
Who Should Attend:
This course is targeted for scientists and engineers in biopharmaceutical discovery, development, and manufacturing. The course will be of particular benefit to those who wish to enhance their skills in rational approaches for stabilizing biotherapeutics. 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
- Biotherapeutic discovery scientists and engineers who want to incorporate developability and manufacturability into biotherapeutic design
- Scientists and engineers interested in physical and chemical processes that occur with biomolecules
- Managers responsible for pharmaceutical development, manufacturing, and regulatory affairs
Session 1--1.5 hours
Introduction, overview of instability issues and their relevance to discovery and product, process, and clinical development (Trout)
Session 2--1.5 hours
Chemical Instability: Analytics, mechanism, and control (Trout)
Session 3--1.5 hours
Regulatory Issues in Biotherapeutics (Damdinsuren)
Session 4--1.5 hours
Physical Instability: Conformational, colloidal, and interfacial mechanisms in aggregation and viscosity (Trout)
Session 5--1.5 hours
Analytical Methods for Physical Instability (Manning)
Session 6--1.5 hours
Rational Development of Low and High Concentration Liquid Formulations (Manning)
Session 7--1.5 hours
Rational Development of Frozen and Lyophilized Formulations (Manning)
Session 8--1.5 hours
Rational Design from Discovery to Development and Manufacturing and Applications of Learnings so far to Peptides, Vaccines, and Antibody-Drug Conjugates (Trout/Manning)
Session 9--1.5 hours
Addressing Instability Issues in Manufacturing and Packaging (Manning)
Session 10--1.5 hours
Case Studies from High-Concentration Subcutaneous Injection to Multi-dose Liquid Formulations (Manning)
Session 11--1.5 hours
Discussion: Marketed product discussion/problems from audience (Manning/Trout)
View 2018 Schedule (pdf)
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
PRESIDENT AND CEO, ENZYMERX
"The quality was very high across the board."
"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."
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."
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."
RESEARCH ASSISTANT, BIOGEN IDEC
"One instructor was from the FDA; her topic was relevant and it was great to have her participating in class."
TECHNICAL SPECIALIST, GENENTECH
"I very much liked the course because it covered all sorts of issues from early discovery through fermentation, purification, formulation, drug product all the way to regulatory issues. I found the examples and the case studies which were presented in this course were very educational."
Bernhardt L. Trout is the Raymond F. Baddour, ScD, (1949) Professor of Chemical Engineering and Director of the Novartis-MIT Center for Continuous Manufacturing. 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.
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, with several colleagues from MIT, he set up the Novartis-MIT Center for Continuous Manufacturing, a $85 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 190 papers and has 22 patents issued or pending.
Dr. Mark Manning is Chief Scientific Officer, Legacy BioDesign, LLC. 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, widely considered to be the leading educational program in the country for training formulation scientists to handle biotechnology-based products. Manning has consulted for more than 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. Manning has published over 100 scientific articles, holds five U.S. patents, and has edited three books on protein formulation. 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.
Bazarragchaa Damdinsuren, M.D. Drug Quality Reviewer, Office of Biotechnology Products, Office of Pharmaceutical Quality, CDER, FDA Bazarragchaa Damdinsuren received his M.D. from National Medical University in Mongolia and his Ph.D. from Osaka University, Japan. He holds Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professionals Society (RAPS). He has published over 40 scientific articles.
After completion of his postdoc in immunology and cell biology at the National Institutes of Health (NIH), Damdinsuren joined the FDA as a Commissioner’s Fellow in 2010. At his current position in the Office of Biotechnology Products, he is responsible for reviewing the product quality and manufacturing controls of therapeutic monoclonal antibodies, antibody derivatives (Fc fusion proteins, Fab, etc.), antibody drug conjugates, and biosimilars to antibody products.
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.
|Fundamentals: Core concepts, understandings, and tools (30%)||30|
|Latest Developments: Recent advances and future trends (30%)||30|
|Industry Applications: Linking theory and real-world (25%)||25|
|Other: Decision making and designing for change (15%)||15|
|Lecture: Delivery of material in a lecture format (65%)||65|
|Discussion or Groupwork: Participatory learning (25%)||25|
|Labs: Demonstrations, experiments, simulations (10%)||10|
|Introductory: Appropriate for a general audience (10%)||10|
|Specialized: Assumes experience in practice area or field (70%)||70|
|Advanced: In-depth exploration at the graduate level (20%)||20|