THIS COURSE MAY BE TAKEN INDIVIDUALLY OR AS part of THE PROFESSIONAL CERTIFICATE PROGRAM IN BIOTECHNOLOGY & LIFE SCIENCES.
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.
- 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
Please note that the 2020 schedule is subject to change.
Session 1--1.5 hours
Introduction, Overview of Instability Issues and Their Relevance to Discovery and Product, Process, and Clinical Development; Physical Instability (Trout)
Session 2--1.5 hours
Chemical Instability: Analytics, Mechanism, and Control (Trout)
Session 3--1.5 hours
Physical Instability: Conformational, Colloidal, and Interfacial Mechanisms in Aggregation and Viscosity (Trout)
Session 4--1.5 hours
Instability Issues in Context, Break-out groups with problems, Report back, Initial Discussion of Projects (All)
Session 5--1.5 hours
Overview of Analytical Methods: Methods to Characterize Aggregates and Particulates (Manning)
Session 6--1.5 hours
Rational Development of Low and High Concentration Liquid Formulations (Manning)
Session 7--1.5 hours
Regulatory Considerations for Biotherapeutics (Damdinsuren)
Session 8--1.5 hours
Formulation challenge, Break-out Groups, Report
Session 9--1.5 hours
Rational Development of Frozen and Dried Formulations (Manning)
Session 10--1.5 hours
Case Studies in Addressing Formulation Challenges (Manning/Trout)
Session 11--1.5 hours
Addressing Stability Problems as they Relate to Biopharmaceutical Manufacturing and Packaging (Manning)
Session 12--1.5 hours
Break-out groups, Work on project, Report
Session 13--1.5 hours
Special Formulation Challenges: Peptides, Vaccines, ADCs, RNA Products, PEGylated Products
Session 14--1.5 hours
Final Project Reports and Final Discussion
Links & Resources
- Continuous drug manufacturing offers speed, lower costs - Professor Trout's other research developing a prototype continuous-manufacturing system
- Inside an innovation ecosystem - History, proximity, and serendipity make Kendall Square fertile ground for the next big idea.
- American made? - MIT forum examines the role of manufacturing in rebuilding the economy.
- Predictive tools for stabilization of therapeutic proteins
The type of content you will learn in this course, whether it's a foundational understanding of the subject, the hottest trends and developments in the field, or suggested practical applications for industry.
How the course is taught, from traditional classroom lectures and riveting discussions to group projects to engaging and interactive simulations and exercises with your peers.
What level of expertise and familiarity the material in this course assumes you have. The greater the amount of introductory material taught in the course, the less you will need to be familiar with when you attend.