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MIT Professional Education

Formulation and Stabilization of Biotherapeutics

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Next dates

Jun 10—13
4 days
Cambridge, Massachusetts, USA
USD 3900
USD 975 per day

Description

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.

PARTICIPANT TAKEAWAYS

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

PROGRAM OUTLINE

Day One

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)

Day Two

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

Day Three

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

Day Four

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

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

Experts

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 ...
Dr. Mark Manning is 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...
Bazarragchaa Damdinsuren, M.D. is 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 C...
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