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Lead Instructor(s)
Participating Instructor(s)
Course Length
4 Days
Course Fee
2.1 CEUs
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Designed for scientists and engineers working in biopharmaceutical discovery, development, and manufacturing, this dynamic four-day course explores various strategies for overcoming challenges related to the stability, solubility, and viscosity of biotherapeutics. There is a focus on a fundamental mechanistic understanding of protein stability, providing the basis for formulating and stabilizing biopharmaceuticals. The course will also present advances in emerging areas, such as cell and gene therapy as well as machine learning.


Course Overview


Biotherapeutics are complex molecular species with numerous routes of both chemical and physical instability, which can manifest from discovery through development and manufacturing. Addressing these instabilities presents a sizable challenge, because of the complexity of the biotherapeutics themselves and the multiplicity of degradation mechanisms.

This course addresses those challenges, with a focus on mechanistic understanding leading to rational strategies for formulation and stabilization. Numerous modalities are addressed, from globular proteins and monoclonal antibodies to peptides, vaccines, antibody-drug conjugates, oligonucleotides, cell therapy, and gene therapy. Formulations can include liquid dosage forms that range from low to high concentration along with frozen and lyophilized compositions. Stability and drug delivery issues are presented including their association with packaging, devices, and bioprocessing. Cutting-edge approaches are also included, such as physico-chemical-based predictive methods and machine learning.

Certificate of Completion from MIT Professional Education

Formulation cert image
Learning Outcomes
  • 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

Please note that the course schedule is subject to change.

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 

Session 2--1.5 hours
Chemical Instability: Analytics, Mechanism, and Control 

Session 3--1.5 hours
Physical Instability: Conformational, Colloidal, and Interfacial Mechanisms in Aggregation and Viscosity 

Session 4--1.5 hours
Instability Issues in Context, Break-out groups with problems, Report back, Initial Discussion of Projects 

Day Two

Session 5--1.5 hours
Overview of Analytical Methods: Methods to Characterize Aggregates and Particulates 

Session 6--1.5 hours
Rational Development of Low and High Concentration Liquid Formulations 

Session 7--1.5 hours
Regulatory Considerations for Biotherapeutics 

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 

Session 10--1.5 hours
Case Studies in Addressing Formulation Challenges 

Session 11--1.5 hours
Addressing Stability Problems as they Relate to Biopharmaceutical Manufacturing and Packaging 

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

Links & Resources


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


"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."
"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."
"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."
"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."
Download the Course Brochure
Formulation and Stabilization of Biotherapeutics - Brochure Image

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.

Fundamentals: Core concepts, understandings, and tools - 30%|Latest Developments: Recent advances and future trends - 30%|Industry Applications: Linking theory and real-world - 25%|Other: Decision making and designing for change - 15%
Delivery Methods

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.

Lecture: Delivery of material in a lecture format - 65%|Discussion or Groupwork: Participatory learning - 25%|Labs: Demonstrations, experiments, simulations - 10%

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.

Introductory: Appropriate for a general audience - 10%|Specialized: Assumes experience in practice area or field - 70%|Advanced: In-depth exploration at the graduate level - 20%