Formulation and Stabilization of Biotherapeutics

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.

Lead Instructor(s): 

Bernhardt L. Trout
Mark Manning

Dates: 

Jun 10, 2019 - Jun 13, 2019

Course Length: 

4 Days

Course Fee: 

$3,900

CEUs: 

2.2

Status: 

  • Closed

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.

Registration for this program is closed for Summer 2019.

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

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

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

Course Schedule: 

View 2019 Schedule (pdf)

Please note that the 2019 schedule is subject to change.

 

Participants’ Comments: 

PRESIDENT AND CEO, ENZYMERX

"The quality was very high across the board."

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."

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."

Instructors: 

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 complete the Custom Programs request form for further details.

Content: 

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

 

Delivery Methods: 

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

 

Levels: 

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