• Length:
    6 Weeks
  • Effort:
    3–5 hours per week
  • Price:
    $199 USD
  • Institution
  • Subject:
  • Level:
    Introductory
  • Language:
    English
  • Video Transcript:
    English

Prerequisites

The course is open to any interested participant. No advance reading is required. The faculty strongly recommend participants have a basic understanding of organic chemistry, calculus, and molecular biology.

About this course

The successful manufacturing of biologic medicines requires strong collaboration among multiple functional groups. Yet, many organizations are heavily siloed and fragmented communication across divisions can slow progress towards producing medicines for patients. Could your organization be working more effectively and efficiently?

Using an applied case study, the program offers scientists, chemists, researchers, program managers, and other biological medicine specialists an opportunity to build an integrated understanding to their role in biomanufacturing.

By the end of this course, you will understand how decisions made as early as product discovery can impact how a biologic is manufactured and delivered. You will also be able to answer questions such as:
  • How do you design biopharmaceutical medicines to be both effective and manufacturable?

  • How do you co-op cellular machinery to produce life-saving medicines?

  • How do you design reactors to keep the cellular factories happy and productive?

  • How do you remove cellular debris for the highest quality and most efficacious therapy?

  • Faster decision times could add risks associated with accelerated development of compounds, so how do you do all of this as efficiently as possible in a highly regulated environment?

What you'll learn

  • Discover how small changes in a protein therapeutic may change its efficacy, safety and manufacturability.
  • Understand the method by which living cells are engineered to produce complex therapeutic proteins.
  • Explore the way in which reactors are designed to support the growth of living cells that produce a target therapeutic.
  • Learn how protein therapeutics are purified and how previous manufacturing steps inform how this is performed.
  • Identify the keys to manufacture biopharmaceuticals in a regulated environment and analyze examples and case studies highlighting key biomanufacturing challenges.
Course materials blend the following pedagogical strategies to best achieve the learning objectives of the course and individual modules:
  • Instructivism: Teacher-centered learning where the instructors present relevant content (tutorial videos enhanced with animation and graphics). Students will test their knowledge through graded tests.

  • Constructivism: Learning by doing approach. We encourage learners to construct their own understanding through solving the mandatory and optional case studies and practicing.

  • Social Constructivism: Learning through social interactions and communication. You will be able to discuss with your peers in the discussion groups, and evaluate and get reviews from your peers through two compulsory case studies.

  • Connectivism: Connecting with others and extending your knowledge through communication. You will be able to expand and share your knowledge with others through the Discussion group.


Week 1: Roadmap for Modern Biomanufacturing
  • Roadmap to Modern Biomanufacturing
  • Using Cells for Manufacturing
  • Proteins as Therapeutics
  • Course Structure and Expectations

Week 2: Protein Structure & Function
  • Protein Structure
  • Post Translational Modifications
  • Function Examples

Week 3: Cell Line Development
  • Design of DNA Vectors for Protein Expression
  • Selection of a Host for Production
  • Vector Design for Mammalian Hosts
  • Clonal Selection


Week 4: Upstream Bioreactors
  • Process Yield Calculation
  • Bioreactor Design Features
  • Mechanical Agitation
  • Upstream Process Development
  • Media Development

Week 5: Downstream Processing
  • Cell Harvest
  • Filtration Unit Operation
  • Depth Filtration
  • Ultrafiltration


Week 6: Downstream Processing & Regulation
  • Chromatography
  • Viral Clearance in Downstream Purification
  • Process Control, Process Validation, and Product Testing
  • Quality by Design
  • Manufacturing Process Variants

Meet your instructors

J. Christopher Love
Associate Professor of Chemical Engineering
Koch Institute for Integrative Cancer Research at MIT
Stacy L. Springs
Director of the Biomanufacturing Research Program (BioMAN)
MIT Center for Biomedical Innovation
Paul W. Barone
Associate Director of the Biomanufacturing Research Program (BioMAN)
MIT Center for Biomedical Innovation (CBI)

Learner testimonials

"The course content and flow exceed my expectations. The material provided a great overview of the bio-manufacturing process and challenged my thinking when it came to scaling up from the lab scale to the commercial scale. The video presentations are very professional and added great value to the course." - Spring 2018 Course Participant