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?
Course materials blend the following pedagogical strategies to best achieve the learning objectives of the course and individual modules:
Week 1: Roadmap for Modern Biomanufacturing
- 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 2: Protein Structure & Function
- Roadmap to Modern Biomanufacturing
- Using Cells for Manufacturing
- Proteins as Therapeutics
- Course Structure and Expectations
Week 3: Cell Line Development
- Protein Structure
- Post Translational Modifications
- Function Examples
Week 4: Upstream Bioreactors
- Design of DNA Vectors for Protein Expression
- Selection of a Host for Production
- Vector Design for Mammalian Hosts
- Clonal Selection
Week 5: Downstream Processing
- Process Yield Calculation
- Bioreactor Design Features
- Mechanical Agitation
- Upstream Process Development
- Media Development
Week 6: Downstream Processing & Regulation
- Cell Harvest
- Filtration Unit Operation
- Depth Filtration
- Viral Clearance in Downstream Purification
- Process Control, Process Validation, and Product Testing
- Quality by Design
- Manufacturing Process Variants
J. Christopher Love, Stacy L. Springs and Paul W. Barone