1. Stem cell therapies
a. How would you prepare a biomanufacturing process for this technology? (minimum 1-page description)
b. Provide some key steps in the process
c. What might be 4 main GMP-related concerns or challenges?
2. Advanced biomanufacturing involves several new technologies
a. List some key GMP manufacturing documents that might be relevant for these technologies (find minimum 5
b. What are some key GMP challenges involved with Gene therapies?
3. Highlight some key elements in the process flow and unit operation involved with manufacturing recombinant
a. Provide a process flow diagram of the process (examples of proteins like antibodies, vaccines, etc)