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
relevant documents).
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
proteins.
a. Provide a process flow diagram of the process (examples of proteins like antibodies, vaccines, etc)