biopharmeceutical therapeutic
I have picked KYMRIAH https://www.us.kymriah.com/acute-lymphoblastic-leu… as the biopharmeceutical therapeutic and need answers and research to answer the fallowing questions. I will need slides answering each of the fallowing bullets and also script for each slide explaining them.
Each group will research, compile, and present a 15-20 minute powerpoint presentation on a biopharmaceutical therapeutic, to address topics covered in class including but not limited to:
·Title slide- Drug name, manufacturer (and location)
·Diseases/disorders treated, mechanism of action
·Primary research- where completed, academia vs. industry, summary of findings
·Intellectual property status (patent year, patent type(s), indications, biosimilar status?)
·Development genetics
·Platform technology- protein or antibody
·Host cells and upstream production details (culture media/conditions, scale-up, process control strategies)
·Cell bank system(s) utilized
·Downstream product recovery and purification
·Product formulation, fill-finish
·Advanced strategies used (PAT, QBD, Continuous processing)
·Active substance testing, product stability, bio-burden
·Clinical trials and FDA approval process
·Annual sales revenue, market share, other drugs in class, US approval, EU approval? other approvals? Post-market research? Evidence of drug re-purposing? Future outlook?
·References slide