biopharmeceutical therapeutic

I have picked KYMRIAH… 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

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