The rise of personalised medicines has led to the focus on small scale manufacture with a key challenge being that lots of the same element will run through a facility at once. Randomised trials with complex gene therapies- which target a small number of patients often in regards to orphan diseases can encounter various manufacturing hurdles. Also, evidence is needed to prove efficacy against historical controls with Phase II trials. This of course requires several years of data which is limited, incurring implications on cost and time to market.
Ahead of the Cell and Gene Therapy Manufacturing conference Pharma IQ examines the various challenges that complicate the route to producing off the shelf cell and gene products.
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