In this case study, Pharma IQ gains insight from Oxford BioMedica - a pioneer in the development of gene therapies for 20 years, focused mainly on lentiviral vectors. The ebook evaluates manufacturing trends, preparing for the commercial phases of gene therapies, combating extractables and leachables and scaling up.
In response to the region’s strengthening presence with the therapeutic method, Pharma IQ presents this Cell and Gene Manufacturing hotspot map.
Over the last 12 months, the cell and gene therapy manufacturing sphere has matured vastly with more companies advancing to commercial products, especially with allogenic therapies. Now that the theory behind the therapy is catching up with the technology, the two can come together to progress towards producing commercial products. Last year Pharma IQ examined the UK with our Cell and Gene Manufacturing hotspot map. This year we broaden our focus to scan the cell and gene manufacturing activity that is occurring across Europe regarding the road to commercialised therapies.
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.