The escalating costs of developing new ‘blockbuster’ drugs (those with sales >$1bn) and the increasing failure rate of promising new compounds at a late stage in development.
Intensifying competition from generic drugs, which dramatically reduce the potential for legacy earnings once patents have expired.
Increasing demands from regulators for a ‘Quality by Design’ approach that provides scientific evidence of properly controlled manufacturing processes being in place, rather than empirical evidence after production.
NiTech won the 2010 ICIS Innovation Award in the SME section for its continuous reactor technology that enables a biopharmaceutical product to be manufactured continuously. The NiTech Reactor in use at Genzyme has a 1 m3 volume, giving the same output as two 150 m3 pressurised stirred tank reactors.