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.
NiTech’s® continuous reactor has replaced two stirred tank reactors (STRs), each of 150m3, leading to a reduction in reactor volume of 99.6%.
Sanofi has subsequently taken a second licence with NiTech Solutions.
The integrated system provides a global solution for continuous synthesis and downstream processes for pharmaceutical, fine, and specialty chemical companies.
The test, which was performed at lab scale using a DN15 Lite crystalliser, can be easily and seamlessly transferred to industrial production involving thousands of tonnes per year.