Pharmaceuticals and Fine Chemicals

NiTech Solutions reactors and crystallizers are perfect for the pharmaceuticals and fine chemicals sector.

The technology is well aligned with emerging needs for lower cost, higher quality manufacturing processes that reduce carbon footprint. It enables accurate monitoring of critical process parameters, which supports ever-increasing regulatory standards/requirements. NiTech Solutions technology supports the major changes taking place in the pharmaceuticals and fine chemicals sector’s business model as a result of:

  • 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.

2010 ICIS Innovation Award

NiTech Solutions 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 Solutions reactor in use at Genzyme has a 1 m3 volume, giving the same output as two 150 m3 pressurised stirred tank reactors.

NiTech Solutions is now working with 7 of the Top 10 companies in the pharmaceuticals sector, as well as companies who are important ‘thought leaders’ in the engineering and manufacturing supply chain.

The world’s largest patent-protected continuous pharma API plant is at Sanofi Genzyme in Haverhill, UK, where a NiTech Solutions continuous reactor has been used as part of a key synthesis step handling three phases since April 2007.

A NiTech Solutions 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.

Sanofi Genzyme continuous pharma API plant for Pharmaceuticals and Fine Chemicals