Pharmaceuticals and Fine Chemicals

NiTech® reactors and crystallizers are perfect for the pharma/fine chemicals sector.

The technology is well aligned with emerging needs for lower cost, higher quality manufacturing processes that reduce carbon footprint. NiTech’s technology supports the major changes taking place in the 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 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.

Read Genzyme Case Study

Real Vision interview with Paul Hodges: Pharmaceuticals sector local supply chains

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

Sanofi Genzyme continuous pharma API plant

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

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.

NiTech Solutions and Corning have successfully demonstrated a continuous processing system that integrates a NiTech® continuous crystallizer and continuous filtration equipment from Alconbury Weston Limited (AWL) with Corning’s® Advanced-Flow™ reactor (AFR™).

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 crystallizer, can be easily and seamlessly transferred to industrial production involving thousands of tonnes per year.

Corning Advanced Flow reactor AFR