Most pharmaceutical companies still rely on the old batch manufacturing method. Batch manufacturing implies inflexibility, high costs and poor biological delivery of more advanced new drugs. New manufacturing methods as Continuous Manufacturing, extruder-based Hot Melt Extrusion and Wet Granulation are the future, allowing for automation, improved efficiency, and proper bioavailability for poorly soluble molecules. Safety and fulfillment of such methods require more advanced Process Analytical Technology.
ColVisTec will extend its unique UV-VIS platform to incorporate NIR and Raman. IMPAX represents the first production monitoring platform to combine three spectra (UV-VIS, NIR, and Raman) and will provide extensive, real-time, spectroscopy measurements adapted to the extruder environment with pharma software compliant with EMA and FDA regulations.The initial markets will be Europe and the USA, where ColVisTec is already active. IMPAX users like pharma companies, contract manufacturers and universities will benefit from access to lower cost production and an innovative solution for drug delivery.
Important pharma stakeholders (AbbVie, Endcap, FCNW, Catalent, BASF and Reutlingen University) have already shown their interest and support in written form and undertaken to test the new IMPAX platform at their facilities.
IMPAX will contribute to Europe’s pharmaceutical industry by adopting “Industry 4.0” digitalization and automation principles and will facilitate the European market shift towards CM and PAT systems, boosting the uptake of more competitive manufacturing technologies.