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Inline/Instant Measurement for PhArma eXtrusion

Objective

Most pharma companies still rely on the age old batch manufacturing method and today the European Pharma industry faces the major challenge of strong competition from lower cost manufacturers. The trend is disinvestment in Europe or alternatively investment in innovative manufacturing technologies and more advanced and targeted pharmacological products.

Batch manufacturing implies inflexibility, high costs and poor biological delivery of more advanced new drugs. New techniques like 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 fulfilment of their potential mean these new processes require much more advanced Process Analytical Technology than is currently available.

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 pharma industry adopting “Industry 4.0” digitalisation and automation principles and will facilitate the European market shift towards CM and PAT techniques boosting the uptake of more competitive manufacturing technologies.

Call for proposal

H2020-SMEINST-2-2016-2017
See other projects for this call

Funding Scheme

SME-2 - SME instrument phase 2
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

COLVISTEC AG
Address
Max-planck-strasse 3
12489 Berlin
Germany
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
EU contribution
€ 2 293 471,25