IMPAX SIGNED
Inline/Instant Measurement for PhArma eXtrusion
Total Cost €
0EC-Contrib. €
0Partnership
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0IMPAX project word cloud
Explore the words cloud of the IMPAX project. It provides you a very rough idea of what is the project "IMPAX" about.
Project "IMPAX" data sheet
The following table provides information about the project.
| Coordinator |
COLVISTEC AG
Organization address contact info |
| Coordinator Country | Germany [DE] |
| Project website | http://www.impax.eu |
| Total cost | 3˙276˙387 € |
| EC max contribution | 2˙293˙471 € (70%) |
| Programme |
1. H2020-EU.2.1.5. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced manufacturing and processing) 2. H2020-EU.2.1.3. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Advanced materials) 3. H2020-EU.2.3.1. (Mainstreaming SME support, especially through a dedicated instrument) 4. H2020-EU.2.1.2. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Nanotechnologies) |
| Code Call | H2020-SMEINST-2-2016-2017 |
| Funding Scheme | SME-2 |
| Starting year | 2016 |
| Duration (year-month-day) | from 2016-09-01 to 2019-10-31 |
Partnership
Take a look of project's partnership.
| # | ||||
|---|---|---|---|---|
| 1 | COLVISTEC AG | DE (BERLIN) | coordinator | 2˙293˙471.00 |
Map
Project 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.
Deliverables
| Target of 10 events | Other | 2020-03-23 18:50:11 |
| Dissemination materials | Other | 2020-03-23 18:50:10 |
| Project website creation | Websites, patent fillings, videos etc. | 2019-05-30 15:21:34 |
Take a look to the deliverables list in detail: detailed list of IMPAX deliverables.
Publications
| year | authors and title | journal | last update |
|---|---|---|---|
| 2018 |
Wesholowski J, Berghaus A, Thommes M. Investigations Concerning the Residence Time Distribution of Twin-Screw-Extrusion Processes as Indicator for Inherent Mixing published pages: Issue 207, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics10040207 |
Pharmaceutics Oct 26;10(4) | 2020-02-05 |
| 2019 |
Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman and Walkiria Schlindwein Analytical Method Validation of in-line UV-Vis Spectroscopy for Hot Melt Extrusion Process published pages: , ISSN: , DOI: |
7th QbD Symposium, De Montfort University 7th March, 2019 | 2020-02-04 |
| 2019 |
Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein Development and Validation of an in-line API Quantification Method using AQbD Principles based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process published pages: In Press, ISSN: , DOI: |
Pharmaceutics In Press | 2020-02-04 |
| 2018 |
Walkiria Schlindwein, Mariana Bezerra, Juan Almeida, Andreas Berghaus, Martin Owen, Gordon Muirhead In-Line UV-Vis Spectroscopy as a Fast-Working Process Analytical Technology (PAT) during Early Phase Product Development Using Hot Melt Extrusion (HME) published pages: 166, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics10040166 |
Pharmaceutics 10/4 | 2020-02-04 |
| 2018 |
Abbe Haser, Brian Haight, Andreas Berghaus, Augie Machado, Charlie Martin, Feng Zhang Scale-Up and In-line Monitoring During Continuous Melt Extrusion of an Amorphous Solid Dispersion published pages: 2818-2827, ISSN: 1530-9932, DOI: 10.1208/s12249-018-1162-5 |
AAPS PharmSciTech 19/7 | 2020-02-04 |
| 2018 |
Jens Wesholowski, Andreas Berghaus, Markus Thommes Inline Determination of Residence Time Distribution in Hot-Melt-Extrusion published pages: 49, ISSN: 1999-4923, DOI: 10.3390/pharmaceutics10020049 |
Pharmaceutics 10/2 | 2020-02-04 |
| 2018 |
Wesholowski J, Berghaus A, Prill S, Thommes M. Inline UV/Vis spectroscopy as PAT tool for hot-melt extrusion published pages: 1595–1603, ISSN: 2190-3948, DOI: |
Drug Delivery and Translational Research January 2018; Volume 8 | 2020-02-04 |
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