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IMPAX SIGNED

Inline/Instant Measurement for PhArma eXtrusion

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

IMPAX 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.

first age automation trend faces soluble form implies colvistec extruder solution alternatively fulfilment continuous benefit shown rely university pharmacological basf endcap shift spectroscopy poorly bioavailability stakeholders abbvie uv fda manufacturing poor fcnw wet granulation adopting environment drugs nir digitalisation impax lower spectra raman reutlingen disinvestment boosting techniques regulations competition compliant usa companies efficiency drug melt catalent cm batch markets facilities competitive initial biological undertaken proper extrusion molecules hot investment technologies vis platform extend mean software industry innovative contract principles active manufacturers pharma time inflexibility ema safety monitoring universities combine analytical extensive market most pat written incorporate

Project "IMPAX" data sheet

The following table provides information about the project.

Coordinator	COLVISTEC AG Organization address address: MAX-PLANCK-STRASSE 3 city: BERLIN postcode: 12489 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
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.

#	participants	country	role	EC contrib. [€]
1	COLVISTEC AG COLVISTEC AG Organization address address: MAX-PLANCK-STRASSE 3 city: BERLIN postcode: 12489 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	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

List of 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

List of 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: 1595â€“1603, ISSN: 2190-3948, DOI:	Drug Delivery and Translational Research January 2018; Volume 8	2020-02-04

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The information about "IMPAX" are provided by the European Opendata Portal: CORDIS opendata.