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IMPAX SIGNED

Inline/Instant Measurement for PhArma eXtrusion

Total Cost €

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EC-Contrib. €

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Partnership

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 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 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

year authors and title journal last update
List of publications.
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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The information about "IMPAX" are provided by the European Opendata Portal: CORDIS opendata.

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