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nextBioPharmDSP

Next-generation biopharmaceutical downstream process

Total Cost €

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EC-Contrib. €

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Partnership

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 nextBioPharmDSP project word cloud

Explore the words cloud of the nextBioPharmDSP project. It provides you a very rough idea of what is the project "nextBioPharmDSP" about.

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Project "nextBioPharmDSP" data sheet

The following table provides information about the project.

Coordinator
LEK FARMACEVTSKA DRUZBA DD 

Organization address
address: VEROVSKOVA ULICA 57
city: LJUBLJANA
postcode: 1526
website: www.lek.si

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 Slovenia [SI]
 Project website http://www.nextbiopharmdsp.eu
 Total cost 10˙521˙448 €
 EC max contribution 8˙366˙432 € (80%)
 Programme 1. H2020-EU.2.1.4. (INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology)
 Code Call H2020-LEIT-BIO-2014-1
 Funding Scheme IA
 Starting year 2015
 Duration (year-month-day) from 2015-03-01   to  2019-02-28

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    LEK FARMACEVTSKA DRUZBA DD SI (LJUBLJANA) coordinator 2˙631˙737.00
2    MILLIPORE SAS FR (Molsheim) participant 1˙700˙499.00
3    KARLSRUHER INSTITUT FUER TECHNOLOGIE DE (KARLSRUHE) participant 1˙496˙625.00
4    UNIVERSITAET FUER BODENKULTUR WIEN AT (WIEN) participant 1˙181˙063.00
5    KEMIJSKI INSTITUT SI (LJUBLJANA) participant 660˙375.00
6    NATIONAL SYSTEMS SRL IT (SOMMA LOMBARDO VA) participant 367˙657.00
7    SANDOZ GMBH AT (Kundl) participant 328˙475.00

Map

 Project objective

The scope of the project is the optimization of downstream process (DSP) for the production of Biopharmaceuticals. Biopharmaceuticals have been successfully used as efficient therapeutic drugs for many pathophysiological conditions since the first recombinant product, insulin, was approved in 1982. Despite its efficacy, accessibility is still limited due to extremely high costs. In the production chain, capturing and purifying still represents a major bottleneck. Consequently, improvements in this area produce substantial cost reductions and expand patients’ accessibility to highly efficient drugs. Another aim of this action is to cope with the changing manufacturing demands, by lowering its environmental footprint and moving to more sustainable technologies. This proposal’s main objective is to implement a fully integrated manufacturing platform based on continuous chromatography in combination with disposable techniques for all unit operations of the DSP sequence for biosimilar monoclonal antibodies and derivatives thereof. The action encompasses the entire DSP sequence. We will implement alternative technologies for primary separation, such as flocculation or tangential flow filtration. The expected outcome is a reduction in the size and number of downstream unit operations and the elimination of centrifugation. Alternative approaches to the batch process for the capture step, such as continuous chromatography, will be evaluated in order to improve the efficiency and lower the need for expensive resin volume. Additionally precipitation utilization will be evaluated as an approach to replace protein A chromatography as capture step. A disposable continuous chromatography system will be developed together with novel analytical tools and sensors. Since single-use disposable systems can substitute the extensive use of resources (water) and significantly reduce the overall utility needs, the whole DSP sequence will be carried out on disposable technology (PAT).

 Deliverables

List of deliverables.
Layman report Documents, reports 2019-10-17 11:41:27
Report about the involvement in the international initiatives Documents, reports 2019-10-17 11:41:27
SWOT for final process Documents, reports 2019-10-17 11:41:26
Project’s end meeting with related agreements and final project’s conference in Ljubljana Documents, reports 2019-10-17 11:41:26
Newsletters and press release Documents, reports 2019-10-17 11:41:26
Stakeholder board completed and ready to receive updates (mailing list created) Websites, patent fillings, videos etc. 2019-10-17 11:41:26
Project Website updating Websites, patent fillings, videos etc. 2019-10-17 11:41:26
Workshops Websites, patent fillings, videos etc. 2019-10-17 11:41:26
Conferences (link on the website – event and paper presented) Websites, patent fillings, videos etc. 2019-10-17 11:41:26
P&ID (flow diagram) Other 2019-10-17 11:41:26
Scientific publications (link on the website after pre-review and possible embargo time) Documents, reports 2019-10-17 11:41:26
Definition of requirements for AAT Documents, reports 2019-10-17 11:41:26
Gender Language Control Websites, patent fillings, videos etc. 2019-10-17 11:41:26
Single-use flowpath definition and fit test on equipment Documents, reports 2019-10-17 11:41:26

Take a look to the deliverables list in detail:  detailed list of nextBioPharmDSP deliverables.

 Publications

year authors and title journal last update
List of publications.
2018 Matic Grom, Mirijam Kozorog, Simon Caserman, Andrej Pohar, Blaž Likozar
Protein A affinity chromatography of Chinese hamster ovary (CHO) cell culture broths containing biopharmaceutical monoclonal antibody (mAb): Experiments and mechanistic transport, binding and equilibrium modeling
published pages: 44-56, ISSN: 1570-0232, DOI: 10.1016/j.jchromb.2018.02.032
Journal of Chromatography B 1083 2019-10-17
2017 Gang Wang, Till Briskot, Tobias Hahn, Pascal Baumann, Jürgen Hubbuch
Root cause investigation of deviations in protein chromatography based on mechanistic models and artificial neural networks
published pages: 146-153, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2017.07.089
Journal of Chromatography A 1515 2019-10-17
2018 Peter Satzer, Alois Jungbauer
High-capacity protein A affinity chromatography for the fast quantification of antibodies: Two-wavelength detection expands linear range
published pages: , ISSN: 1615-9306, DOI: 10.1002/jssc.201701481
Journal of Separation Science 2019-10-17
2016 Gang Wang, Tobias Hahn, Jürgen Hubbuch
Water on hydrophobic surfaces: Mechanistic modeling of hydrophobic interaction chromatography
published pages: 71-78, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2016.07.085
Journal of Chromatography A Volume 1465 2019-10-17
2016 M. Carminati, M. Giacometti, M. Sampietro, S. Chiodini, T. Doles, G. Ferrari
Parallelizable Microfluidic Resistive On-Line Detector of Micrometric Aggregates of Biopharmaceutical Antibodies
published pages: 1438-1441, ISSN: 1877-7058, DOI: 10.1016/j.proeng.2016.11.410
Procedia Engineering 168 2019-10-17
2018 Nina Brestrich, Matthias Rüdt, Daniel Büchler, Jürgen Hubbuch
Selective protein quantification for preparative chromatography using variable pathlength UV/Vis spectroscopy and partial least squares regression
published pages: 157-164, ISSN: 0009-2509, DOI: 10.1016/j.ces.2017.10.030
Chemical Engineering Science 176 2019-10-17
2018 Steffen Großhans, Gang Wang, Christian Fischer, Jürgen Hubbuch
An integrated precipitation and ion-exchange chromatography process for antibody manufacturing: Process development strategy and continuous chromatography exploration
published pages: 66-76, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2017.12.013
Journal of Chromatography A 1533 2019-10-17
2018 Steffen Großhans, Matthias Rüdt, Adrian Sanden, Nina Brestrich, Josefine Morgenstern, Stefan Heissler,Jürgen Hubbuch
In-line Fourier-transform infrared spectroscopy as a versatile process analytical technology for preparative protein chromatography
published pages: 37-44, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2018.03.005
Journal of Chromatography A 1547 2019-10-17
2017 Gang Wang, Till Briskot, Tobias Hahn, Pascal Baumann, Jürgen Hubbuch
Estimation of adsorption isotherm and mass transfer parameters in protein chromatography using artificial neural networks
published pages: 211-217, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2017.01.068
Journal of Chromatography A 1487 2019-10-17
2017 Matthias Rüdt, Till Briskot, Jürgen Hubbuch
Advances in downstream processing of biologics – Spectroscopy: An emerging process analytical technology
published pages: 2-9, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2016.11.010
Journal of Chromatography A 1490 2019-10-17
2017 Josefine Morgenstern, Gang Wang, Pascal Baumann, Jürgen Hubbuch
Model-Based Investigation on the Mass Transfer and Adsorption Mechanisms of Mono-Pegylated Lysozyme in Ion-Exchange Chromatography
published pages: 1700255, ISSN: 1860-6768, DOI: 10.1002/biot.201700255
Biotechnology Journal 12/9 2019-10-17
2019 Matthias Rüdt, Sebastian Andris, Robin Schiemer, Jürgen Hubbuch
Factorization of preparative protein chromatograms with hard-constraint multivariate curve resolution and second-derivative pretreatment
published pages: 152-160, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2018.11.065
Journal of Chromatography A 1585 2019-10-17
2019 Steffen Großhans, Gang Wang, Jürgen Hubbuch
Water on hydrophobic surfaces: mechanistic modeling of polyethylene glycol-induced protein precipitation
published pages: 513-520, ISSN: 1615-7591, DOI: 10.1007/s00449-018-2054-5
Bioprocess and Biosystems Engineering 42/4 2019-10-17
2018 Peter Satzer, Ralf Sommer, Johanna Paulsson, Agnes Rodler, Romana Zehetner, Klaus Hofstädter, Christoph Klade, Alois Jungbauer
Monolith affinity chromatography for the rapid quantification of a single-chain variable fragment immunotoxin
published pages: 3051-3059, ISSN: 1615-9306, DOI: 10.1002/jssc.201800257
Journal of Separation Science 41/15 2019-10-17
2018 Walpurga Krepper, Peter Satzer, Beate Maria Beyer, Alois Jungbauer
Temperature dependence of antibody adsorption in protein A affinity chromatography
published pages: 59-68, ISSN: 0021-9673, DOI: 10.1016/j.chroma.2018.03.059
Journal of Chromatography A 1551 2019-10-17
2019 Daniel Burgstaller, Alois Jungbauer, Peter Satzer
Continuous integrated antibody precipitation with two‐stage tangential flow microfiltration enables constant mass flow
published pages: , ISSN: 0006-3592, DOI: 10.1002/bit.26922
Biotechnology and Bioengineering 2019-10-17
2018 Christopher Gillespie, Melissa Holstein, Lori Mullin, Kristen Cotoni, Ronald Tuccelli, John Caulmare, Patricia Greenhalgh
Continuous In‐Line Virus Inactivation for Next Generation Bioprocessing
published pages: 1700718, ISSN: 1860-6768, DOI: 10.1002/biot.201700718
Biotechnology Journal 14/2 2019-10-17
2016 Matthias Rüdt, Nina Brestrich, Laura Rolinger, Jürgen Hubbuch
Real-time monitoring and control of the load phase of a protein A capture step
published pages: 6, ISSN: 0006-3592, DOI: 10.1002/bit.26078
Biotechnology and Bioengineering 2019-10-17

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