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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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Outcomes and
results

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.

entire action optimization combination chain reduce pathophysiological primary batch operations separation reductions chromatography sensors centrifugation efficiency area improvements extremely dsp tangential successfully scope analytical consequently accessibility sequence environmental lowering flocculation manufacturing therapeutic elimination efficacy size footprint encompasses capture biopharmaceuticals replace despite drugs platform thereof protein tools substantial precipitation filtration cope limited volume sustainable technologies single patients continuous expand demands capturing derivatives efficient lower extensive alternative purifying 1982 insulin downstream monoclonal recombinant biosimilar significantly outcome utility moving water expensive bottleneck substitute first approved antibodies additionally disposable resin flow pat changing techniques

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 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.	SI (LJUBLJANA)	coordinator	2˙631˙737.00
2	MILLIPORE SAS MILLIPORE SAS Organization address address: 39 Route Industrielle de la Hardt city: Molsheim postcode: 67120 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.	FR (Molsheim)	participant	1˙700˙499.00
3	KARLSRUHER INSTITUT FUER TECHNOLOGIE KARLSRUHER INSTITUT FUER TECHNOLOGIE Organization address address: KAISERSTRASSE 12 city: KARLSRUHE postcode: 76131 website: www.kit.edu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (KARLSRUHE)	participant	1˙496˙625.00
4	UNIVERSITAET FUER BODENKULTUR WIEN UNIVERSITAET FUER BODENKULTUR WIEN Organization address address: GREGOR MENDEL STRASSE 33 city: WIEN postcode: 1180 website: www.boku.ac.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	1˙181˙063.00
5	KEMIJSKI INSTITUT KEMIJSKI INSTITUT Organization address address: HAJDRIHOVA 19 city: LJUBLJANA postcode: 1000 website: http://www.ki.si contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SI (LJUBLJANA)	participant	660˙375.00
6	NATIONAL SYSTEMS SRL NATIONAL SYSTEMS SRL Organization address address: VIA GOITO 60 city: SOMMA LOMBARDO VA postcode: 21019 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.	IT (SOMMA LOMBARDO VA)	participant	367˙657.00
7	SANDOZ GMBH SANDOZ GMBH Organization address address: Biochemiestraße 10 city: Kundl postcode: 6250 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.	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
Projectâ€™s end meeting with related agreements and final projectâ€™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 â€“ 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

List of publications.
year	authors and title	journal	last update
2018	Matic Grom, Mirijam Kozorog, Simon Caserman, Andrej Pohar, BlaÅ¾ 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, JÃ¼rgen 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, JÃ¼rgen 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 RÃ¼dt, Daniel BÃ¼chler, JÃ¼rgen 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 GroÃŸhans, Gang Wang, Christian Fischer, JÃ¼rgen 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 GroÃŸhans, Matthias RÃ¼dt, Adrian Sanden, Nina Brestrich, Josefine Morgenstern, Stefan Heissler,JÃ¼rgen 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, JÃ¼rgen 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 RÃ¼dt, Till Briskot, JÃ¼rgen Hubbuch Advances in downstream processing of biologics â€“ 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, JÃ¼rgen 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 RÃ¼dt, Sebastian Andris, Robin Schiemer, JÃ¼rgen 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 GroÃŸhans, Gang Wang, JÃ¼rgen 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 HofstÃ¤dter, 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 twoâ€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 Inâ€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 RÃ¼dt, Nina Brestrich, Laura Rolinger, JÃ¼rgen 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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