Next-generation biopharmaceutical downstream process

Deliverables

Detailed definition and description of requirements (detailed definition of requirements, evaluation of available tools).

SWOT for final process

Assessment of next-generation DSP process (SWOT analysis, Cost & environmental impact assessment (COG, CAPEX, OPEX), LCA). Evaluation of further possible improvements.

Project’s end meeting with related agreements and final project’s conference in Ljubljana

In order to conclude the consortium Agreement, many different legal documents will be signed during the last consortium meeting. All the documents will be collected and stored for 5 years by LEK.

Single-use flowpath definition and fit test on equipment

Definition of single-use assemblies, assemblies drawings and fit test on equipment.

Scientific publications (link on the website after pre-review and possible embargo time)

The scientific papers connected to the project activities will be made available (after the innovation manager review and magazine pre-review and possible embargo time) through a a direct link that will be pubblished on the project web-site.

Newsletters and press release

Preparing and sending newsletters (different contents for each type of stakeholder) about the specific developments of the project. due date every 6 months

Report about the involvement in the international initiatives

As part of dissemination plan we have included the participation to two main international initiatives: 1: MIT-Novartis continuous manufacturing consortium; 2.Continuous Manufacturing and Crystallisation [CMAC]. Before the end of the project we will deliver a report with the results connected to these initiative and the project benefits derived from this involvement.

Layman report

A description of the overall completed project , the procees optimised and the benefits that it will provide will be organised in a magazin-like document, explained in a non technical langauge, and spread among the regulatory agencies, stakeholder and media.

Workshops

A report of the presentation at specialised wotrkshops (that have been identified by each partner in the DoA) will be gathered in one report that will be part of the progress (and financial report).Months, 18 - 36 - 48

Conferences (link on the website – event and paper presented)

A report of the presentation at specialised conferences (that have been identified by each partner in the DoA) will be gathered in one report that will be part of the progress (and financial report).Months, 18 - 36 - 48

Stakeholder board completed and ready to receive updates (mailing list created)

A detailed list of stakeholder (related to the project innovation and to all connected results) will be created, and a communication strategy will be implemented. These organisation will receive our updates on a regualar basis (please refer to the deliverable 8.7). Of utmost importance are the National Regulatory Agencies, the European Medicine Agency and the Food and Drug Administration)

Gender Language Control

A report about the gender mitigation measures undertaken by the consortium in every phase of the dissemination and management will be edited and delivered to the EC in the Progress and financial reports. Due date: 18-38 - 48

Project Website updating

The Project website is updated with the project developments on a regular basis (once per month after the website is available).

P&ID (flow diagram)

P&ID (flow diagram) for continuous chromatography disposable equipment.

Publications

High-capacity protein A affinity chromatography for the fast quantification of antibodies: Two-wavelength detection expands linear range

Author(s): Peter Satzer, Alois Jungbauer
Published in: Journal of Separation Science, 2018, ISSN 1615-9306
Publisher: John Wiley & Sons Ltd.
DOI: 10.1002/jssc.201701481

Continuous cell flocculation for recombinant antibody harvesting

Author(s): Daniel Burgstaller, Walpurga Krepper, Josselyn Haas, Marine Maszelin, Jure Mohoric, Katja Pajnic, Alois Jungbauer, Peter Satzer
Published in: Journal of Chemical Technology & Biotechnology, 2017, ISSN 0268-2575
Publisher: John Wiley & Sons Inc.
DOI: 10.1002/jctb.5500

Advances in downstream processing of biologics – Spectroscopy: An emerging process analytical technology

Author(s): Matthias Rüdt, Till Briskot, Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue 1490, 2017, Page(s) 2-9, ISSN 0021-9673
Publisher: Elsevier
DOI: 10.1016/j.chroma.2016.11.010

Estimation of adsorption isotherm and mass transfer parameters in protein chromatography using artificial neural networks

Author(s): Gang Wang, Till Briskot, Tobias Hahn, Pascal Baumann, Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue 1487, 2017, Page(s) 211-217, ISSN 0021-9673
Publisher: Elsevier
DOI: 10.1016/j.chroma.2017.01.068

Root cause investigation of deviations in protein chromatography based on mechanistic models and artificial neural networks

Author(s): Gang Wang, Till Briskot, Tobias Hahn, Pascal Baumann, Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue 1515, 2017, Page(s) 146-153, ISSN 0021-9673
Publisher: Elsevier
DOI: 10.1016/j.chroma.2017.07.089

An integrated precipitation and ion-exchange chromatography process for antibody manufacturing: Process development strategy and continuous chromatography exploration

Author(s): Steffen Großhans, Gang Wang, Christian Fischer, Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue 1533, 2018, Page(s) 66-76, ISSN 0021-9673
Publisher: Elsevier
DOI: 10.1016/j.chroma.2017.12.013

Selective protein quantification for preparative chromatography using variable pathlength UV/Vis spectroscopy and partial least squares regression

Author(s): Nina Brestrich, Matthias Rüdt, Daniel Büchler, Jürgen Hubbuch
Published in: Chemical Engineering Science, Issue 176, 2018, Page(s) 157-164, ISSN 0009-2509
Publisher: Pergamon Press Ltd.
DOI: 10.1016/j.ces.2017.10.030

In-line Fourier-transform infrared spectroscopy as a versatile process analytical technology for preparative protein chromatography

Author(s): Steffen Großhans, Matthias Rüdt, Adrian Sanden, Nina Brestrich, Josefine Morgenstern, Stefan Heissler,Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue 1547, 2018, Page(s) 37-44, ISSN 0021-9673
Publisher: Elsevier
DOI: 10.1016/j.chroma.2018.03.005

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

Author(s): Matic Grom, Mirijam Kozorog, Simon Caserman, Andrej Pohar, Blaž Likozar
Published in: Journal of Chromatography B, Issue 1083, 2018, Page(s) 44-56, ISSN 1570-0232
Publisher: Elsevier BV
DOI: 10.1016/j.jchromb.2018.02.032

Water on hydrophobic surfaces: Mechanistic modeling of hydrophobic interaction chromatography

Author(s): Gang Wang, Tobias Hahn, Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue Volume 1465, 2016, Page(s) 71-78, ISSN 0021-9673
Publisher: Elsevier B.V.
DOI: 10.1016/j.chroma.2016.07.085

Model-Based Investigation on the Mass Transfer and Adsorption Mechanisms of Mono-Pegylated Lysozyme in Ion-Exchange Chromatography

Author(s): Josefine Morgenstern, Gang Wang, Pascal Baumann, Jürgen Hubbuch
Published in: Biotechnology Journal, Issue 12/9, 2017, Page(s) 1700255, ISSN 1860-6768
Publisher: Wiley - VCH Verlag GmbH & CO. KGaA
DOI: 10.1002/biot.201700255

Parallelizable Microfluidic Resistive On-Line Detector of Micrometric Aggregates of Biopharmaceutical Antibodies

Author(s): M. Carminati, M. Giacometti, M. Sampietro, S. Chiodini, T. Doles, G. Ferrari
Published in: Procedia Engineering, Issue 168, 2016, Page(s) 1438-1441, ISSN 1877-7058
Publisher: Proceedings of the 30th anniversary Eurosensors Conference – Eurosensors 2016
DOI: 10.1016/j.proeng.2016.11.410

Real-time monitoring and control of the load phase of a protein A capture step

Author(s): Matthias Rüdt, Nina Brestrich, Laura Rolinger, Jürgen Hubbuch
Published in: Biotechnology and Bioengineering, 2016, Page(s) 6, ISSN 0006-3592
Publisher: Wiley - V C H Verlag GmbbH & Co.
DOI: 10.1002/bit.26078

Continuous integrated antibody precipitation with two‐stage tangential flow microfiltration enables constant mass flow

Author(s): Daniel Burgstaller, Alois Jungbauer, Peter Satzer
Published in: Biotechnology and Bioengineering, 2019, ISSN 0006-3592
Publisher: Wiley - V C H Verlag GmbbH & Co.
DOI: 10.1002/bit.26922

Temperature dependence of antibody adsorption in protein A affinity chromatography

Author(s): Walpurga Krepper, Peter Satzer, Beate Maria Beyer, Alois Jungbauer
Published in: Journal of Chromatography A, Issue 1551, 2018, Page(s) 59-68, ISSN 0021-9673
Publisher: Elsevier BV
DOI: 10.1016/j.chroma.2018.03.059

Monolith affinity chromatography for the rapid quantification of a single-chain variable fragment immunotoxin

Author(s): Peter Satzer, Ralf Sommer, Johanna Paulsson, Agnes Rodler, Romana Zehetner, Klaus Hofstädter, Christoph Klade, Alois Jungbauer
Published in: Journal of Separation Science, Issue 41/15, 2018, Page(s) 3051-3059, ISSN 1615-9306
Publisher: John Wiley & Sons Ltd.
DOI: 10.1002/jssc.201800257

Continuous In‐Line Virus Inactivation for Next Generation Bioprocessing

Author(s): Christopher Gillespie, Melissa Holstein, Lori Mullin, Kristen Cotoni, Ronald Tuccelli, John Caulmare, Patricia Greenhalgh
Published in: Biotechnology Journal, Issue 14/2, 2018, Page(s) 1700718, ISSN 1860-6768
Publisher: Wiley - VCH Verlag GmbH & CO. KGaA
DOI: 10.1002/biot.201700718

Factorization of preparative protein chromatograms with hard-constraint multivariate curve resolution and second-derivative pretreatment

Author(s): Matthias Rüdt, Sebastian Andris, Robin Schiemer, Jürgen Hubbuch
Published in: Journal of Chromatography A, Issue 1585, 2019, Page(s) 152-160, ISSN 0021-9673
Publisher: Elsevier BV
DOI: 10.1016/j.chroma.2018.11.065

Water on hydrophobic surfaces: mechanistic modeling of polyethylene glycol-induced protein precipitation

Author(s): Steffen Großhans, Gang Wang, Jürgen Hubbuch
Published in: Bioprocess and Biosystems Engineering, Issue 42/4, 2019, Page(s) 513-520, ISSN 1615-7591
Publisher: Springer Verlag
DOI: 10.1007/s00449-018-2054-5

Intellectual Property Rights

Device and method for detecting nonelectrolyte particles in two flows of liquid solutions containing an electrolyte

Application/Publication number: WO 2017187252A1
Date: 2017-11-02
Applicant(s): NATIONAL SYSTEMS SRL

Deliverables

Publications

Intellectual Property Rights

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