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CORDIS - Risultati della ricerca dell’UE
CORDIS

Protein-excipient Interactions and Protein-Protein Interactions in formulation

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Society outreach including scientific publications (si apre in una nuova finestra)

Publication results in Scientific journals and at international conferences and workshops. Easy-to-read information material for the society at large.

Aggregation propensity assessed for all proteins (si apre in una nuova finestra)

Aggregation propensity - including surface induced aggregation propensity - assessed for all proteins.

Weak and strong protein-protein and protein-excipient interactions are identified. (si apre in una nuova finestra)

For all proteins in the library the relevant weak and strong protein-protein and protein-excipient interactions are identified.

Structures based on measurements and modeling (si apre in una nuova finestra)

For all soluble proteins, there will be at least 1 but preferable 2 or more solution structures based on SAXS measurements and in-silico modeling

Tagg and Tgel are determined for each protein (si apre in una nuova finestra)

For each protein the determination of the temperature of aggregation, Tagg, and gelation, Tgel, using light scattering experiments, differential scanning calorimetry and temperature ramp rheology Measurements.

Protocols for the making of screens 1 and 2 established (si apre in una nuova finestra)

A general protocol for the making of the screens 1 and 2 that are used for all proteins should be ready

International conference (si apre in una nuova finestra)

International conferences with contribution from all ESRs as well as external contributions.

Model for the prediction of protein aggregation and stability (si apre in una nuova finestra)

A general model for the prediction of protein aggregation and stability of all proteins

Database made public accessible (si apre in una nuova finestra)

Database with web-based graphical interface will be made public accessible

Project website (si apre in una nuova finestra)

Establishment of a PIPPI website with a password protected area and a publically accessible area.

Personal Carrier Development Plans (si apre in una nuova finestra)

For all ESRs a personal carrier Development plan will be ready.

Periodic, financial and final reports to the EC (si apre in una nuova finestra)

Reports will be delivered to the EC periodically. This covers also the Financial reports. A report will be given in when the project finishes.

Evaluation report on training activities (si apre in una nuova finestra)

For all training activities an evaluation report will be ready

Pubblicazioni

Binding of excipients is a poor predictor for aggregation kinetics of biopharmaceutical proteins (si apre in una nuova finestra)

Autori: Matja Zalar, Hristo Svilenov, Alexander Golovanov
Pubblicato in: European Journal of Pharmaceutics and Biopharmaceutics, 2020, Pagina/e 127-136, ISSN 0939-6411
Editore: Elsevier BV
DOI: 10.1016/j.ejpb.2020.04.002

The Effect of Point Mutations on the Biophysical Properties of an Antimicrobial Peptide: Development of a Screening Protocol for Peptide Stability Screening (si apre in una nuova finestra)

Autori: Christin Pohl, Matja Zalar, Inas El Bialy, Sowmya Indrakumar, Günther H. J. Peters, Wolfgang Friess, Alexander P. Golovanov, Werner W. Streicher, Allan Noergaard, and Pernille Harris
Pubblicato in: Molecular Pharmaceutics, 2020, ISSN 1543-8384
Editore: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.0c00406

Self-Interactions of Two Monoclonal Antibodies: Small-Angle X-ray Scattering, Light Scattering, and Coarse-Grained Modeling (si apre in una nuova finestra)

Autori: Sujata Mahapatra, Marco Polimeni, Lorenzo Gentiluomo , Dierk Roessner , Wolfgang Frieß , Günther H J Peters , Werner W Streicher , Mikael Lund , Pernille Harris
Pubblicato in: Molecular Pharmaceutics, 2022, ISSN 1543-8384
Editore: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.1c00627

Application of machine learning to predict monomer retention of therapeutic proteins after long term storage (si apre in una nuova finestra)

Autori: Lorenzo Gentiluomo; Dierk Roessner, Wolfgan Frieß
Pubblicato in: International Journal of Pharmaceutics, 2020, ISSN 0378-5173
Editore: Elsevier BV
DOI: 10.1016/j.ijpharm.2020.119039

Towards an improved prediction of concentrated antibody solution viscosity using the Huggins coefficient (si apre in una nuova finestra)

Autori: Roche, A., Gentiluomo, L., Sibanda, N., Roessner, D., Friess, W., Trainoff, S. P., & Curtis, R.
Pubblicato in: Journal of Colloid and Interface Science, 2022, ISSN 0021-9797
Editore: Academic Press
DOI: 10.1016/j.jcis.2021.08.191

Isothermal chemical denaturation as a complementary tool to overcome limitations of thermal differential scanning fluorimetry in predicting physical stability of protein formulations (si apre in una nuova finestra)

Autori: Hristo Svilenov, Uroš Markoja, Gerhard Winter
Pubblicato in: European Journal of Pharmaceutics and Biopharmaceutics, Numero 125, 2018, Pagina/e 106-113, ISSN 0939-6411
Editore: Elsevier BV
DOI: 10.1016/j.ejpb.2018.01.004

A New Approach to Study the Physical Stability of Monoclonal Antibody Formulations—Dilution From a Denaturant (si apre in una nuova finestra)

Autori: Hristo Svilenov, Lorenzo Gentiluomo, Wolfgang Friess, Dierk Roessner, Gerhard Winter
Pubblicato in: Journal of Pharmaceutical Sciences, Numero 107/12, 2018, Pagina/e 3007-3013, ISSN 0022-3549
Editore: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2018.08.004

New Disulphide Bond in Cystatin-Based Protein Scaffold Prevents Domain-Swap-Mediated Oligomerization and Stabilizes the Functionally Active Form (si apre in una nuova finestra)

Autori: Matja Zalar, Alexander P. Golovanov
Pubblicato in: ACS Omega, Numero 4/19, 2019, Pagina/e 18248-18256, ISSN 2470-1343
Editore: Americal Chemical Society
DOI: 10.1021/acsomega.9b02269

Total Description of Intrinsic Amphiphile Aggregation: Calorimetry Study and Molecular Probing (si apre in una nuova finestra)

Autori: Roberto Fernandez-Alvarez, Žiga Medoš, Zdeněk Tošner, Alexander Zhigunov, Mariusz Uchman, Stefan Hervø-Hansen, Mikael Lund, Marija Bešter-Rogač, Pavel Matějíček
Pubblicato in: Langmuir, Numero 34/47, 2018, Pagina/e 14448-14457, ISSN 0743-7463
Editore: American Chemical Society
DOI: 10.1021/acs.langmuir.8b03462

Conformational Stability Study of a Therapeutic Peptide Plectasin Using Molecular Dynamics Simulations in Combination with NMR (si apre in una nuova finestra)

Autori: Sowmya Indrakumar, Matja Zalar, Christin Pohl, Allan Nørgaard, Werner Streicher, Pernille Harris, Alexander P. Golovanov, Günther H.J. Peters
Pubblicato in: The Journal of Physical Chemistry B, Numero 123/23, 2019, Pagina/e 4867-4877, ISSN 1520-6106
Editore: American Chemical Society
DOI: 10.1021/acs.jpcb.9b02370

Studies of the oligomerisation mechanism of a cystatin-based engineered protein scaffold (si apre in una nuova finestra)

Autori: Matja Zalar, Sowmya Indrakumar, Colin W. Levy, Richard B. Tunnicliffe, Günther H. J. Peters, Alexander P. Golovanov
Pubblicato in: Scientific Reports, Numero 9/1, 2019, ISSN 2045-2322
Editore: Nature Publishing Group
DOI: 10.1038/s41598-019-45565-6

Novel non-linear curve fitting to resolve protein unfolding transitions in intrinsic fluorescence differential scanning fluorimetry (si apre in una nuova finestra)

Autori: Dillen Augustijn, Sujata Mahapatra, Werner Streicher, Hristo Svilenov, Alina Kulakova, Christin Pohl, Åsmund Rinnan
Pubblicato in: European Journal of Pharmaceutics and Biopharmaceutics, Numero 142, 2019, Pagina/e 506-517, ISSN 0939-6411
Editore: Elsevier BV
DOI: 10.1016/j.ejpb.2019.06.001

Interaction of a Macrocycle with an Aggregation-Prone Region of a Monoclonal Antibody (si apre in una nuova finestra)

Autori: Marcello Martinez Morales, Matja Zalar, Silvia Sonzini, Alexander P. Golovanov, Christopher F. van der Walle, Jeremy P. Derrick
Pubblicato in: Molecular Pharmaceutics, Numero 16/7, 2019, Pagina/e 3100-3108, ISSN 1543-8384
Editore: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.9b00338

The ReFOLD assay for protein formulation studies and prediction of protein aggregation during long-term storage (si apre in una nuova finestra)

Autori: Hristo Svilenov, Gerhard Winter
Pubblicato in: European Journal of Pharmaceutics and Biopharmaceutics, Numero 137, 2019, Pagina/e 131-139, ISSN 0939-6411
Editore: Elsevier BV
DOI: 10.1016/j.ejpb.2019.02.018

Improved Physical Stability of an Antibody–Drug Conjugate Using Host–Guest Chemistry (si apre in una nuova finestra)

Autori: Silvia Sonzini, Maria Laura Greco, Thais Cailleau, Lauren Adams, Luke Masterson, Balakumar Vijayakrishnan, Conor Barry, Phillip Howard, Peter Ravn, Christopher F. van der Walle
Pubblicato in: Bioconjugate Chemistry, 2019, ISSN 1043-1802
Editore: American Chemical Society
DOI: 10.1021/acs.bioconjchem.9b00809

Rapid sample-saving biophysical characterisation and long-term storage stability of liquid interferon alpha2a formulations: Is there a correlation? (si apre in una nuova finestra)

Autori: Hristo Svilenov, Gerhard Winter
Pubblicato in: International Journal of Pharmaceutics, Numero 562, 2019, Pagina/e 42-50, ISSN 0378-5173
Editore: Elsevier BV
DOI: 10.1016/j.ijpharm.2019.03.025

Coupling Multi-Angle Light Scattering to Reverse-Phase Ultra-High-Pressure Chromatography (RP-UPLC-MALS) for the characterization monoclonal antibodies (si apre in una nuova finestra)

Autori: Lorenzo Gentiluomo, Vanessa Schneider, Dierk Roessner, Wolfgang Frieß
Pubblicato in: Scientific Reports, Numero 9/1, 2019, ISSN 2045-2322
Editore: Nature Publishing Group
DOI: 10.1038/s41598-019-51233-6

Exploring Chemical Space for New Substances to Stabilize a Therapeutic Monoclonal Antibody (si apre in una nuova finestra)

Autori: Andreas Tosstorff, Tim Menzen, Gerhard Winter
Pubblicato in: Journal of Pharmaceutical Sciences, Numero 109/1, 2020, Pagina/e 301-307, ISSN 0022-3549
Editore: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2019.10.057

Small angle X-ray scattering and molecular dynamic simulations provide molecular insight for stability of recombinant human transferrin (si apre in una nuova finestra)

Autori: Alina Kulakova, Sowmya Indrakumar, Pernille Sønderby, Lorenzo Gentiluomo, Werner Streicher, Dierk Roessner, Wolfgang Frieß, Günther H.J. Peters, Pernille Harris
Pubblicato in: Journal of Structural Biology: X, Numero 4, 2020, Pagina/e 100017, ISSN 2590-1524
Editore: Elsevier
DOI: 10.1016/j.yjsbx.2019.100017

Advancing Therapeutic Protein Discovery and Development through Comprehensive Computational and Biophysical Characterization (si apre in una nuova finestra)

Autori: Lorenzo Gentiluomo, Hristo L. Svilenov, Dillen Augustijn, Inas El Bialy, Maria Laura Greco, Alina Kulakova, Sowmya Indrakumar, Sujata Mahapatra, Marcello Martinez Morales, Christin Pohl, Aisling Roche, Andreas Tosstorff, Robin Curtis, Jeremy P. Derrick, Allan Nørgaard, Tarik A. Khan, Günther H. J. Peters, Alain Pluen, Åsmund Rinnan, Werner W. Streicher, Christopher F. van der Walle, Shahid Uddi
Pubblicato in: Molecular Pharmaceutics, 2020, ISSN 1543-8384
Editore: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.9b00852

Models for Antibody Behavior in Hydrophobic Interaction Chromatography and in Self-Association (si apre in una nuova finestra)

Autori: Max Hebditch, Aisling Roche, Robin A. Curtis, Jim Warwicker
Pubblicato in: Journal of Pharmaceutical Sciences, Numero 108/4, 2019, Pagina/e 1434-1441, ISSN 0022-3549
Editore: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2018.11.035

Characterization of Native Reversible Self-Association of a Monoclonal Antibody Mediated by Fab-Fab Interaction (si apre in una nuova finestra)

Autori: Lorenzo Gentiluomo, Dierk Roessner, Werner Streicher, Sujata Mahapatra, Pernille Harris, Wolfgang Frieß
Pubblicato in: Journal of Pharmaceutical Sciences, Numero 109/1, 2020, Pagina/e 443-451, ISSN 0022-3549
Editore: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2019.09.021

Application of interpretable artificial neural networks to early monoclonal antibodies development (si apre in una nuova finestra)

Autori: Lorenzo Gentiluomo, Dierk Roessner, Dillen Augustijn, Hristo Svilenov, Alina Kulakova, Sujata Mahapatra, Gerhard Winter, Werner Streicher, Åsmund Rinnan, Günther H.J. Peters, Pernille Harris, Wolfgang Frieß
Pubblicato in: European Journal of Pharmaceutics and Biopharmaceutics, Numero 141, 2019, Pagina/e 81-89, ISSN 0939-6411
Editore: Elsevier BV
DOI: 10.1016/j.ejpb.2019.05.017

Orthogonal Techniques to Study the Effect of pH, Sucrose, and Arginine Salts on Monoclonal Antibody Physical Stability and Aggregation During Long-Term Storage (si apre in una nuova finestra)

Autori: Hristo L. Svilenov, Alina Kulakova, Matja Zalar, Alexander P. Golovanov, Pernille Harris, Gerhard Winter
Pubblicato in: Journal of Pharmaceutical Sciences, Numero 109/1, 2020, Pagina/e 584-594, ISSN 0022-3549
Editore: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2019.10.065

Structure-based discovery of a new protein-aggregation breaking excipient (si apre in una nuova finestra)

Autori: Andreas Tosstorff, Hristo Svilenov, Günther H.J. Peters, Pernille Harris, Gerhard Winter
Pubblicato in: European Journal of Pharmaceutics and Biopharmaceutics, Numero 144, 2019, Pagina/e 207-216, ISSN 0939-6411
Editore: Elsevier BV
DOI: 10.1016/j.ejpb.2019.09.010

Determination of Protein–Protein Interactions in a Mixture of Two Monoclonal Antibodies (si apre in una nuova finestra)

Autori: Priyanka Singh, Aisling Roche, Christopher F. van der Walle, Shahid Uddin, Jiali Du, Jim Warwicker, Alain Pluen, Robin Curtis
Pubblicato in: Molecular Pharmaceutics, Numero 16/12, 2019, Pagina/e 4775-4786, ISSN 1543-8384
Editore: American Chemical Society
DOI: 10.1021/acs.molpharmaceut.9b00430

Modulated_Scanning_Fluorimetry_Can_Quickly_Assess_Thermal_Protein_Unfolding_Reversibility_in_Microvolume_Samples (si apre in una nuova finestra)

Autori: Hristo Svilenov, Tim Menzen, Klaus Richter, Gerhard Winter
Pubblicato in: Molecular Pharmaceutics, 2020, Pagina/e 2638-2647, ISSN 1543-8392
Editore: American Chemical Association
DOI: 10.1021/acs.molpharmaceut.0c00330

PIPPI – Protein-excipient Interactions and Protein-Protein Interactions in formulation – ERC (si apre in una nuova finestra)

Autori: Pernille Harris
Pubblicato in: Impact, Numero 2017/8, 2017, Pagina/e 75-77, ISSN 2398-7073
Editore: Science Impact Ltd
DOI: 10.21820/23987073.2017.8.75

Structural-stability studies on recombinant human transferrin (si apre in una nuova finestra)

Autori: A. Kulakova, S. Indrakumar, P. Sønderby, L. Gentiluomo, W. Streicher, D. Roessner, W. Frieß, G. H.J. Peters, P. Harris
Pubblicato in: bioRxiv, 2019
Editore: Cold Spring Harbor Laborator
DOI: 10.1101/742957

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