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Protein-excipient Interactions and Protein-Protein Interactions in formulation

Total Cost €


EC-Contrib. €






Project "PIPPI" data sheet

The following table provides information about the project.


Organization address
postcode: 2800

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 Denmark [DK]
 Project website
 Total cost 4˙067˙745 €
 EC max contribution 4˙067˙745 € (100%)
 Programme 1. H2020-EU.1.3.1. (Fostering new skills by means of excellent initial training of researchers)
 Code Call H2020-MSCA-ITN-2015
 Funding Scheme MSCA-ITN-ETN
 Starting year 2016
 Duration (year-month-day) from 2016-01-01   to  2019-12-31


Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
3    NOVOZYMES A/S DK (BAGSVAERD) participant 580˙163.00
4    MEDIMMUNE LIMITED UK (CAMBRIDGE) participant 546˙575.00
6    LUNDS UNIVERSITET SE (LUND) participant 527˙318.00
7    KOBENHAVNS UNIVERSITET DK (KOBENHAVN) participant 290˙081.00
8    WYATT TECHNOLOGY EUROPE GMBH DE (Dernbach) participant 249˙216.00
9    LUNDS UNIVERSITET SE (Lund) partner 0.00


 Project objective

The revolution of biotechnology has led to the creation of various types of therapeutic biologics with the potential to provide treatment for new chronic and malignant diseases. Though the potential advantages of biologics lay in their high specificity and potency combined with few side effects, their formulation still remains a large challenge to pharmaceutical scientists. This is in part due to the complex, not-well understood relationship between the physicochemical properties of proteins and formulation conditions required for protein stability. A comprehensive understanding of the molecular mechanisms behind protein stabilization and solubility would provide the formulation scientists with knowledge of the interplay between formulation and stability that in turn could potentially make formulation development faster, cheaper and less labour intensive than the currently used broad screening approach. Understanding the susceptibilities of formulations to protein aggregation and denaturation can reduce the response time to for instance product failure. Few universities in Europe have formulation of biologics as a scientific subject. Consequently, the pharmaceutical industry is forced to train scientists - a challenge for larger companies, and an insurmountable task for smaller companies. Scientists in the field of structural biology, biophysics, protein formulation and stability have formed a consortium to systematically map physicochemical properties of biologics, formulation conditions and protein stability. The main objective of the consortium is to provide a new generation of innovative and entrepreneurial early-stage researchers that will develop methodologies, tools and databases to guide the formulation of robust biologics. The consortium will not only provide an excellent platform to train a new generation of formulation scientists, but also establish avenues for designing new formulation strategies and thereby securing the leading edge of EU expertise.


List of deliverables.
Project website Websites, patent fillings, videos etc. 2019-05-31 18:15:21

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


year authors and title journal last update
List of publications.
2019 Priyanka Singh, Aisling Roche, Christopher F. van der Walle, Shahid Uddin, Jiali Du, Jim Warwicker, Alain Pluen, Robin Curtis
Determination of Protein–Protein Interactions in a Mixture of Two Monoclonal Antibodies
published pages: 4775-4786, ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.9b00430
Molecular Pharmaceutics 16/12 2020-02-13
2019 Max Hebditch, Aisling Roche, Robin A. Curtis, Jim Warwicker
Models for Antibody Behavior in Hydrophobic Interaction Chromatography and in Self-Association
published pages: 1434-1441, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2018.11.035
Journal of Pharmaceutical Sciences 108/4 2020-01-30
2019 Matja Zalar, Alexander P. Golovanov
New Disulphide Bond in Cystatin-Based Protein Scaffold Prevents Domain-Swap-Mediated Oligomerization and Stabilizes the Functionally Active Form
published pages: 18248-18256, ISSN: 2470-1343, DOI: 10.1021/acsomega.9b02269
ACS Omega 4/19 2020-01-30
2019 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
Application of interpretable artificial neural networks to early monoclonal antibodies development
published pages: 81-89, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2019.05.017
European Journal of Pharmaceutics and Biopharmaceutics 141 2020-01-30
2019 Hristo Svilenov, Gerhard Winter
Rapid sample-saving biophysical characterisation and long-term storage stability of liquid interferon alpha2a formulations: Is there a correlation?
published pages: 42-50, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2019.03.025
International Journal of Pharmaceutics 562 2020-01-30
2019 A. Kulakova, S. Indrakumar, P. Sønderby, L. Gentiluomo, W. Streicher, D. Roessner, W. Frieß, G. H.J. Peters, P. Harris
Structural-stability studies on recombinant human transferrin
published pages: , ISSN: , DOI: 10.1101/742957
bioRxiv 2020-01-30
2020 Andreas Tosstorff, Tim Menzen, Gerhard Winter
Exploring Chemical Space for New Substances to Stabilize a Therapeutic Monoclonal Antibody
published pages: 301-307, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2019.10.057
Journal of Pharmaceutical Sciences 109/1 2020-01-30
2020 Alina Kulakova, Sowmya Indrakumar, Pernille Sønderby, Lorenzo Gentiluomo, Werner Streicher, Dierk Roessner, Wolfgang Frieß, Günther H.J. Peters, Pernille Harris
Small angle X-ray scattering and molecular dynamic simulations provide molecular insight for stability of recombinant human transferrin
published pages: 100017, ISSN: 2590-1524, DOI: 10.1016/j.yjsbx.2019.100017
Journal of Structural Biology: X 4 2020-01-30
2018 Roberto Fernandez-Alvarez, Žiga Medoš, Zdeněk Tošner, Alexander Zhigunov, Mariusz Uchman, Stefan Hervø-Hansen, Mikael Lund, Marija Bešter-Rogač, Pavel Matějíček
Total Description of Intrinsic Amphiphile Aggregation: Calorimetry Study and Molecular Probing
published pages: 14448-14457, ISSN: 0743-7463, DOI: 10.1021/acs.langmuir.8b03462
Langmuir 34/47 2020-01-30
2020 Lorenzo Gentiluomo, Dierk Roessner, Werner Streicher, Sujata Mahapatra, Pernille Harris, Wolfgang Frieß
Characterization of Native Reversible Self-Association of a Monoclonal Antibody Mediated by Fab-Fab Interaction
published pages: 443-451, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2019.09.021
Journal of Pharmaceutical Sciences 109/1 2020-01-30
2019 Andreas Tosstorff, Hristo Svilenov, Günther H.J. Peters, Pernille Harris, Gerhard Winter
Structure-based discovery of a new protein-aggregation breaking excipient
published pages: 207-216, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2019.09.010
European Journal of Pharmaceutics and Biopharmaceutics 144 2020-01-30
2019 Marcello Martinez Morales, Matja Zalar, Silvia Sonzini, Alexander P. Golovanov, Christopher F. van der Walle, Jeremy P. Derrick
Interaction of a Macrocycle with an Aggregation-Prone Region of a Monoclonal Antibody
published pages: 3100-3108, ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.9b00338
Molecular Pharmaceutics 16/7 2020-01-30
2020 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
Advancing Therapeutic Protein Discovery and Development through Comprehensive Computational and Biophysical Characterization
published pages: , ISSN: 1543-8384, DOI: 10.1021/acs.molpharmaceut.9b00852
Molecular Pharmaceutics 2020-01-30
2019 Dillen Augustijn, Sujata Mahapatra, Werner Streicher, Hristo Svilenov, Alina Kulakova, Christin Pohl, Ã…smund Rinnan
Novel non-linear curve fitting to resolve protein unfolding transitions in intrinsic fluorescence differential scanning fluorimetry
published pages: 506-517, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2019.06.001
European Journal of Pharmaceutics and Biopharmaceutics 142 2020-01-30
2019 Lorenzo Gentiluomo, Vanessa Schneider, Dierk Roessner, Wolfgang Frieß
Coupling Multi-Angle Light Scattering to Reverse-Phase Ultra-High-Pressure Chromatography (RP-UPLC-MALS) for the characterization monoclonal antibodies
published pages: , ISSN: 2045-2322, DOI: 10.1038/s41598-019-51233-6
Scientific Reports 9/1 2020-01-30
2019 Matja Zalar, Sowmya Indrakumar, Colin W. Levy, Richard B. Tunnicliffe, Günther H. J. Peters, Alexander P. Golovanov
Studies of the oligomerisation mechanism of a cystatin-based engineered protein scaffold
published pages: , ISSN: 2045-2322, DOI: 10.1038/s41598-019-45565-6
Scientific Reports 9/1 2020-01-30
2020 Hristo L. Svilenov, Alina Kulakova, Matja Zalar, Alexander P. Golovanov, Pernille Harris, Gerhard Winter
Orthogonal Techniques to Study the Effect of pH, Sucrose, and Arginine Salts on Monoclonal Antibody Physical Stability and Aggregation During Long-Term Storage
published pages: 584-594, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2019.10.065
Journal of Pharmaceutical Sciences 109/1 2020-01-30
2019 Silvia Sonzini, Maria Laura Greco, Thais Cailleau, Lauren Adams, Luke Masterson, Balakumar Vijayakrishnan, Conor Barry, Phillip Howard, Peter Ravn, Christopher F. van der Walle
Improved Physical Stability of an Antibody–Drug Conjugate Using Host–Guest Chemistry
published pages: , ISSN: 1043-1802, DOI: 10.1021/acs.bioconjchem.9b00809
Bioconjugate Chemistry 2020-01-30
2019 Sowmya Indrakumar, Matja Zalar, Christin Pohl, Allan Nørgaard, Werner Streicher, Pernille Harris, Alexander P. Golovanov, Günther H.J. Peters
Conformational Stability Study of a Therapeutic Peptide Plectasin Using Molecular Dynamics Simulations in Combination with NMR
published pages: 4867-4877, ISSN: 1520-6106, DOI: 10.1021/acs.jpcb.9b02370
The Journal of Physical Chemistry B 123/23 2020-01-30
2019 Hristo Svilenov, Gerhard Winter
The ReFOLD assay for protein formulation studies and prediction of protein aggregation during long-term storage
published pages: 131-139, ISSN: 0939-6411, DOI: 10.1016/j.ejpb.2019.02.018
European Journal of Pharmaceutics and Biopharmaceutics 137 2020-01-30
2017 Pernille Harris
PIPPI – Protein-excipient Interactions and Protein-Protein Interactions in formulation – ERC
published pages: 75-77, ISSN: 2398-7073, DOI: 10.21820/23987073.2017.8.75
Impact 2017/8 2019-07-08
2018 Hristo Svilenov, Lorenzo Gentiluomo, Wolfgang Friess, Dierk Roessner, Gerhard Winter
A New Approach to Study the Physical Stability of Monoclonal Antibody Formulations—Dilution From a Denaturant
published pages: 3007-3013, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2018.08.004
Journal of Pharmaceutical Sciences 107/12 2019-02-26

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