Real World Handling of Protein Drugs - Exploration, Evaluation and Education

Información del proyecto

RealHOPE

Identificador del acuerdo de subvención: 101007939

DOI

10.3030/101007939

Proyecto cerrado

Fecha de la firma de la CE 5 Julio 2021

Fecha de inicio 1 Julio 2021

Fecha de finalización 30 Junio 2025

Financiado con arreglo a

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coste total

€ 7 132 608,75

Aportación de la UE

€ 3 139 983,75

Coordinado por

RISE RESEARCH INSTITUTES OF SWEDEN AB
Sweden

CORDIS proporciona enlaces a los documentos públicos y las publicaciones de los proyectos de los programas marco HORIZONTE.

Los enlaces a los documentos y las publicaciones de los proyectos del Séptimo Programa Marco, así como los enlaces a algunos tipos de resultados específicos, como conjuntos de datos y «software», se obtienen dinámicamente de OpenAIRE .

Resultado final

Open Research Data Pilot (2)

First version of data management plan.

First version of data management planDescribes kind of data generated throughout the project their storage handling and securityThe consortium must address the following data protection issues in the Data Management Plan especially sections 4 Data security and 5 Ethics1 The consortium members must confirm that contact details of the Data Protection Officer DPO are made available to all data subjects involved in the research For the members of the consortium not required to appoint a DPO under the General Data Protection Regulation a detailed data protection policy for the project must be elaborated and kept on file It must be provided to IMI JU upon request2 The concerned consortium members must check and confirm to IMI JU if special derogations pertaining to the rights of data subjects or the processing of personal data have been established under the national legislation of the country where the research takes place and provide a declaration of compliance with respective national legal frameworks3 Details of the observationtracking activities such as shadowing of healthcare personnel and tracking patients with the electronic tags attached to drug containers must be provided The applicant must explain if these activities will involve personal data collectionprocessing 4 A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants must be provided5 Detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participants6 A description of the anonymisationpseudonymisation techniques that will implemented must be provided7 In case personal data are transferred from the EU to a nonEU country or international organisation confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPR must be provided in regard to possible transfer of data from EU to USAIsraelSwitzerland8 In case personal data are transferred from a nonEU country to the EU USAIsraelSwitzerland to the EU partners confirmation that such transfers comply with the laws of the country in which the data was collected must be providedThe applicant must explain if any research activities to be performed in a nonEU country will result in transfers of data or materials tofrom nonEU countries If this is the case the concerned consortium members must provide details on the materials eg smart tags which will be imported toexported intofrom the EU and confirm that the adequate importexport authorisations required by nationalEU legislation have been obtained prior to the start of the research activity raising ethics issue and are kept on file and provided to IMI JU upon request

Data management plan mid-term.

Data management plan midtermUpdate of the data management planThe consortium must address the following data protection issues in the Data Management Plan especially sections 4 Data security and 5 Ethics1 The consortium members must confirm that contact details of the Data Protection Officer DPO are made available to all data subjects involved in the research For the members of the consortium not required to appoint a DPO under the General Data Protection Regulation a detailed data protection policy for the project must be elaborated and kept on file It must be provided to IMI JU upon request2 The concerned consortium members must check and confirm to IMI JU if special derogations pertaining to the rights of data subjects or the processing of personal data have been established under the national legislation of the country where the research takes place and provide a declaration of compliance with respective national legal frameworks3 Details of the observationtracking activities such as shadowing of healthcare personnel and tracking patients with the electronic tags attached to drug containers must be provided The applicant must explain if these activities will involve personal data collectionprocessing 4 A description of the technical and organisational measures that will be implemented to safeguard the rights and freedoms of the data subjectsresearch participants must be provided5 Detailed information on the specific data protection informed consent procedures in regard to data processing must be provided prior to the start of the research activity raising ethics issue in case this is not addressed in the informed consent procedures for human participants6 A description of the anonymisationpseudonymisation techniques that will implemented must be provided7 In case personal data are transferred from the EU to a nonEU country or international organisation confirmation that such transfers are in accordance with Chapter V of the General Data Protection Regulation 2016679 GDPR must be provided in regard to possible transfer of data from EU to USAIsraelSwitzerland8 In case personal data are transferred from a nonEU country to the EU USAIsraelSwitzerland to the EU partners confirmation that such transfers comply with the laws of the country in which the data was collected must be providedThe applicant must explain if any research activities to be performed in a nonEU country will result in transfers of data or materials tofrom nonEU countries If this is the case the concerned consortium members must provide details on the materials eg smart tags which will be imported toexported intofrom the EU and confirm that the adequate importexport authorisations required by nationalEU legislation have been obtained prior to the start of the research activity raising ethics issue and are kept on file and provided to IMI JU upon request

Websites, patent fillings, videos etc. (1)

Project Website.

Project WebsiteA publicly accessible webpage with information on the consortium its objectives and partners Providing information for the general audience as well as for specialists in the field

Publicaciones

Peer reviewed articles (10)

Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures

Autores: Clàudia Sabaté Martínez, Leanne Amery, Giorgia De Paoli, Ulla Elofsson, Anna Millqvist Fureby, Stanley Kwok, Carmen López-Cabezas, Marika Rosenberger, Christian Schoenau, Marie Wahlgren, Mattias Paulsson
Publicado en: Journal of Pharmaceutical Sciences, 2023, ISSN 0022-3549
Editor: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2023.05.003

Interdomain Interactions Modulate Refolding Kinetics and Aggregation in a Monoclonal Antibody

Autores: Philipp Trolese, Andrea Pierangelini, Benedetta Fongaro, Patrizia Polverino de Laureto
Publicado en: Journal of the American Society for Mass Spectrometry, 2025, ISSN 1044-0305
Editor: Elsevier BV
DOI: 10.1021/jasms.5c00166

Relationships between surface tensiometry properties and fluorescence intensity of dark and light exposed monoclonal antibody Nivolumab/Opdivo® by using the contact angle method: A pilot study

Autores: Giorgia Miolo, Elisabetta De Diana, Patrizia Polverino de Laureto, Nicola Realdon, Sergio Rossi, Davide Rossi
Publicado en: Journal of Pharmaceutical Sciences, Edición 114, 2025, Página(s) 103823, ISSN 0022-3549
Editor: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2025.103823

Managing antibody stability: Effects of stressors on Ipilimumab from the commercial formulation to diluted solutions

Autores: Benedetta Fongaro, Valentina Cian, Francesca Gabaldo, Giorgia De Paoli, Giorgia Miolo, Patrizia Polverino de Laureto
Publicado en: European Journal of Pharmaceutics and Biopharmaceutics, 2022, ISSN 0939-6411
Editor: Elsevier BV
DOI: 10.1016/j.ejpb.2022.05.005

Towards a better understanding of light-glucose induced modifications on the structure and biological activity of formulated Nivolumab

Autores: Elisabetta De Diana, Elena Rizzotto, Ilenia Inciardi, Luca Menilli, Marina Coppola, Patrizia Polverino de Laureto, Giorgia Miolo
Publicado en: International Journal of Pharmaceutics, Edición 654, 2024, Página(s) 123926, ISSN 0378-5173
Editor: Elsevier BV
DOI: 10.1016/j.ijpharm.2024.123926

Exploring industry stakeholder perspectives on a clinical testbed for evaluating the handling of protein drugs in hospitals

Autores: Jesper Arvidsson, Yaser Alkhatib, Marc Egen, Ulla Elofsson, Anna Fureby Millqvist, Carmen López-Cabezas, Marie Wahlgren, Marika Rosenberger, Mattias Paulsson
Publicado en: Journal of Pharmaceutical Sciences, Edición 114, 2025, Página(s) 103704, ISSN 0022-3549
Editor: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2025.103704

Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity

Autores: Elia Cappelletto, Stanley C. Kwok, Léa Sorret, Nathalie Fuentes, Annette M. Medina, Stephen Burleigh, Jonas Fast, Isla S. Mackenzie, Anna Millqvist Fureby, Mattias Paulsson, Marie Wahlgren, Ulla Elofsson, Angela Flynn, Giorgia Miolo, Lina Nyström, Patrizia Polverino De Laureto, Giorgia De Paoli
Publicado en: Journal of Pharmaceutical Sciences, Edición 113, 2024, Página(s) 2055-2064, ISSN 0022-3549
Editor: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2024.05.027

Light exacerbates local and global effects induced by pH unfolding of Ipilimumab

Autores: Elena Rizzotto, Ilenia Inciardi, Benedetta Fongaro, Philipp Trolese, Giorgia Miolo, Patrizia Polverino de Laureto
Publicado en: European Journal of Pharmaceutics and Biopharmaceutics, Edición 201, 2024, Página(s) 114387, ISSN 0939-6411
Editor: Elsevier BV
DOI: 10.1016/j.ejpb.2024.114387

How are we handling protein drugs in hospitals? A human factors and systems engineering approach to compare two hospitals and suggest a best practice

Autores: Clàudia Sabaté-Martínez, Mattias Paulsson, Silvia González-Suárez, Ulla Elofsson, Anna Millqvist Fureby, Marie Wahlgren, Carmen López-Cabezas
Publicado en: International Journal for Quality in Health Care, Edición 36, 2024, ISSN 1353-4505
Editor: Oxford University Press
DOI: 10.1093/intqhc/mzae020

Pneumatic tube transport of trastuzumab in IV bags—Effect of headspace and surfactant on subvisible particle formation

Autores: Anna Kjellström, Ida Cederwall, Clàudia Sabaté Martínez, Stanley Kwok, Florian Rosenthal, Ulla Elofsson, Mattias Paulsson, Marie Wahlgren
Publicado en: Journal of Pharmaceutical Sciences, Edición 114, 2025, Página(s) 1142-1151, ISSN 0022-3549
Editor: John Wiley & Sons Inc.
DOI: 10.1016/j.xphs.2024.12.003