RealHOPE

Real world handling of protein drugs - exploration, evaluation and education

Summary

Many new medicines are based on proteins, and these have dramatically improved the lives of people with a range of diseases. However, ensuring the quality of protein drug products, particularly after manufacture, is far from easy. Proteins can be affected by exposure to heat, sunlight or shaking. If stored or handled inappropriately during transport, or at the hospital, pharmacy or patient’s home, the proteins can break down, compromising the safety and efficacy of the product. RealHOPE aims to deliver knowledge and tools to address this issue.

One major project goal is to improve our understanding of how protein drugs are handled in the real world, and the effect this has on product quality. To do this, the project will use smart tag technologies to log light, temperature and shock during real-life protein handling. They will also analyse the proteins at different stages. The data gathered will be used to identify the level and type of protein degradation triggered by different aspects of handling. The project team will also interview people who work in pharmacies and clinics as well as patients and carers to understand how they currently handle protein drugs and what limitations they face.

The project will use the data from these studies to develop teaching materials, including apps, for different target groups, namely hospital pharmacists, nurses, patients, and care givers.

Ultimately, RealHOPE will aid in the development of more robust, safer protein drugs.

Participants

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EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Astrazeneca AB, Södertälje, Sweden
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Icu Medical BV, Houten, Netherlands
  • Lonza AG, Basel, Switzerland
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Deutschland GMBH, Frankfurt / Main, Germany
  • Teva Pharmaceutical Industries Limited, Netanya, Israel
Universities, research organisations, public bodies, non-profit groups
  • Azienda Ospedaliera Universitaria Integrata 'Istituti Ospitalieri Di Verona, Verona, Italy
  • Azienda Ulss N3 Serenissima, Venezia Mestre, Italy
  • Centre For Process Innovation Limited Lbg, Redcar Cleveland, United Kingdom
  • Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer, Barcelona, Spain
  • Istituto Oncologico Veneto, Padova, Italy
  • Lunds Universitet, Lund, Sweden
  • Region Uppsala, Uppsala, Sweden
  • Rise Research Institutes Of Sweden AB, Stockholm, Sweden
  • Societa Italiana Di Farmacia Clinica E Terapia, milano, Italy
  • Universita Degli Studi Di Padova, Padova, Italy
  • University College London, London, United Kingdom
  • University Of Dundee, Dundee, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Elsa Science AB, Stockholm, Sweden
  • Plurima S.A, Milano, Italy
  • Probation Labs Sweden AB, Malmö, Sweden
Patient organisations
  • Reumatikerforbundet, Stockholm, Sweden
Third parties
  • Hospital Clinic De Barcelona, Barcelona, Spain

Participants
NameEU funding in €
Azienda Ospedaliera Universitaria Integrata 'Istituti Ospitalieri Di Verona15 285
Azienda Ulss N3 Serenissima16 250
Centre For Process Innovation Limited Lbg456 035
Elsa Science AB104 500
Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer6 250
Lunds Universitet528 898
Plurima S.A14 878
Probation Labs Sweden AB41 348
Region Uppsala130 445
Reumatikerforbundet12 500
Rise Research Institutes Of Sweden AB649 779
Societa Italiana Di Farmacia Clinica E Terapia17 250
Universita Degli Studi Di Padova272 500
University College London325 349
University Of Dundee514 969
 
Third parties
NameFunding in €
Hospital Clinic De Barcelona33 750
 
Total Cost3 139 986