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

Project description

Learning about real-life handling of protein drugs

Innovative protein drugs, genetically engineered versions of human proteins, have the capacity to cure previously incurable diseases. However, they are sensitive due to their complex structure. For instance, they react to shaky transportation or being left beside a sunny window by patients. The EU-funded RealHOPE project will measure real-life events during drug handling by applying smart tag technologies. It will also conduct focus interviews with personnel in hospital pharmacies, clinics and with patients and caregivers to understand current handling practice and what the desired handling instructions and limitations are. These insights will be used to design in use mimicking stability protocols for protein drugs and ultra scaled-down devices for stability assessment.

Objective

RealHOPE will create an understanding of the real-life handling of protein drugs in hospital pharmacy, clinics and in the hands of patients by applying smart tag technologies. Different parameters will be logged and combined with protein characterisation at different stages, as well as with information from EFPIA partners on their drugs in use. Statistical evaluation of the data will be used to identify patterns in handling that are linked to protein destabilisation occurrence and type of protein degradation. Focus interviews with personnel in hospital pharmacies, clinics and with patients/care givers will be used to understand current handling practice and what the desired handling instructions and limitations are. These insights will be used to design in-use mimicking stability protocols for the protein drugs in the project. Ultra-scaled-down devices for stability assessment will be designed to be used in early phase for efficient development cost effective and safe future protein therapies. Protocols and devices will be validated towards the collected handling data base. Interventions in hospital pharmacies using e.g. compounding robots will be investigated. Techniques to assess e.g. aggregate formation in the final drug preparation situation will be evaluated together with SMEs producing analytical tools and hospital pharmacists. The collected data and interviews will form the base of development of teaching materials directed towards different target groups: hospital pharmacists, nurses and patients/care givers. App developers will be active in this part to design attractive and efficient apps for teaching and collecting therapy performance data.

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Keywords

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Programme(s)

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Topic(s)

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Funding Scheme

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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-JTI-IMI2-2020-20-two-stage

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Coordinator

RISE RESEARCH INSTITUTES OF SWEDEN AB
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 672 657,50
Address
BRINELLGATAN 4
501 15 Boras
Sweden

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Region
Södra Sverige Västsverige Västra Götalands län
Activity type
Research Organisations
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 672 657,50

Participants (26)

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