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
Programme(s)
Funding Scheme
RIA - Research and Innovation actionCoordinator
501 15 Boras
Sweden
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Participants (26)
TS10 4RF Redcar Cleveland
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22100 Lund
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DD1 4HN Dundee
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WC1E 6BT London
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35122 Padova
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751 25 Uppsala
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08036 Barcelona
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
08036 Barcelona
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37126 Verona
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10123 TORINO
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113 31 Stockholm
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223 62 LUND
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
111 24 Stockholm
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
30174 Venezia Mestre
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20122 Milano
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60064 North Chicago Il
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151 85 Sodertaelje
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55218 Ingelheim
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4002 Basel
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64293 Darmstadt
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CT13 9NJ Sandwich
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4070 Basel
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65929 Frankfurt Am Main
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49131 Petach Tivka
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3994 VZ Houten
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35128 Padova
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