Case Study

Dry powder haemostat delivery device

Our client, Dutch biotech firm ProFibrix, had developed Fibrocaps™ – a dry powder fibrin sealant that is based on a mixture of the fibrinogen and thrombin proteins, which occur naturally in blood. When applied to a wound during a surgical procedure, Fibrocaps™ precipitates clotting and stops bleeding. Unlike existing liquid Fibrin sealant sprays, which need to be refrigerated and mixed before use, Fibrocaps™ is prepared in seconds and can be stored at room temperature. However, applying a fine particle powder, that becomes sticky when moist, to a precise location presents a number of technical challenges, which is why ProFibrix came to Team.

ProFibrix had already conceived a concept to deliver the powder via a handheld device but needed a partner to further develop the concept into a solution suitable for use by surgeons in Phase II clinical trials.

Profibrix are a start-up organisation and needed a partner which was able to provide a full service offering with the necessary skills and experience required to manage the development from concept through to manufactured and tested clinical trial supplies. They also needed an organisation that could work flexibly and creatively to meet the tight timescales of the programme and ensure the project stage gates were met to allow them to continue on their development path and meet the requirements of their investors.

In line with our user-centred, risk-managed approach, we developed ProFibrix’s concept into a refined design and proof of principle prototypes. We then rapidly manufactured clean room injection moulded / hand-assembled devices suitable for use in European Phase II clinical trials. As part of the development we developed a novel technology for propelling the powder in a controlled, accurate manner. The device met all technical and user requirements defined in the specification.

Following initial positive results, a second generation device design was developed incorporating several technical and user enhancements for release early in 2011 into Phase II trials in the US and Europe.

The programme is on-going with a device currently in development to enable Profibrix to enter Phase III pivotal trials and scale up for commercial launch.

“We selected Team not just because of their technical excellence but also because of their ability to listen, work with us and understand our needs. As a young company we greatly value Team’s flexibility and willingness to work with us in partnership. As for Fibrocaps™, clinical trial data has been very encouraging and we’ve recently extended our phase II clinical studies in Europe and the US.”

Eliane Schutte, Chief Development Officer, Profibrix