12 October 2009
Team Consulting assists ProFibrix to take dry powder fibrin sealant to clinical trial
Team builds prototypes for innovative Dutch biotech firm
12 October 2009, Cambridge UK – Team Consulting has assisted a Dutch biotech firm, ProFibrix, in taking a step toward the launch of a ground-breaking new wound-sealing product.
Based in Leiden, the Netherlands, ProFibrix is developing Fibrocaps™, a dry powder fibrin sealant, based on a mixture of the proteins fibrinogen and thrombin which occur naturally in blood. When applied to a wound Fibrocaps™ precipitates clotting and stops bleeding that occurs during surgery or after injury.
Unlike existing liquid Fibrin sealant sprays, which need to be refrigerated and mixed directly before use, Fibrocaps™ are prepared in seconds and can be stored at room temperature.
However, applying a powder, which comprises fine particles that become sticky when moist, to bleeding sites presents many technical challenges.
ProFibrix conceived a method of application by which a hand-held device ‘blows’ the sterile product onto the wound. The company sought a partner to define a technical design and produce prototypes that would enable ProFibrix to move to phase II clinical trials.
Team Consulting was selected to develop a prototype device, compliant with ISO13485, the quality standard which governs the design and manufacture of medical devices.
“As an expanding life sciences technology development firm, Team is excited to be assisting ProFibrix to develop an innovative solution to an important medical challenge,” said Team Consulting’s Commercial Director, Helen Slaski.
She said: “As a company centred in life science technology, we are pleased that our knowledge and our ability to build teams comprising both technologists and end users has enabled us to provide ProFibrix with a device that enabled them to move to clinical trials.”
Team took conceptual ideas and, in conjunction with clinical users, developed them through a series of product definition and technical workshops. User feedback enabled refinement of a design and, following rigorous testing and development, the project team arrived at a proof of principle.
In just four weeks, Team completed the stainless steel tooling needed to produce injection moulded components of the application device, so enabling the rapid manufacture of disposable prototypes.
ProFibrix has now entered Phase II clinical trials using the device designed and built by Team.
Jaap Koopman, Chief Executive Officer of ProFibrix, said: Team’s work has assisted us in taking Fibrocaps™ to a Phase II clinical trial and we are looking forward to seeing the results. Team was selected for the project, not only 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 valued Team’s flexibility and willingness to work with us in partnership.”
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For more information, please contact:
Helen Slaski. Team Consulting Ltd
info@team-consulting.com
+44 (0) 1799 532700
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