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Project

From bench to bedside: accelerating the clinical development of cell therapy innovations by "lean" gmp manufacturing of ATMP.

To specifically advance translation initiatives of cell therapeutic advanced therapeutic medicinal products (ATMP) into commercially viable and safe treatments and hence, overcome regulatory, developer-related and value chain-related challenges, a consortium of stakeholders along the value chain, will, in collaboration with the sponsor, drive the ATMP through the early clinical trials with the objective to generate a lean manufactured and effective ATMP. The key concept is to task each of the specific necessary steps to the entity that is best suited for the task. It is important for all team members to understand, to some degree, the whole process involved in product development to adequately balance what needs to be done and more importantly when to do it as time and resources are not unlimited. Concrete tasks of this partnership are (i) upgrade the research 'product and process' to a lean manufacturing process with built-in quality measures, (ii) revise the whole process to generate an efficient, scalable process from patient to lab and back to patient, (iii) interact from an early stage with the Committee for Advanced Therapies (CAT) in the process of marketing authorization licensing and (iv) will support the sponsor in the licensing/spin-out of their ATMP project. In collaboration with an external consultant, different business models will be evaluated from which one concrete business case will be designed and serve as the basis to apply for further funding.
Date:1 May 2016 →  30 Nov 2016
Keywords:CELL THERAPY
Disciplines:Immunology