Regio Zuid | Rapid Interventional Stem cells Platform 2.0 (RISP)

The goal of this project is to build and test a prototype of a modular remote controlled (stem) cell-processing platform, which would allow for safe regulatory compliant release of (stem) cell products (for example Neuro-Cells) anywhere in the world. This platform will be monitored closely on a plethora of process and product quality parameters, which will be send encrypted to a dedicated quality control manager using specifically designed software. To achieve this goal, project applicants Neuroplast BV and Quality by design BV will join forces and combine their existing knowledge and infrastructure and further innovate to fill in the missing components. In part funded by OP-Zuid Neuroplast already created a prototype cell-processing device called Amaryllis. With this prototype Neuroplast was able to produce robustly its product Neuro-Cells and obtain a GMP license for its production facility in Geleen. Due to new regulation (Medical device directives January 2017) a clinical trial is needed to obtain a CE certificate class 2B for Neuroplast’s platform. The clinical trials are in preparation and scheduled to start begin 2019. However, the new EU-ATMP GMP directives (launched November 2017 and in force May 2018) offers a solution and a very competitive opportunity for Neuroplast with its platform, which is upgraded to RISP (Rapid Interventional Stem cells Platform). The challenges for Neuroplast BV are to redefine the original, under CE label operating platforms, to a fully GMP controlled local (in hospital) production of its product Neuro-Cells using the new RISP with a sophisticated and automated central organized GMP monitoring and product release (in GMP facility Geleen) of the local produced Neuro-Cells batches. The new business model is completely compliant with the new 2017 and 2018 regulation and Neuroplast is fully responsible for the total manufacturing and release of the product Neuro-Cells and protected by a comprehensive GMP license to avoid misuse or unauthorized side production of Neuro-Cells alike products. With this new platform, building a GMP manufacturing plant in every country is no longer necessary, saving both on building and maintenance costs, but also on the logistical costs of transporting bone-marrow/stem cells to and from hospitals. Patients can be treated autologous within 6 to 8 hours after the collection of bone marrow and enabling the use of anti-inflammatory active stem cells in the acute phase of diseases. In a CrossRoads2 study, the feasibility of a batch record system was investigated for the processing platforms (RISP-CCU). This collaboration with Quality by Design (QbD) was positive and has led to this MIT-R&D project. The following R&D project objectives have been formulated:.• The specific design of the RISP platform has to be changed from Amaryllis. The different pressures and resulting airflow have to be adapted to the new legislation;.• The prototype of the batch record system needs to be finalised, by building the interfaces, support automatization; A control centre needs to be developed at QC department Neuroplast;.• RISP including the batch record system including software and servers for remote quality control has to be field-tested and validated against the on-site quality control. If they correspond the project is a resounding success.