“Our flexible flow cabinets can be deployed anywhere in the world. Even in disaster areas.”
January 2022
At ProCleanroom we are proud of our products and services, but even more proud of our client relationships. In this blog series client’s stories from various sectors are key. What keeps entrepreneurs in these sectors busy and in which way do cleanroom solutions play a role within their business? This time, we have a interview with Hans de Munter (CEO) from Neuroplast. A conversation with a pioneer in the area of stem cell technology, regarding hopeful techniques and flexible cleanroom solutions that make giving aid possible anywhere in the world.
Neuroplast is a company that focusses on stem cell technology. Their emphasis is on studying the treatment of paraplegia by converting the bone marrow of patients into an anti-inflammatory product that is subsequently “returned” to the patient op. Following this activity, Neuroplast searches for evidence and substantiation, allowing approval for this therapy in terms of other diseases, such as MS, ALS and traumatic brain injury.
Neuroplast was founded in 2014 and is based in Geleen, which is where they have modern facilities available for cleanroom and laboratory research, but also work areas for their team of researchers. In addition to producing the stem cell preparation and purifying bone marrow, Neuroplast also devotes a lot of time and energy on regulations, so the preparations can be processed, but equally important, can be transported, under GMP (Good manufacturing practice).
Phase 2 of the clinical trial started from November 2021: patients with paraplegia, from Spain and Denmark, were treated by use of the Neuroplast treatment method. This clinical trial should produce the evidence that the treatment for paraplegia, developed by Neuroplast, works. After phase 2, phase 3 is to follow, during which treatments will take place at a larger scale.
Hans explains: “The power of Neuroplast is our ability to adapt to new and changing regulations. We are true pioneers in our own field of expertise. After finishing the clinical-trial phases and approval of our product, we expect to be able to redirect our focus to the stage of marketing our product. Additionally, we will always be pioneers, continuously looking for new solutions and research methods”.
Challenges & solutions
Asking Hans about the challenges for Neuroplast when it comes to the purity of processes and production, he says: “The greatest challenges during the further development of this treatment are the continuous modification of rules imposed by the various (governmental)bodies and the approval from the regulators, in order to certify the production platform as a GMP-production environment.
How we solve this? In order to ensure that all testing and research methods and, above all the results, will be implemented and processed consistently, we have chosen to interconnect different labs and apply strict purity protocols at all locations.
Internally, the company is divided into public, accessible workplaces and non-accessible laboratory- and cleanroom environments, where the authorised staff is to comply with the prescribed workwear- and operational protocols. As such, we keep the purity for all areas and products at an as high as possible level. The clean rooms are continuously monitored with respect to purity. This way, we ensure the highest degree of consistency in implementing the studies and processing the results”.
