The Niño Jesús Hospital in Madrid incorporates the first next-generation Integral Clean Room in Europe
The Community of Madrid’s public paediatric Hospital Niño Jesús has incorporated a next-generation integral Good Manufacturing Practice Facility, the first of its kind in Europe, for the development of advanced therapies. A facility that is certified as Good Manufacturing Practice (GMP) is a clean room used to make sure that pharmaceutical products are routinely created and monitored in accordance with highest quality standards. The standards are defined to reduce risks that cannot be completely avoided through testing the finished goods. This particular type of clean room cultivates stem cells as biomaterials to produce medicinal products for the treatment of children’s cancer. The biomaterials created through this technique are being tested in a clinical trial for children suffering from major solid malignancies, such as brain tumours.
The installation of this equipment at the healthcare centre is part of an R&D collaboration agreement signed in 2020 by the Biomedical Research Foundation of the Hospital Niño Jesús and the Israeli company Orgenesis.
The Israeli equipment is a modular unit worth more than two million euros that was designed and built to meet the highest medication manufacturing standards. It is intended to automate the operations inside of it in order to make them faster and more uniform. One of its goals is to optimise and lower the cost of producing this sort of biomaterial, such as pharmaceuticals.
The module is 12.5 meters long,2.5 meters wide and weighs 20 tons. It is already installed at the hospital premises. It had to be transported by road on a special vehicle from France, where it was initially constructed. Its ultimate positioning required the deployment of a heavy-duty crane.
For kids who are enrolled in a clinical study and have large solid tumours, this facility is developing a biomaterial to treat paediatric cancer. The biomaterial is made up of antitumor lymphocytes that have been extracted from each patient and multiplied in a lab to treat the tumour more successfully after being administered as an additional medication.
These biomaterials, which are now only utilised for compassionate purposes, can already be manufactured at the Hospital Niño Jesús using the children’s own cells. In other words, they are used as medication when patients are no longer benefiting from standard treatments. A clinical trial for one of these therapies will be conducted, and this innovative modular GMP facility will also be validated by the Spanish Agency for Medicines and Health Products (AEMPS) within the same procedure.
Paediatric Centre for Advanced Research
This latest generation technology is in addition to the conventional clean room that has been in place at the Niño Jesús Children’s Hospital for 13 years, known as the Advanced Therapy Drug Manufacturing Unit. It was established in 2010 as the first of its sort in Spain, capable of offering patients cutting-edge therapies which include gene, cell, and tissue engineering within the context of a public hospital. It has made the hospital one of the world’s leaders in the development and production of these types of paediatric therapies.
The GMP facility generates biomaterials based on cultivated cells that can be altered through gene therapy prior to being combined to yield human tissues. These biomaterials are all used to treat ailments for which there is currently no effective treatment. As an illustration, consider advanced childhood cancer, unfavourable transplantation reactions, bone necrosis, autoimmune neurological conditions, etc.
These therapies’ primary goal is to replace existing treatments that can no longer provide patients with a therapeutic solution. One of the prime examples of what happens when research and patient care work together can be found at the Niño Jesús Children’s Hospital in Madrid, where researchers are in constant interaction with the kids and their families and are therefore able to recognize their needs firsthand.
The Foundation for Biomedical Research of the Niño Jesús University Hospital (FHUNJ), which is part of the BIOMATDB project consortium, administers all hospital research. The FHUNJ contributes to the outcomes of the said European project not only by means of their experience with the GMP facility as a producer of biomaterials, but also through the needs of other types of biomaterials that are used as part of regular treatments in the hospital’s departments like traumatology, stomatology, ophthalmology, cardiology, and so on.
Keywords
GMP Facility, advanced therapies, medicaments, tumours, children’s cancer