The biopharmaceutical company, Cellab CDMO, has been awarded a GMP certificate as manufacturer of advanced therapy products under the European Union (EU) standards. The AEMPS has been the entity in charge of certifying compliance with these standards.
Among many other projects, Cellab is currently involved in the manufacturing of a cell therapy product for a Phase II clinical trial using allogeneic mesenchymal cells from expanded umbilical cord tissue. This trial, authorized in Spain by the AEMPS, is being conducted in several Spanish hospitals and is aimed at treating pulmonary bronchodysplasia in premature infants, a disease that may cause death or leave significant sequelae.
In the words of Cellab CDMO's CEO, Alexandre Marfany, “Cellab CDMO's entry into the field of advanced therapy products manufacturing means becoming part of a small group of companies in Europe, in a field with an exponential growth worldwide. Advanced therapies are bringing about a paradigm shift in the treatment of both complex and chronic diseases with poor prognosis. Being part of this change, which will contribute to improving all these patients’ lives, is a great honor of which we feel very proud”.
Cellab CDMO's pharmaceutical plant, now certified for cell therapy, also has the equipment and facilities required for manufacturing many other advanced therapy products, such as CAR-T immunotherapies, TILs (Tumor-Infiltrating Lymphocytes) and cell secretome, one of the most cutting-edge lines of cell therapy.
About Cellab CDMO
Cellab CDMO has a highly trained and skilled team which together with an optimal organizational structure and size result in being extremely versatile and competitive in terms of manufacturing costs for the benefit of its clients, especially for products in the clinical trial phase. Cellab CDMO, through its strategic partners, also offers EU certified batches and full logistic services.
Cellab CDMO complements its advanced therapy product manufacturing services with process development and scale-up services for biotech companies and research groups, together with GMP cryopreservation services.
CELLAB INFO / CELLAB MEDIA
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