Inbiopharma is a pharmaceutical laboratory authorized August 2006 by Spanish Medicinal Product Agency [Agencia española del Medicamento] to manufacture investigational medicinal products (cell therapy) (MIA Reference 1135; NCA Company Reference 4206-E).
Inbiopharma was born to service the needs of pharmaceutical, sanitary and biotech industries under the strict Good Manufacturing Procedures (GMP) standard. Inbiopharma has produced a bilayer engineered skin for topical use, to treat a rare genetic skin condition. This medicinal product has been applied to 11 patients within clinical trial No. Eudra CT 2005-002329-30 ("Ensayo clínico comparativo, abierto, multicéntrico, para evaluar la eficacia y seguridad de una nueva terapia con piel quimérica cultivada para el tratamiento de las lesiones cutáneas de los pacientes con Epidermolisis Bullosa"), which has recently been completed.
Manufacturing of this innovative medicinal product under EU GMP was only possible after a strong commitment of the whole organization to improve infrastructure (Clean rooms), personnel qualification, documentation, etc., so that cell therapy protocols meeting all legal requirements and evolving standards can be undertaken. Work at Inbiopharma is always performed with Standard Operating procedures (SOPs) under strong Quality control (QC) surveillance.
Current Objectives of Inbiopharma:
