Scientific Technological Platforms
Advanced Therapies Unit
For further information on the services provided or rates, please contact directly the person in charge of the Platform..
Production of advanced therapy drugs for clinical use under good manufacturing standards. Certificate Nº: ES/005I/19.
- Adult allogeneic allogeneic peripheral blood non-expanded INF-gamma+ differentiated T lymphocytes after stimulation with Cytomegalovirus peptide (PEI: 18-143).
- Adult allogeneic allogeneic peripheral blood non-expanded INF-gamma+ differentiated T lymphocytes after stimulation with Epstein-Barr virus peptides.
- Differentiated adult allogeneic peripheral blood T lymphocytes not expanded INF-gamma+ after stimulation with Adenovirus peptides.
- Adult allogeneic allogeneic non-expanded peripheral blood differentiated T lymphocytes INFgamma+ after stimulation with BK polyomavirus peptide.
Liver cell banking: Procurement, evaluation, processing, preservation, storage and distribution of liver cells for implantation.
Centralization of quality control services during the validation and clinical production phases.
- Determination of mycoplasma DNA in cell culture supernatants and biological fluids according to Ph. Eu.
- Determination of endotoxins in cell cultures, media and reagents, according to Ph. Eu.
- Gram staining.
- Sterility test according to Ph. Eu. 2.6.1
- Sterility test by rapid bact-Alert techniques.
- Growth promotion test, according to Ph. Eu.
- Environmental and surface microbiological control of ISO classified facilities: air volumetric; with sedimentation plates and contact surfaces.
Technical support during pre-clinical development, validation and subsequent clinical production of an MTA.
Development of documentation and protocols.
- Development of protocols for the production of MTAs for clinical application: media fill protocol, validation protocol, production protocol, manufacturing guide, source, sample, intermediate and finished product specifications, and release certificate.
Scientific advice to regulatory agencies.
Specialized training in best practice quality systems, GxP.