ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

6.14.6 Manufacturing & logisticsCell-based medicinal products must be manufactured by alaboratory authorised by the regulatory authorities and must becarried out in compliance with Good Manufacturing Practices(“GMP”). These requirements also apply to the medicinesmanufactured for use in clinical trials.Cellerix’ cellular therapy medicine facility is authorised by theSpanish Medicines and Medical Devices Agency (Registrationnumber: 4.190-E) as a pharmaceutical laboratory whichmanufactures cellular medicinal products for investigationaluse (clinical trials) and for commercial use. For the productionof cells for clinical use, Cellerix applies a specific and effectivepharmaceutical quality assurance system in compliance withthe medicinal products standards of the European Unionand GMP.Throughout all of Cellerix’ manufacturing processes, thereare different quality controls to guarantee that the productcomplies with the adequate specifications for use. Of particularimportance are the controls applied during the process, on rawmaterials, the finished product before it is packaged and afterpackaging. Furthermore, Cellerix conducts microbiological andenvironmental controls and process controls to ensure that themanufacturing conditions are compliant for the distributionof the finished product. All of the materials used through themanufacturing process are reviewed and approved beforeuse to guarantee that each one complies with the applicablespecifications. For the performance of certain quality controlanalyses and other activities of interest, Cellerix has contractswith officially approved, specialised external companieswhich establish the conditions and obligations of each oneof the parties.The characterization of eASCs has been established in termsof, identity (in terms of phenotypic profile), purity, potency,morphology, viability and cell growth kinetic according tothe Guideline on Cell-Based Medicinal Products (EMEA/CHMP/410869/2006) and the Reflection Paper on Stem Cells(EMA/CAT/571134/2009, adopted on January 14, 2011) in orderto set the routine controls that will be applied at final productrelease as well as those to be performed at different stages ofthe manufacturing process to guarantee the batch consistency.External and self-review audits are conducted periodicallyalong with inspections of the Quality System, includingtwo inspections by the Spanish Medicines and MedicalDevices Agency (“Agencia Española De Medicamentos YProductos Sanitarios”) (“AEMPS”), four audits of the Chamberof Commerce for ISO 9001:2000 certification and audits byinvestors prior to the financing negotiations.In Spain, since the Order SCO/3461/2003 came into force,Cellerix’ products have been considered medicinal productsand therefore must be manufactured in compliance with GMP.Because of this requirement, Cellerix was obliged to adaptits facilities, procedures and personnel to the requirementsestablished for pharmaceutical laboratories, successfullypassing the inspection of the AEMPS and receiving certificationas a pharmaceutical laboratory in 2004. Cellerix has establisheda Quality Control system for its production processes in linewith standard pharmaceutical practice and applicable nationaland international guidelines to ensure the quality and safety ofthe finished product.The logistics surrounding Cellerix’ clinical stage productsincludes the transport of the finished product in a specialtemperature controlled kit, which can maintain temperature for5 days, ensuring sufficient time for transport and implantation.The shipping process has been fully validated with twospecialist courier services. Based on its experience with thesecompanies and the proximity of the manufacturing facility tothe Madrid international airport of Barajas, Cellerix believesit can reliably deliver the finished product to treatment sitesanywhere in Europe, within 24 hours.6.14.7 Intellectual propertyOverview of Patents and Patent ApplicationsThe protection of Cellerix’ intellectual property is a strategicpart of its business and Cellerix currently owns, or has inlicensed,20 granted patents and 66 patent applicationsdistributed across 17 families. In addition Cellerix currently has13 registered trademarks in Europe, as well as 3 registrationpending trademarks in the US.LicensesExcept in the case of PCT Publication Number WO2007065927,Cellerix holds the exclusive rights to the patents listed beloweither through exclusive ownership of the patents and patentapplications or otherwise as exclusive licensees or by coownershipagreements with exclusive licensee provisions.144 • TiGenix • Rights Offering