ANNUAL FINANCIAL REPORT 2010 2010 - TiGenix

In Spain, since the passage of Order SCO/3461/2003, TiGenix’eASC development stage products have been considereddrugs and therefore must be manufactured in compliance withGMP. Because of this requirement, Cellerix (now a subsidiaryof TiGenix) was obliged to adapt its facilities, procedures andpersonnel to the requirements established for pharmaceuticallaboratories, successfully passing the inspection of the SpanishDrug Agency and receiving certification as a pharmaceuticallaboratory in 2004 (Reg. No. 4146-E). The Company hasestablished a Quality Control system for its productionprocesses in line with standard pharmaceutical practice andapplicable national and international guidelines to ensurethe quality and safety of the finished product. External andself-review audits are conducted periodically along withself-inspections of the Quality System, including two AEMPSinspections, four audits of the Chamber of Commerce forISO 9001:2000 certification and audits by investors prior to thefinancing negotiations.6.5.2 ChondroMimeticProduct and technologyChondroMimetic is an-off-the shelf scaffold for the singlestep treatment of small osteochondral defects and small focalchondral lesions having possible underlying subchondralbone plate damage. These lesions often occur as a resultof sports injuries and other minor trauma and involve thecartilage as well as the underlying bone. A major advantage ofChondroMimetic as a treatment for small osteochondral lesionsis that it provides a means for treating both articular cartilageand the underlying subchondral bone. This feature addresseskey surgeon concerns that, much like trying to build a houseon a faulty foundation, the repair of osteochondral defects ismeaningless unless the inevitable damage to the subchondralbone is also addressed.• Cell-mediated resorption: Natural composition encouragesresorption via natural tissue-turnover mechanisms thatclosely match the resorption rate of ChondroMimetic tothe rate of new tissue formation. This feature reduces therisk of cyst and other adverse tissue formation sometimesassociated with synthetic materials.• Tissue specific structure: Two seamlessly integrated layerssupport the separate yet simultaneous repair of bone andcartilage.• Optimised pore architecture: Highly interconnected,optimally sized pores allow infiltration of cells andbiomolecules throughout the 3D implant.• Novel shape memory: One-of-a-kind shape memoryand a distinctive self-contouring capacity facilitate easy,arthroscopic delivery and ensure perfect fit to the size andshape of the defect site.• Activation of other therapies: The high loading efficiencyand superior retention shown in recent research with PRPmakes ChondroMimetic highly suitable for combinationtherapies 37 .The required and underlying steps resulting in an effectivemode of action and treatment of small osteochondral defectswith ChondroMimetic are presented in the illustrations below(Figure 6.5).The key characteristics of ChondroMimetic are the following:• Natural composition: Three natural biomaterials (collagen,glycosaminoglycan, calcium phosphate) are combined toprovide an optimal environment for cell replication andnatural tissue regeneration 36 .36 Lynn et al., J Biomed Mater Res A, 2010 Mar 1;92(3):1057-65; BA Harley et al.,J Biomed Mater Res A, 2010 Mar 1;92(3):1066-77; BA Harley et al., J BiomedMater Res A, 2010 Mar 1;92(3):1078-93; AK Lynn et al., J Biomed Mater Res BAppl Biomater, 2004 Nov 15;71(2):343-54.37 A Getgood et al., Poster, British Association for Repair of the Knee, Edinburgh,April 2009120 • TiGenix • Rights Offering