Raw Material Validation for TiGenix Ltd
TiGenix Ltd is working at the leading edge of regenerative medical technology and has developed novel collagen-based implants for the regenerative repair of bone, cartilage, ligaments and tendons that are commonly damaged during sports injuries and other trauma.
During manufacture a cross-linking agent, EDAC, is utilised and initially, the small amount of EDAC needed for early stage development was sourced from the UK. However, as the requirement for EDAC increased with GMP manufacturing scale-up, a new source was required to maintain the product's advantage as a low-cost treatment.
TiGenix Ltd identified a possible altemative source and needed independent validation that this new, cheaper source of EDAC provided material to the same specificatlon as that of the existing supplier.
What We Delivered
Using a combination of NMR (Nuclear Magnetic Resonance) and FTIR (Fourier Transform-lnfra Red) Lucideon (then Ceram) was able to analyse and directly compare the samples.
On comparison, it was determined that the new source of EDAC provided material to the same specificatlon as the existing supplier.
Value to the Client
Lucideon‘s independent validation of the new source allowed TiGenix to change supplier of EDAC, safe in the knowledge that this change would not adversely affect on-going development.
Lucideon's validation has enabled TiGenix to make a direct saving on raw material purchasing, maintaining the low-cost of the treatment for the ultimate benefit of healthcare providers and patients.