Xbrane Biopharma reports positive in-vitro biosimilarity data on Xlucane
Xbrane Biopharma has performed a comprehensive in-vitro biosimilarity study with several pilot scale R&D batches of Xlucane versus several batches of the reference product. The study demonstrates no significant difference of Xlucane versus the reference product on the most important parameters. This proves the quality of the product and gives us huge comfort for ongoing scale up of the production to commercial scale and the upcoming clinical trials and it allows us to accelerate the out-licensing process of the product.
In the in-vitro comparability study Xbrane has, in accordance with EMA (European Medicines Agency) and FDA (Food and Drug Administration) biosimilar guidelines, used numerous analytical methods comparing the proteins along 5 key dimensions: primary structure (amino-acid sequence), higher order structure (folding of the protein), binding characteristics (binding with the growth factor VEGFa), biological activity (activity in terms of growth inhibition on living cells) and purity. The study demonstrates no significant difference of Xlucane versus the reference product on the most important dimensions; primary structure, higher order structure, binding characteristics and biological activity. The purity was slightly lower compared to the reference product, which is being addressed through few modifications in the purification process during the scale-up of the production process.
