Selvita S.A. services

Having experience in both pharma and biotech R&D, we are well aware of what it means to discover a hit and transform it into a drug. You can best benefit from this “insider” experience through our integrated drug discovery services built upon:

Cell and Molecular Biology Department at Selvita performs In vitro comparative studies of biosimilar insulins and insulin analogs as well as battery of various therapeutic antibodies (e.g. TNFα, VEGF and HER2 inhibitors etc.). These studies should be comparative in nature and should be designed to have appropriate sensitivity to detect relevant differences in the response to the similar biological medicinal product and the reference medicinal product. The scope of assays is in line with EMA guidelines (Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues, EMEA/CHMP/BMWP/32775/2005_Rev. 1 and Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues, EMA/CHMP/BMWP/403543/2010 ) and includes: