Helping new medicines gain regulatory approval

Gaining regulatory approval to continue the development with clinical trials is a challenging but critical step in any drug discovery pipeline. Before a test article reaches this stage, researchers must generate preclinical data demonstrating safety and efficacy compared with compounds already on the market. Numerous laboratory models can be used to obtain this data, including cell culture assays, animal models, and human tissue testing.

Pharma company Arcede Pharma, a spin-out from Respiratorius AB (Lund, Sweden) used human tissue testing to generate preclinical efficacy data for their compound RCD405.2 Reprocell's testing services in human tissue helped to demonstrate the therapeutic value of RCD405 following a request from the Swedish Medical Products Agency.