Resumen de Polyamino acid carriers in drug delivery and their production under good manufacturing practice compliance
Within the current framework of this thesis dissertation, the two first chapters have been focused on a work based on R&D activities for PAA-based materials that can be considered inside of the POC stage (or feasibility study or bench stage) before engaging the manufacturing process development. Through the synthetic technic of Ring-Opening Polymerization of N-carboxyanhydrides monomers of amino acids (ROP of NCAs) we obtained a pipeline of polymeric micelles based on Amphiphilic PAA (APAA). We modulated their physico-chemical properties in terms of electrostatic charge, secondary structure, and hydrophilic and hydrophobic compositions, to use them as carriers to transport hydrophobic APIs for drug delivery applications.
To closely reflect one of the main expertise at PTS as a company, the final chapter shows two real examples of alpha-poly(L-lysine) currently being used as part of therapies in clinical trials. For these PLys we performed the CMC activities under GMP compliance following the quality guidelines of The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to achieve the drug substance quality.
