Patents by Inventor Barbara SIMONELLI

Barbara SIMONELLI has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).

  • MANUFACTURING PROCESS FOR THE PRODUCTION OF LINACLOTIDE
    Publication number: 20250042948
    Abstract: A manufacturing process to produce Linaclotide and its acetate salt, more particularly, to obtain amorphous High-Purity Linaclotide or its acetate salt with a chromatographic purity equal to or higher than 99.9% and a content of IMD-Linaclotide and Cys-1-?-ketone-Linaclotide impurities each one lower than 100 ppm, preferably lower than 50 ppm, more preferably lower than 40 ppm. The invention further relates to an analytical method able to detect IMD-Linaclotide and Cys-1-?-ketone Linaclotide even at 40 ppm level (LOD) and quantify IMD-Linaclotide and Cys-1-?-ketone Linaclotide even at 50 ppm level (LOQ), by Ion-Pairing Chromatography (IPC).
    Type: Application
    Filed: December 12, 2022
    Publication date: February 6, 2025
    Applicant: CHEMI SPA
    Inventors: Paola ANNONI, Silvana CAPPELLETTI, Alessandra CELONA, Barbara SIMONELLI, Stefano TURCHETTA, Lorenzo CAPPELLINI