Matteo Melandri
Tema Sinergie S.P.A.
Sales Engineer
¦ 16+ years’ experience in the radiopharmaceutical industry with extensive experience on radioisotopes and radio-therapeutical shielded production suites in cGMP, either in Europe, North America and ASIA / Oceania.
¦ Extensive experience in aseptic radiopharmaceuticals manufacturing / fill-finish (sterile filtered and terminally sterilized ones), either for diagnostic and therapeutic purposes; designing and implementing fully automated manufacturing solutions in aseptic shielded production environment, guaranteeing operator and product safety at the same time.
¦ Strong experience in medical isotopes production processes, either from particle accelerators (Cyclotrons, LINACs) and/or Nuclear Reactors.
¦ Experience in isotopes targets handling equipment (solid, liquid, gas), isotope processing/separation/purification lines and techniques, radiation protection and operator dose reduction, remote handling equipment, automation under radiation environment, full scale testing equipment, mockups, decontamination systems, isotope fractioning, distribution and quality control.
¦ Managed several projects worldwide for 177Lu (carrier added and non) Production and distribution inside cGMP regulated manufacturing dossiers, implementing fully automated design solutions.
¦ Worked and managed project involving sterile production and dispensing / vial filling of 223Ra di-chloride, and other alpha emitting isotopes for radio-ligand-therapeutic applications.
¦ Currently working on several projects involving aseptic manufacturing of theragnostic platforms, involving either alpha & beta emitting isotopes for oncological diseases treatments (225Ac, 228Th, 212Pb, 177Lu, 90Y, 68Ga, 123I etc..).
¦ Member of Nuclear Medicine Europe (NMEU.org) - Innovation / Therapy Group (Aug 2020- Mar 2023).
¦ Electrically and Electronic based safety system risk assessment experience, according to IEC 61508 and IEC 61511.
¦ Joined TEMA Sinergie in April 2023, leading the Sales Engineering Nuclear Medicine Dept. Bringing broad experience in the field and making his expertise available to colleagues, promoting collaboration and communication as well as driving to reach all a “win-win” strategy together with customers and end-users.
¦ Extensive experience in aseptic radiopharmaceuticals manufacturing / fill-finish (sterile filtered and terminally sterilized ones), either for diagnostic and therapeutic purposes; designing and implementing fully automated manufacturing solutions in aseptic shielded production environment, guaranteeing operator and product safety at the same time.
¦ Strong experience in medical isotopes production processes, either from particle accelerators (Cyclotrons, LINACs) and/or Nuclear Reactors.
¦ Experience in isotopes targets handling equipment (solid, liquid, gas), isotope processing/separation/purification lines and techniques, radiation protection and operator dose reduction, remote handling equipment, automation under radiation environment, full scale testing equipment, mockups, decontamination systems, isotope fractioning, distribution and quality control.
¦ Managed several projects worldwide for 177Lu (carrier added and non) Production and distribution inside cGMP regulated manufacturing dossiers, implementing fully automated design solutions.
¦ Worked and managed project involving sterile production and dispensing / vial filling of 223Ra di-chloride, and other alpha emitting isotopes for radio-ligand-therapeutic applications.
¦ Currently working on several projects involving aseptic manufacturing of theragnostic platforms, involving either alpha & beta emitting isotopes for oncological diseases treatments (225Ac, 228Th, 212Pb, 177Lu, 90Y, 68Ga, 123I etc..).
¦ Member of Nuclear Medicine Europe (NMEU.org) - Innovation / Therapy Group (Aug 2020- Mar 2023).
¦ Electrically and Electronic based safety system risk assessment experience, according to IEC 61508 and IEC 61511.
¦ Joined TEMA Sinergie in April 2023, leading the Sales Engineering Nuclear Medicine Dept. Bringing broad experience in the field and making his expertise available to colleagues, promoting collaboration and communication as well as driving to reach all a “win-win” strategy together with customers and end-users.