cGMP Drug Manufacturing Suite
cGMP Core Laboratory has been designed and equipped to perform the radiolabeling, purification and compounding services for Phase O and I/II clinical trials of new radiotraces. The cGMP manufacturing area consists of 320 sq. ft. All equipment in our cGMP laboratory is compliant with IQ, OQ and Factory Acceptance Tests. Lead-lined, Class II, type A Laminar Flow radiochemistry hood and biosafety cabinets are designated for preparation and purification of clinical grade radiopharmaceuticals. The space includes an independent air handling system and all input air is conditioned using three HEPA filter hood modules; two in the cGMP space and one in the gowning area. These provide an ISO Class M7 or better environment in both the Gowning Area and cGMP Suite. Manufacturing area environment is maintained using HVAC temperature control between 66º F and 84º F and humidity between 15% – 80%. The gowning area includes a sink and emergency shower/eye wash station. Air pressure is monitored with two Sensocon air pressure gauges, one mounted from the circulation hallway into the Gowning area, the second mounted between the gowning area and the cGMP suite. cGMP laboratory is also equipped with 68Ge/68Ga generator, Shimadzu HPLC system with UV and radioactive flow detectors, Bioscan AR-2000 radio-TLC scanner, Isotemp refrigerator and freezer. The cGMP staff maintains resources to the highest technical degree.
On January 11th, 2013, RadioMedix, Inc.’ s cGMP suite has been officially accepted by the FDA and listed in the FDA drug establishment registration database (Number 782281302).
RadioMedix Inc.serves as a co-sponsor and collaborator on the two IND clinical trials for 68Ga-DOTATATE PET-CT scan for diagnosis and staging of neuroendocrine tumors NETs (IND 117289) and 177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms (IND 78,256).