inflamed pharma GmbH has developed the GMP-compliant synthesis of the chemical precursor DAZAmed (TEoS-DAZA) for the liver-specific PET/CT diagnostic [68Ga]Ga-TEoS-DAZA (PET = positron emission tomography). The validated manufacturing process and the release analytics, based on the Pharm. Eur. Monograph 2902, guarantee consistent product quality. GMP-compliant production and release is confirmed by the GMP certificate of the Thuringian State Office for Consumer Protection (DE_TH_01H_GMP_2024_007). The stability of the precursor is monitored and evaluated by a corresponding stability program in accordance with ICH guideline Q1A. A toxicology study of the chemical precursor according to ICH guideline M3 (R2) shows that it is safe for the intended use. Initial preclinical tests have been carried out at the Department of Nuclear Medicine at Jena University Hospital, and a clinical study is in preparation.

inflamed pharma GmbH offers the precursor to authorized medical professionals.