Written for practitioners in nuclear medicine, this publication from the International Atomic Energy Agency provides guidance on the safe and effective use of radiolabelled monoclonal antibodies and peptides which bind to cell surface rectors and address aberrant cellular function or those overexpressed in certain diseases.
Jozsef Repasi, Managing Director of Ubichem Research commented: This approval enables us to supply radiolabelled materials for use in human clinical trials, and is a reflection of the skill and hard work of our dedicated team in Budapest, building on the approval obtained previously for the commercial supply of cGMP APIs.
Director of Business Development for Radiochemistry, Dave Roberts added: "By selecting Selcia for the preparation of their 14C GMP radiolabelled APIs, clients have the widest choice of phase 1 clinics for their human clinical trials.
The OMP designation has been granted on the basis that: follicular lymphoma affects fewer than 5 in 10,000 persons in the European Community; the condition is serious and life-threatening; although satisfactory methods of treatment have been authorized in Europe, tositumomab and Iodine I 131 radiolabelled tositumomab may be of significant benefit to those affected by the condition.
This affinity, combined with NeoTect's radiolabelled technetium-99m, a safe and inexpensive radioisotope imaged through widely available gamma camera systems, allowed clinicians in the study to precisely distinguish the malignant versus the nonmalignant small tumors.