Radiopharmaceutical Manufacturing: Connecting science, process and regulations

Abstract: The manufacturing process of radiopharmaceuticals is uniquely complex, requiring rapid synthesis, aseptic handling, and real-time quality control under strict GMP conditions. This talk will outline the key stages of production—from radionuclide generation and radiolabelling, to formulation and release testing. Regulatory frameworks will be discussed, highlighting common principles of compliance. The talk aims to provide a concise overview of how scientific innovation and regulatory standards work together to ensure safe & timely delivery of nuclear medicine to patients.

Bio: Saikat is a clinical radiochemist & preclinical radiobiologist with expertise in analytical method development and product quality control. During his PhD with GlyTherix and Prof Kristofer Thurecht (UQ), he was instrumental in developing and preclinically trialling Antibody Radiation Conjugates to target Glioblastoma. Saikat has also served as a Research Officer in Prof John Hooper’s group at the Mater Research Institute. Saikat was previously employed as an Industry Postdoctoral Scientist at the AMTAR Research Hub, UQ, where he collaborated with Telix Pharmaceuticals in targeted theranostics projects of clinical and commercial interest

Saikat is presently employed as a Senior Radiochemist with Quantum Pharma Australia, based at St Vincent’s Hospital, Sydney. He is currently responsible for manufacturing patient doses of both approved and investigational radiopharmaceuticals, while also serving as a technical lead for selected client projects.