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EU24CEMAR1/SES307 - Automated Radiopharmaceutical Fill-Finish Line Challenges

‐ Mar 12, 2024 3:00pm

The new frontier of cancer treatment is Theranostic. A new word coupling the terms THERApeutic and diagnNOSTIC.

In the last years, coming from the expertise developed on molecular imaging/PET/SPECT tracers, new drugs have been developed to treat different kind of tumors, mainly the ones which do not respond to conventional oncological treatments. Most of these drugs are belong to the family of  “RLT” – Radio Ligand Therapies, where a carrier (ligand) is used to transport a radioactive isotope with therapeutic (killing) purposes to a neoplastic cell with extreme precision. The same or similar ligand can be also linked to a different isotope (called diagnostic pair) with imaging properties, to monitor the progress of the treatment using PET/SPECT examinations.

The FDA/EMA approval in the last years of these RLT drugs for routine therapy, created a new demand of aseptic fill-finish and inspection lines with larger production capabilities,  able to guarantee the radioprotection and safety of the personnel as well as the sterility of the product.

Purpose of the presentation is to show a real case study highlighting the design and operational challenges in the development of such shielded aseptic isolator suite for a fill finish and inspection line, able to match regulatory, radioprotection and customer requirements.