News | Radiopharmaceuticals and Tracers | April 05, 2024

RLS expands rCDMO capabilities with Eckert and Ziegler's GalliaPharm generators for improved patient diagnostics

Ga-68 has a very short half-life, which presents logistical challenges in distribution

April 5, 2024 — RLS Radiopharmacies, America’s only Joint Commission-accredited radiopharmacy network, today announced it has expanded its radiopharmaceutical contract development and manufacturing (rCDMO) capabilities by entering into a strategic agreement with global isotope technology leader Eckert & Ziegler. Under the partnership, all 31 of RLS’s radiopharmacies will be equipped with Eckert & Ziegler’s advanced GalliaPharm generators, which the radiopharmacy network will utilize to produce high-quality, life-enhancing Gallium-68-based (Ga-68) radiopharmaceuticals. Ga-68 is crucial for Positron Emission Tomography (PET) imaging and plays a pivotal role in the accurate diagnosis and subsequent treatment planning for patients with neuroendocrine tumors and prostate cancer.

“To help meet the ever-increasing demand for precision diagnostics in cancer treatment, we are collaborating with Eckert & Ziegler to place advanced Ga-68 radiolabeling technology into the hands of all our skilled radiopharmacists nationwide," said RLS CEO Stephen Belcher. “A powerful diagnostic isotope, Gallium has an extremely short half-life, necessitating the need for Ga-68-based radiopharmaceuticals to be produced within minutes of patient dosing. By bringing Eckert & Ziegler’s GalliaPharm generators into our network, we are closing the patient care gap in many parts of the U.S. This signifies a major leap forward in our commitment to advancing healthcare and improving patient outcomes through cutting-edge radiopharmaceuticals."

To date, RLS has installed Eckert & Ziegler’s GalliaPharm generators within most of its locations and anticipates the remaining radiopharmacies will be operational by the end of June. All of RLS’s radiopharmacies house cutting-edge clean rooms and are fully equipped and aligned to USP <797>, USP <825> and ISO 14644-1 compliance standards, which guarantees Ga-68-radiolabeled products are produced to the highest standard possible. Additionally, each location is led by experienced nuclear pharmacists, who, along with nuclear technicians, in-house couriers and a robust delivery fleet, ensure every order is meticulously prepared, dispensed and distributed. RLS is also investing in the future by building a national distributed rCDMO network. 80,000 sq. ft. of space across eight of its pharmacies will be used for radiopharmaceutical development, manufacturing and the production of medical isotopes such as Gallium-68, Actinium-225 and Lutetium-177. RLS now offers Ga-68-based radiolabeling, custom compounding, patient dose preparation and last-mile delivery.

"We are pleased to be a trusted partner to RLS in their strategic decision to improve the nationwide supply of the important Ga-68-based diagnostics and to equip their radiopharmacies with our GalliaPharm," said Jay Simon, managing director of Eckert & Ziegler Radiopharma, Inc. "The demand for radiopharmaceuticals continues to grow in the U.S. and around the world, with many promising drugs in clinical trials. As the number of products increases, the flexibility that our generator provides in the production of Ga-68 will be an even greater asset than before."

Ga-68 from GalliaPharm generators is used in the preparation of radiodiagnostics for neuroendocrine tumors and prostate cancer (Ga-68-PSMA) in countries all around the world. The generator offers a low-cost alternative for the radiolabeling of biomolecules with Gallium-68 in PET, an imaging examination method used to detect the presence or absence of diseased tissue. PET Imaging is primarily used in the diagnosis of cancer, heart attacks or neurological diseases. Radioisotopes such as Fluorine-18 can be used alternatively but require investments of millions of dollars in large-scale equipment (cyclotrons). The Ge-68/Ga-68 generator on the other hand, is an easily transportable, small metal box and can be obtained much more cost-efficient, leading to cost reductions in nuclear medicine clinics and practices while increasing flexibility.

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