Non-carrier-added GMP-grade radiochemical for clinical and non-clinical research purposes
High purity non-carrier-added Lutetium-177 (Lu-177) Chloride solution in GMP grade for your research activities. The radiochemical solution is used for the preparation of radiolabeled compounds in the research context.
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PLEASE NOTE: The product is not intended for direct use in humans and has not been registered as a pharmaceutical product.
Lutetium-177 is a β-emitter with a half-life of 6.65 days. It can be produced via two different routes, direct by irradiation of Lutetium-176 for carrier-added or as in our case indirect by irradiation of Ytterbium-176 for non-carrier-added (n.c.a.) form. Lu-177 decays by emission of beta radiation (β–: 148.8 keV) and gamma radiation (γ: 208 keV – 10.4 % abundance) to Hafnium-177.
Lutetium-177 has become more and more important over the last years as a substance used in many new radiopharmaceuticals, especially for cancer therapy. In combination with diagnostic [68Ga]-based-agents, it is now the main therapeutic nuclide for theranostic approaches, such as with DOTA-conjugated compounds for binding to the prostate specific membrane antigen (PSMA). Numerous further radiotherapeutic agents are currently under development for several types of cancer.
GMP Quality and Safety Standards
Lutetium-177 Chloride solution is produced in a state-of-the-art GMP production facility. The high purity of our product enables pre-calibration up to ten days. Enhanced vial shielding is used to protect users of unnecessary exposure in accordance with the ALARA principle.
We provide Lu-177 Chloride ([177Lu]LuCI3) as a sterile solution. It is to be used only for in vitro-radiolabeling of carrier molecules. It is not meant for direct application to humans.
U.S. DMF Type II
Eckert & Ziegler holds a Type II DMF (#038043) with the U.S. FDA.
The product has not been registered as a radiopharmaceutical in the European Union. In the USA, it is regarded as a drug substance.
We dispense your required volume of sterile Lutetium-177 Chloride solution up to 3 mL in V-vials or up to 5 mL in a 10R-glass flat bottom vial with activities up to 200 GBq (5.4 Ci)
Production Capacity and Raw Material
Eckert & Ziegler implemented efficient processes and resource allocation measures to ensure uninterrupted production and consistent supply to meet the growing global demand for Lu-177 Chloride (n.c.a.). Moreover, we are currently establishing our own supply of the indispensable precursor material Ytterbium-176, including an efficient recycling process.
A broad international logistics network enables us to deliver Lutetium-177 Chloride worldwide within four business days. Close proximity to international transportation hubs, a global network of partners and the experienced team ensure optimal logistics.
We provide a range of PTB and NIST-traceable Lutetium-177 calibrated solutions. In cooperation with the Eckert & Ziegler Nuclitec we also provide a Lu-177 calibration solution certified by the DAkkS. All our solutions are available on request.
Method and specifications
Lutetium-177 Chloride Solution is produced in high quality non-carrier-added form by irradiation of Ytterbium-176 and subsequent separation of Lu-177 in our radiochemical facility. This process achieves highest purity.
|[177Lu]Lutetium Chloride solution (clear and colorless)
|[177Lu]Lutetium Chloride, 40 GBq/mL
|Hydrochloric Acid (0.04 mol/L)
|[177Lu]LuCl3 in 0.04 mol/L hydrochloric acid solution
|As requested 4 – 200 GBq per vial (activity tolerance ± 10%)
|> 99.0 % [177Lu]Lutetium as Lu3+
|1 – 2
|Within 4 business days worldwide
CDMO Services and GMP Suites
Eckert & Ziegler also provides a wide range of CDMO services, including the development of radiolabeling and quality control protocols for your Lutetium-based products. With our global network of GMP suites (EMEA, AMERICAS, APAC) we give access to state-of-the-art infrastructure including logistics and a highly experienced staff.
Product specific questions?
Eckert & Ziegler