Lu-177 n.c.a. – Full GMP

The use of no-carrier-added (n. c. a.) 177Lu is excellent for the efficacy and quality of therapeutic radiopharmaceuticals. The production route of ITG’s 177Lu takes advantage of highly enriched Ytterbium-176 as starting material, thereby providing the highest specific activity and an unprecedented level of radionuclidic purity.
Using 177Lu in its pure form enables the specific radioactivity to be greatly increased by up to 6-times. As a result, the superior performance creates favorable preconditions for efficient radiolabeling of biomolecules such as peptides and antibodies.

With us, you can choose your day of Activity Reference Time (ART) at one of 7 days within shelf life, right according to your needs.Through our reliable, longstanding partnerships with nuclear reactors we can guarantee security of supply and daily availability of 177Lu 365 days a year.  ITG strive for excellence in establishing an innovative, fully-integrated n. c. a. 177Lu platform, setting new standards. ITG’s 177Lu is GMP certified and received EU Marketing Authorization.

ITG’s Lu-177 n.c.a. (no carrier added, i.e. very pure – currently the only one commercially available in GMP world-wide) is produced by irradiating high-enriched Yb-176 leading to excellent characteristics:

  • EU Marketing Authorization

  • GMP certification

  • Highest specific activity at ART ≥ 3,000 GBq/mg

  • Cost effective and environmentally
    sustainable waste management

  • No contamination with long-lived 177mLu

  • High security of supply via backup contracts with >10 reactors worldwide
  • Availability – 365 days a year

  • Choose the day of ART according to
    your needs

  • Sterile / Endotoxin-tested

ITG

With ITG’s Lu-177 n.c.a., because of its outstanding specific activity and high purity, the amount of peptide or antibodies used for labeling can be reduced by 50% or more. Additionally a high radiolabeling yield can be achieved even 11 days after post-calibration time (of course there is decay based on the half-life of 6.65 days). In the Lu-177 n.c.a. 4 out of 5 Lutetium atoms are radioactive. In the Lu-177 c.a. it is the opposite: Only 1 out of 5 atoms is radioactive. This is the reason for the much higher specific activity of our Lu-177 n.c.a.

The Lu-177 that can be bought from other suppliers is always carrier added Lu-177 (c.a.) with poor specific activity and poor radionuclide (radioisomeric) purity. It can’t be avoided due to production route. A minimum of 0.1% of the activity of the Lu-177 c.a. is the long-lived (160 days half-life) Lu-177m isomer. It is going into the patients together with the wanted short lived Lu-177 isomer. This isomer can’t be found in our Lu-177 n.c.a.

Besides injecting long lived nuclide into patients, also waste disposal problems are caused by this long lived isomer. The waste problem of which very few customers were or are aware has made a lot of European hospitals convert to our Lu-177 n.c.a. as hospitals risk that all of their decay tanks get blocked with the long-lived Lu-177m isomer which you only find in carrier added Lu-177. To give you two recent examples: One customer had to close down his radioiodine therapy unit for three weeks because of blockage of his decay tanks with Lu-177m. Another customer had to empty his decay tanks for an amount in excess of 100,000 EUR to get rid of his waste because of Lu-177m. It is the same with all solid material used for the handling: it stays contaminated for years. Not so with our Lu-177 n.c.a.!

Because of our worldwide network of irradiating reactors (>10) we can deliver Lu-177 n.c.a. every weekday from Monday thru Friday in 52 weeks per year. We ship our Lu-177 n.c.a. world-wide.

NO-CARRIER-ADDED VS. CARRIER-ADDED 177Lu :

  • Showing superior characteristics when compared to the carrier-added radioisotope
  • The specific activity of n. c. a. 177Lu is up to 6 times higher than of the c. a. isotope.
  • Due to its slower decrease of specific activity EndolucinBeta® offers favorable preconditions for an efficient
    radiolabeling reaction over its entire shelf-life of 9 days after production.
  • No-carrier added 177Lu provides the highest achievable radionuclidic purity. ITG’s 177Lu, In comparison to the c.a. isotope,  contains no metastable 177mLu and does not require any costly logistics and storage of contaminated radioactive waste.
Download 177Lu Brochure here (PDF)
Lu-177 Order Form Radiomedix