Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs.
At our US headquarters in Indianapolis, we will be close by to many of our key customers, delivering our products just in time, each day, every day.
Isotopia USA is on a mission to cultivate a Uniquely Better isotope supplier experience for our customers.
We have taken steps to minimize many of the logistics and transportation frustrations, such as eliminating customs border delays, flight weather transportation cancellations, and adding real-time tracking and delivery of our packages among other customer-centric capabilities.
Isotopia has been successfully producing and delivering Lu-177 reliably and cost effectively for over 10 years. We plan on continuing this success and further building on our tradition of customer service excellence in Indianapolis.
This GMP facility will comprise of over 30,000 ft2 of aseptic manufacturing and sterility testing cleanrooms, QC and microbiology laboratories, as well as raw material labs, waste handling facilities, and engineering labs.
Isotopia USA has already received its radioactive material license from the US Nuclear Regulatory Agency and plans to submit its DMF paperwork to the FDA in Q3 2024.
With this accomplishment, we will be able to provide GMP grade Lu-177 nca for customers to qualify with their products during process validation and begin providing commercial scale quantities in Q4, 24.
Ultimately, this state-of-the-art facility will have the capacity to produce for drug labeling well over 200,000 doses per year.
Beyond Lutetium-177, which has become a foundational product for radiopharmaceutical cancer treatments, Isotopia is establishing the capacity to provide other ground-breaking isotope products such as Terbium 161 as well as finished drug products for pre-clinical, clinical and commercial manufacturing applications.
Come discover what Isotopia has to offer you!
