Precision Medicine

With radiopharmacy against rare tumors

In Germany alone, there are four million people with rare diseases

Getting a precision radioactive drug in the right dose to the right place at the right time requires an incredibly complex production and logistics chain. We developed the software for logistics and production for a radiopharmaceutical company of the Isotope Technologien München AG (ITM).

Solucin is an active ingredient that the pharmaceutical industry processes in precision medicine against so-called GEP tumors. For example, an oncologist in Los Angeles prescribes treatment with Solucin for a patient. A highly complex production process is then started: The pharmaceutical company procures radioactive material and must be able to provide complete proof at all times of how much was used, when and for what purpose.

The finished drug is elaborately packaged and labelled. A glass container, a lead container, a polystyrene box and a cardboard box each receive a label with precise, individual information. Each label must also be archived in such a way that the US regulatory authority FDA (Food and Drug Administration) can trace everything exactly.

Before the batches are picked up, the driver is carefully checked. At national borders (for example, when the medicine goes to Italy) another driver with the nationality of the country takes over the delivery. The radioactive transport must also be announced in advance to the airlines.

For the doctor to be able to treat his patient, he needs the right radioactive dose on the right day. If he does not use it all, the rest must be safely disposed of and documented for the authorities. We have developed the software for ITM for this entire process (starting from the receipt of the order)

Currently 42 cancer centers in 12 countries, mainly in Europe, the USA, South Africa and Australia, are participating in the clinical study (Phase III) - we hope that the drug will then also be approved in the USA.

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