Positron emission tomography/computed tomography (PET/CT-scanning) is becoming the most versatile diagnostic tool for early/metastatic cancer detection as well as an examination of Parkinson and Alzheimer's patients. The project partners TBD-Biodiscovery (Estonia) and PharmIdea (Latvia) have the competences and experience necessary to enter the PET diagnostic market: production of active ingredients and final dosage drug forms.
The aim of the project was to develop technology for the production of the PET precursor for diagnostics. This molecule can be used for the early diagnosis of prostate cancer, one of the most common cancers in men in Europe and worldwide. In addition to early diagnosis, PET prcursor could be used in patient health control for remission (after chemotherapy or radiation therapy) and for the diagnosis of small metastatic tumors in advanced cancer. TBD-Biodiscovery was responsible for the development of the production method and GMP validation, and PharmIdea continued to develop quality control methods and stability studies.
The outcome of the project is the final dosage form of the PET-product with the package of supporting documentation, necessary for its implementation in nuclear medicine centers and hospitals.
Achievements of the project:
- Collection of the market, patent, and scientific data in close cooperation of partners,
- Final selection of PET-product, which has full freedom to operate in the European Union and worldwide and preparation of several intermediates and building blocks for the synthesis of PET precursor,
- Synthesized first samples of the PET-product, used for early diagnostics of prostate cancer, and fully identified structure using modern analytical methods,
- Successful process validation and development of an analytical method for both the PET-product and its drug form,
- Successful technological process development and validation for the production of PET products which can be implemented for routine production in the future,
- Successful compilation of CTD Module 3 documentation,
- Starting and continuing the stability studies, both short term, and long term,
- Organization of the biotech/pharma matchmaking event in Riga (Latvia).
To reach the general public, TBD-Biodiscovery contacted multiple hospitals, science centers, and research facilities and different unions (e.g. cancer societies, doctor societies), in total 200 different facilities were contacted. Also, both partners have actively looked for innovative companies already active in the area of nuclear medicine or developing new products/methods for PET-diagnostics and big pharma companies looking for new products with high added value.