IBA Molecular North America, a manufacturer and distributor of PET imaging tracers, has introduced its two centers for innovation, designed for radiopharmaceutical contract development and manufacturing. The centers are located in Totowa and Somerset, N.J.
These sites will be used for IBA Molecular's production capabilities for isotopes, such as I-124, F-18, Zr-89 and, in the future, Cu-64 and Y-86. The centers are expected to play an role in the development of a new disease-specific tracers and companion theragnostics, according to the Louvain-la-Neuve, Belgium-based company.
The primary site is a radiopharmaceutical facility in Totowa, N.J. The 8,500 square-foot research and development center is staffed by radiochemists, nuclear pharmacists, quality control chemists and cyclotron engineers. The staff will be working on radio-labeling, product development and industrialization of new tracers, technology transfer and good manufacturing practices (GMP) production of doses for clinical trials.
Undertaking both large (mAbs, proteins) and small molecule radio-labeling research, the center will seek to develop processes to support new tracers including those that utilize isotopes, such as F-18, I-124 and Zr-89. The company noted that these endeavors are geared toward supporting human clinical trials of novel tracers.
Specifically, these GMP-validated sites provide capabilities, including:
- Compounding of I-124 capsules for clinical use;
- Producing the purity I-124 available under a DMF for this radioisotope;
- Production of new tracers integral to preclinical translational research;
- Infrastructure and investigational products for varied phases of clinical studies;
- Production of new tracers for hybrid-probe development; and
- Infrastructure capable of supporting targetry for research isotope production including Cu-64, Y-86 and other isotopes.
IBA Molecular has development and manufacturing partnerships with pharmaceutical firms, including Wilex, Aposense and Piramal Imaging.