September 14, 2012 — IBA Molecular North America Inc., a manufacturer and distributor of PET imaging tracers, has announced the introduction of its Centers for Innovation, two unique facilities designed for advanced radiopharmaceutical contract development and manufacturing. The centers are located in Totowa and Somerset, N.J. Complementing these sites are 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 important role in the development of a new generation of disease-specific tracers and companion theragnostics.
The primary site is a state-of-the-art radiopharmaceutical facility in Totowa, N.J. This fully equipped 8,500-square-foot research and development center is staffed by a team of accomplished professionals, including radiochemists, nuclear pharmacists, QC chemists and cyclotron engineers. The staff has expertise in radio-labeling, product development and industrialization of new tracers, technology transfer and GMP production of doses for clinical trials. These attributes make the site an ideal destination for collaborative projects. With both large (mAbs, proteins, etc.) and small molecule radio-labeling expertise, the center can develop processes to support almost any new tracer, including those that utilize isotopes such as F-18, I-124 and Zr-89. All of these endeavors are geared toward supporting human clinical trials of novel tracers.
These GMP-validated sites provide a broad range of capabilities, including:
- Compounding of I-124 capsules for clinical use
- Producing the highest purity I-124 available under a DMF for this radioisotope
- Production of novel tracers integral to preclinical translational research
- Scalable infrastructure and investigational products for all phases of clinical studies
- Production of novel tracers integral to hybrid-probe development
- A supporting resource or "think-tank" for development and industrialization
- Scalable infrastructure capable of supporting solid targetry for research isotope production including Cu-64, Y-86 and other isotopes
"The molecular imaging industry needs an accelerant to drive innovation and new products. Our specialized knowledge and outstanding facilities in radiopharmaceutical development and manufacturing are at the disposal of our partners and will undoubtedly assist in bringing new products to the market faster," said Lee Karras, president of IBA Molecular North America Inc. "These Centers for Innovation will provide researchers, pharma and biotech companies with access to our unmatched expertise in small and large molecules, as well as our proven track record with the development of novel tracers. Standing alongside these centers is IBA Molecular's global commercial network of nuclear pharmacies, which will be paramount to the successful launch of any new, commercialized tracer."
IBA Molecular has development and manufacturing partnerships with a number of pharmaceutical firms, including Wilex, Aposense and Piramal Imaging, as well as ongoing research collaborations with noted medical institutions throughout the U.S. and Europe.
For more information: www.iba-molecular.com