PETNET Solutions is pleased to announce another significant milestone has been reached with the facility receiving regulatory approval to manufacture FDG under the code of Good Manufacturing Practice. This license is granted by the Therapeutic Goods Administration.
This important announcement means PETNET Solutions is one of a limited number of companies with TGA approval for the manufacture of FDG in Australia.
According to General Manager, John Hodder while the facility is one step closer to producing its first commercial batch of FDG there are still two important regulatory steps involving the regulator ARPANSA.
“We are now well underway for approval for the Hot Commissioning License and then subsequently the License to Manufacture from ARPANSA,” explained John. “If all goes well, we should be able to ship product towards the end of November.”
In between these two important steps the PETNET Solutions team has been busy completing the validation batches of product. This means running complete cold commissioning chemistry runs (substituting inactive fluoride for the active component) to get team skills up to scratch for when the facility receives the hot commissioning license.
In total, 11 QC tests are performed within about 20 minutes, so each run requires the most precise planning and execution in the laboratory.
According to John, the results are really encouraging with the analytical specifications well within tolerance.