Method to Development of PET Radiopharmaceutical for Cancer Imaging

Development and Optimization of 11C-Labeled Radiotracers: A Review of the Modern Quality Control Design Process

“…4 Every clinically applied 11 C-tracer must have acceptance parameters and specifications documented that must be met, prior to its use. 13,14 QC tests can be categorized into two categories: pharmaceutical and radioactive. Pharmaceutical tests ensure molecular identity and physiological compatibility and that any microbial or chemical contamination is within acceptable limits.…”

“…1,8 Radioactive concentration or strength of the final product must also be determined. 1,4 A typical timeline for a 11 C-labeled radiopharmaceutical production 9 and an optimized QC timeline, where the longest analysis (the BET in this case) is started first, followed by the other analysis required before the radiotracer can be released and used 13 is shown in Figure 2. The time of the associated QC tests vary from ∼15 min for the BET to as little as ∼30 s for pH measurements.…”

“…Characterization methods refer to analytical methods, such as nuclear magnetic resonance (NMR), that are useful to elucidate the chemical structure of a synthesized compound but are unfeasible to use on every batch of 11 C-tracer produced prior to use. Commonly reported characterization techniques include 1 H and 13 C NMR; mass spectrometry (MS) and highresolution MS (HRMS). A nonradioactive/cold reference standard is characterized thoroughly and is then used as a HPLC-UV -in vivo primate studies 73 73,74 C]UCB-J UCB-J was identified to be a high affinity ligand to Synaptic Vesicle Glycoprotein 2A in the brain.…”

“…Radiopharmaceutical production needs specialized equipment such as a cyclotron, hot cell, radiochemistry module with preparative HPLC, radiation detectors, and a sterile ISO 5 environment . According to Title 21 CFR part 21 and USP 823, facilities, equipment, personnel, and document procedures must ensure a sterile PET product, although its sterility can only be confirmed through inoculated and incubated growth media after it has been used. , The chemical synthesis of a parenterally administered radiotracer may take place in an open or closed system, so that some steps may be performed on a benchtop; however, all activities downstream of the membrane filtration should be conducted in a closed, sterile system to minimize contamination risk .…”

Preliminary PET Imaging of Microtubule-Based PET Radioligand [11C]MPC-6827 in a Nonhuman Primate Model of Alzheimer’s Disease

“…PET (positron emission tomography) is a highly sensitive nuclear imaging technique that uses radioactive ligands to detect and quantify biomarkers in vivo . − Functional PET imaging of MTs using specific radiotracers could help to define MT dysregulation to improve disease diagnosis and treatment monitoring and facilitate the development of novel therapeutics. ,, As Aβ and tau pathologies accumulate in the AD brain, MT integrity is compromised. Therefore, PET imaging of MT-based processes can provide an early indication of neuronal health and brain function prior to the onset of AD symptoms.…”