Katzschmann Ines, Marx Heike, Kopka Klaus, Hennrich Ute
German Cancer Research Center (DKFZ), Division of Radiology, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany.
German Cancer Consortium (DKTK), 69120 Heidelberg, Germany.
Pharmaceuticals (Basel). 2021 Feb 25;14(3):188. doi: 10.3390/ph14030188.
For the PET imaging of prostate cancer, radiotracers targeting the prostate-specific membrane antigen (PSMA) are nowadays used in clinical practice. [F]PSMA-1007, a radiopharmaceutical labeled with fluorine-18, has excellent properties for the detection of prostate cancer. Essential for the human use of a radiotracer is its production and quality control under GMP-compliance. For this purpose, all analytical methods have to be validated. [F]PSMA-1007 is easily radiosynthesized in a one-step procedure and isolated using solid phase extraction (SPE) cartridges followed by formulation of a buffered injection solution and for the determination of its chemical and radiochemical purity a robust, fast and reliable quality control method using radio-HPLC is necessary. After development and optimizations overcoming problems in reproducibility, the here described radio-HPLC method fulfills all acceptance criteria-for e.g., specificity, linearity, and accuracy-and is therefore well suited for the routine quality control of [F]PSMA-1007 before release of the radiopharmaceutical. Recently a European Pharmacopeia monograph for [F]PSMA-1007 was published suggesting a different radio-HPLC method for the determination of its chemical and radiochemical purity. Since the here described method has certain advantages, not least of all easier technical implementation, it can be an attractive alternative to the monograph method. The here described method was successfully validated on several radio-HPLC systems in our lab and used for the analysis of more than 60 batches of [F]PSMA-1007. Using this method, the chemical and radiochemical purity of [F]PSMA-1007 can routinely be evaluated assuring patient safety.
对于前列腺癌的正电子发射断层扫描（PET）成像，目前临床实践中使用靶向前列腺特异性膜抗原（PSMA）的放射性示踪剂。[F]PSMA - 1007是一种用氟 - 18标记的放射性药物，在前列腺癌检测方面具有优异的性能。放射性示踪剂用于人体的关键在于其在符合药品生产质量管理规范（GMP）的条件下生产和质量控制。为此，所有分析方法都必须经过验证。[F]PSMA - 1007可通过一步法轻松进行放射性合成，并使用固相萃取（SPE）柱进行分离，随后配制缓冲注射溶液，并且需要一种使用放射性高效液相色谱（radio - HPLC）的稳健、快速且可靠的质量控制方法来测定其化学纯度和放射化学纯度。在克服了重现性问题并经过开发和优化后，本文所述的radio - HPLC方法满足所有验收标准，例如特异性、线性和准确性，因此非常适合在放射性药物放行前对[F]PSMA - 1007进行常规质量控制。最近，欧洲药典发布了一篇关于[F]PSMA - 1007的专论，提出了一种不同的radio - HPLC方法来测定其化学纯度和放射化学纯度。由于本文所述方法具有某些优势，尤其是技术实施更简便，它可以成为专论方法的一个有吸引力的替代方法。本文所述方法已在我们实验室的多个radio - HPLC系统上成功验证，并用于分析60多批次的[F]PSMA - 1007。使用该方法，可以常规评估[F]PSMA - 1007的化学纯度和放射化学纯度，确保患者安全。
