earticle

영어

The 1st anion exchange chromatography component of the r-hGH manufacturing process was validated in this study, using a validation protocol consistent with both policy and SOP1, 2). Three consecutive lots of crude r-hGH solutions were generated via anion exchange chromatography, which was operated within the operating parameters pre-established via in-process control. For quality control, the buffer solutions employed in 1st anion exchange chromatography were first assessed via tests of pH, endotoxin and bioburden tests. Following 1st anion exchange chromatography, tests for endotoxin, ECP, IEF, Native-PAGE, and protein purity and yield were conducted in order to validate the eluate. All three tested lots satisfied the acceptance criteria pre-established for the following purification process (the 2nd anion exchange chromatography) endotoxin: ≤350 EU/mg; residual host proteins: ≤ 42 ppm; purification yield: 32~36%; purity: ≥ 86%. Therefore, the 1st anion chromatography process was validated in this study, and consistently yields crude r-hGH solutions that fulfill the pre-established criteria for the next purification process.