Do the GMP-grade K562 feeder cells comply with ICH quality standards?

Yes. All testing methods and quality control systems Hillgene's K562 feeder cells are developed and validated in accordance with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) standards. This includes cell characterization, release criteria establishment, stability studies, and process validation, ensuring that the data are suitable for global regulatory submissions, including FDA, EMA, and CDE filings.

For more information: Genetically Modified K562 Feeder Cell - Hillgene Biopharma Co., Ltd.