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Official PDF TranslationStem Cell Research & Therapy

A GMP-compliant manufacturing method for Wharton’s jelly-derived mesenchymal stromal cells

Authors: Wanglong Chu; Fen Zhang; Xiuping Zeng; Fangtao He; Guanyan Shang; Tao Guo; Qingfang Wang; Jianfu Wu; Tongjing Li; Zhen Zhong Zhong; Xiao Liang; Junyuan Hu; Muyun Liu

DOI: 10.1186/s13287-024-03725-0Status: Verified Translated Edition
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Key Findings in This Report

• Optimized enzymatic digestion parameters (0.4 PZ U/mL Collagenase NB6, 3 h) significantly increase P0 WJ-MSC yield. • Enzymatic digestion outperforms the explant method in initial outgrowth, and passages 2-5 show superior viability and proliferation. • Successful scale-up from laboratory flasks to pilot-scale cell factories demonstrates GMP-compliant manufacturing feasibility. • Stability studies reveal that multiple freeze-thaw cycles and storage at 20–27°C reduce drug product viability, emphasizing careful handling.