生产控制和可追溯性 CTS 玻连蛋白的生产工厂使用符合医疗器械 cGMP 21 CFR 第820部分的方法和质控措施。我们的 FDA 注册生产工厂通过了 ISO 13485 和 ISO 9001 认证。––提供完整的可追溯性文件,包括原产地证书和检验报告。
与 Cellular Dynamics International 合作实现商业化。
1.Chen G, Gulbranson DR, Hou Z, Bolin JM, Ruotti V, Probasco MD, Smuga-Otto K, Howden SE, Diol NR, Propson NE, Wagner R, Lee GO, Antosiewicz-Bourget J, Teng JM, Thomson JA.Chemically defined conditions for human iPSC derivation and culture.Nat Methods.2011 May;8(5):424-9.
*U. S. Pharmacopeia.Chapter 1043: Ancillary materials for cell, gene, and tissue-engineered products. **European Pharmacopeia.Chapter 5.2.12: Raw materials of biological origin for the production of cell-based and gene therapy medicinal products.
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.
规格
浓度
0.81–0.99 mg/mL
适用于(应用)
Cell and Gene Therapy Research, Development, and Manufacturing