描述
CTS™ (Cell Therapy Systems) Vitronectin (VTN-N) Recombinant Human Protein provides a defined surface for feeder-free culture of human pluripotent stem cells (PSCs). When used with Essential 8™ Medium (Cat. No. A1517001), CTS Vitronectin has been proven to maintain pluripotency and normal growth characteristics in multiple PSC lines. In addition, CTS Vitronectin has been shown to support PSC growth for >8 passages without any signs of karyotypic abnormalities and to maintain the ability of PSCs to differentiate into all three germ line lineages. The VTN-N variant of vitronectin supports human pluripotent stem cell attachment and survival better than wild-type vitronectin when used in conjunction with Essential 8 Medium (1).
Features include:
• Designed for clinical research—USP Chapter 1043* considered in the design
• Animal origin–free—for reduced variability and contamination risk in PSC cultures
• Optimized—designed for use with Essential 8 Medium
• Consistent—supports seamless transition from Vitronectin
• Traceable—documentation includes COO, COA, and DMF
• Controlled—manufactured in compliance with ISO-13485:2003
Designed for clinical research
USP Chapter 1043 has been considered in the design of CTS Vitronectin, and this product is the only such product labeled with "For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration to humans or animals." Harmonized documentation is provided with the product and includes a Certificate of Analysis (COA), Certificate of Origin (COO), and Drug Master File (DMF) to support regulatory filings.
Animal origin–free system
CTS Vitronectin is animal origin–free at the primary level to help reduce contamination risk and variability associated with animal-origin raw materials compared to human plasma–derived vitronectin and standard basement membrane extracts (BMEs).
Optimized and defined surface
Unlike standard basement membrane extracts (BMEs), CTS Vitronectin is based on the N-variant design of vitronectin (VTN-N) from the laboratory of James Thomson for use with Essential 8 Medium (1) and has been shown to support human pluripotent stem cell attachment and survival better than wild type vitronectin. CTS Vitronectin provides an optimal environment for feeder-free pluripotent stem cell culture.
Seamless transition from bench to clinic
PSC cultures expanded in other feeder or feeder-free systems can be transitioned to Essential 8 Medium and CTS Vitronectin with minimal adaptation.
Manufacturing control and traceability
CTS Vitronectin is manufactured at a site that is FDA registered and has an ISO13485-certified quality management system. Full traceability documentation such as Certificate of Origin, Certificate of Analysis, and Drug Master File are available.
Commercialized in Partnership with Cellular Dynamics International.
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. Nat Methods. 2011 8(5):424-9.
*U. S. Pharmacopeia. Chapter 1043: Ancillary Materials for Cell, Gene, and Tissue-Engineered Products.
规格
Classification: | Animal Origin-Free |
Product Line: | CTS™ |
Product Size: | 1 mL |
Shipping Condition: | Dry Ice |
内容及储存
Supplied at a concentration of 0.9 mg/mL.
Store at -65 to -85°C.