GMP rHu TPO
- CellGenixBrand：
- 1017-050Cat No：
- 50μgSize：
- Add To Cart Quantity：
The choice of your cytokines will influence the result of your ex vivo cell culture substantially. CellGenix®
GMP Cytokines combine a maximum of quality and safety with excellent performance due to our state-of-the art GMP production, quality control, and documentation systems.
The products are manufactured, tested and released in compliance with the relevant GMP guidelines. USP chapter <1043> has been considered in the design of these products. CellGenix®IL-4 is worldwide the first cytokine that complies with USP chapter <92>.
GMP Cytokines combine a maximum of quality and safety with excellent performance due to our state-of-the art GMP production, quality control, and documentation systems.
The products are manufactured, tested and released in compliance with the relevant GMP guidelines. USP chapter <1043> has been considered in the design of these products. CellGenix®IL-4 is worldwide the first cytokine that complies with USP chapter <92>.
Description：
GMP Grade cytokines for Clinical Ex Vivo Use.
Advantages：
Regulatory Compliance
- validated production and QC procedure
- FDA drug master file cross reference available
- animal-derived component free production in E. coli
- frequent facility audits by customers and authorities
Quality controls include
- specific activity (WHO standard)
- sterility (Ph. Eur.)
- endotoxin (Ph. Eur.)
- purity
- identity
- host-cell DNA
- protein content
Documentation
- certificate of analysis (batch-specific)
- drug master file cross reference (on request)
- production sheet (on request)
- product data sheet (as download)
- material safety data sheet (on request)
Storage and Stability：
-20°C or below. Avoid repeated freeze-thaw cycles.
Minimum 6 months from date of shipping.
Store lyophilized cytokine at-20C to-80C.
Store a 100 ug/ml reconstituted cytokine solution:
- 4 weeks at 2C to 8C under sterile conditions after reconstitution. Store in the original container.
- 4 months at-20C to-80C under sterile conditions after reconstitution. Store in 80 ul aliquots in polypropylene cryogenic vials.
Application：
Intended Use
- for clinical ex vivo use
- not intended for human in vivo application
Activity
0.6 x 107 – 7 x 107 IU/mg calibrated with the 1st International Standard NIBSC, # 03/124 . Measured in a cell proliferation assay using a human factor-dependent cell line, MO7e
Dissolution:
Recommend dissolved to store concentration with sterile water (or PBS), add 200ml water to reach the concentration at 250μl/ml is a good idea.
Dilution：
Proposal to diluted with CellGenix®Serum free Media. And please add carrier protein when diluted with sterilewater or PBS, wich prevent product degradation.
Product Literature：
Technical support
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