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GMP rHu IL-15
  • CellGenixBrand:
  • 1013-050Cat No:
  • 50μgSize:
  • Add To Cart Quantity:

GMP  rHu IL-15

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>.

Description:

GMP rHu IL-15,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. 
   Avoid repeated freeze/thaw cycles.


Application:

Intended Use

  • for clinical ex vivo use
  • not intended for human in vivo application

Activity

0.75x107-3x107 IU/mg calibrated with the 1st International Standard NIBSC, # 95/554 .Measured in a cell proliferation assay using an IL-15-dependent cell line, CTLL-2 

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:

download

Technical support

There are questions about GMP rHu IL-15? Click the link below to enter the FAQ, supporting documents, or directly to Contact Us After-sale Service Manual for you to answer your question.