CellGro® GMP Cytokines for Clinical Ex Vivo Use


The choice of your cytokines will influence the result of your ex vivo cell culture substantially. CellGro® 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. CellGro® IL-4 is worldwide the first cytokine that complies with USP chapter <92>.

CellGro® GMP Cytokines

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

Intended Use

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

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)
 

CellGenix offers a comprehensive, growing portfolio of CellGro® GMP Cytokines for clinical ex vivo culture a broad set of cell types. Our complete product list is availabe as download.