GMP Grade 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>.
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.