Updated Product Purity Specifications - GMP Cytokines

August 2016

Our GMP cytokines are now characterized based on the recommendations of the upcoming Ph. Eur. monograph 5.2.12

In order to stay up-to-date with the international guidelines for raw materials, we are in constant interaction with regulatory authorities worldwide. In this regard, we amongst others helped defining the European guidelines which are outlined in the new general chapter Ph. Eur. monograph 5.2.12. (effective from January 1, 2017). 

The new chapter outlines guidelines for “Raw Materials of biological origin that are used for the production of cell and gene therapy products”. Included are additional specifications for the product purity of cytokines. 

To comply with these upcoming guidelines, we have updated the specifications for the product purity of our GMP grade cytokines. As a consequence, in addition to host cell DNA and endotoxin also host cell protein (HCP) is analysed for all our GMP grade cytokines. The specification for the HCP content was set to <1µg/mg cytokine, equivalent to 0.1% HCP impurities. Furthermore, product related proteins (i.e. active product variants, including isoforms, oxidized species or oligomeric forms) are specified for each GMP grade cytokine. Please refer to the new data sheets and certificate of analysis for detailed specifications for each individual product.

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