All Qkine growth factors and cytokines are manufactured in a dedicated animal-derived component free (ADCF) laboratory.
The majority of our proteins do not contain and are never exposed to animal components during the manufacture process.
Some cytokines require the use of ADC in the production process, specifically a heparin-derivatized chromatography matrix (Heparin Sepharose 6 Fast Flow). This matrix is sourced from GE Healthcare and extensively characterized by the manufacturer. The heparin sulfate ligand is of porcine origin and is therapeutic grade and manufactured in accordance with cGMP. The chromatography matrix complies with European guideline “Minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01-Rev 3)”.
Following review of the regulatory support file for this matrix, we have concluded that this is appropriate for use in our ADCF laboratory and that cytokines produced using this matrix can be considered ADCF. Products where this matrix is used in the manufacture are indicated on the online datasheet.
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