All Qkine growth factors and cytokines are manufactured in a dedicated animal-derived component free (ADCF) laboratory
All raw materials used in the manufacture of our growth factors and cytokines are animal-derived component free to the tertiary level of manufacturing, as certified by supplier-provided documentation.
Any raw materials used that are manufactured by fermentation, are considered ADCF if no high or medium infectivity tissues are contained in the culture medium, as specified by the WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies WHO/EMP/QSM/2010.1.
Manufacturing process components
All components of our manufacturing processes are animal-origin free (AOF) to the secondary level, with the exception of a derivatized chromatography matrix used in the purification of the FGF family of growth factors.
This chromatography matrix is manufactured in accordance with cGMP and is extensively characterized by the manufacturer. The components are of therapeutic grade and comply with the European guidance note on minimising 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 it is appropriate for use in our ADCF laboratory and that cytokines produced using this matrix can be considered ADCF but not AOF. The use of this chromatography matrix in our manufacturing process is indicated in the relevant product ADCF status certificates.