ADCF & Serum-free Policy
Level 1 (cytokine formulation):
No animal-derived components are part of any cytokine product.
Level 2 (cytokine production):
For products designated “ADCF” no animal-derived components are used in any part of the production process. This includes raw materials and materials in contact with the product during production.
Level 3 (production of raw materials for cytokine production):
Whenever possible, only those raw and ancillary materials are used that themselves were produced without use of animal-derived components.
Each medium is free from human or animal serum. The media are optimized for the serum-free culture and maintenance of selected cell types.
If human, but no animal-derived materials are part of the media formulation, the product is designated “xeno-free”.
General Standards for all Products are
Animal-derived components are only accepted in production if they are safe and compliant with TSE guidelines and represent no health hazard. Typically, they are pharmaceutical grade. All materials used in production are formally approved by QM. Their origin and impurity profile are assessed, and only raw materials procured from reliable manufacturers and suppliers are used.
- consistent quality and safety due to state-of-the-art production, stringent quality control and thorough documentation
- reliable high-performance due to our own extensive cell processing know-how
- optimal regulatory compliance based on continuous communication with major regulatory authorities and customers