ADCF and Serum-free Policy
Ancillary materials derived from biological origin can introduce risks to the process and final ATMP product, including transmission of viruses.
Using animal-derived component-free cytokines:
- Ensures maximum safety of the ATMP, no animal or human-derived components are part of any of our cytokine products.
- Reduces variables associated with animal-derived components.
- Makes time-consuming and expensive viral safety studies obsolete, thereby bringing a significant economic benefit.
The large majority of our cytokines is produced in a dedicated animal-free facility (ADCF Level 2). These cytokines have never been exposed to animal components or byproducts. Very few cytokines produced in the segregated animal-derived components (ADC) production area require either the use of ADC in the production process or a human expression system to allow proper functional expression (ADCF Level 1). To ensure maximum safety we provide documented evidence of viral and prion safety.
All CellGenix® media are produced without the addition of human or animal serum. CellGenix® products are designated “xeno-free” as human, but no animal-derived materials are part of the media formulation. All samples were tested individually and found negative for viral diseases by approved methods.
Using serum-free media:
- Ensures maximum safety of the ATMP, no animal-derived components are part of any of our media products
- Reduces variables associated with animal-derived components.
All materials used in production are formally approved by our QM. As part of the raw material control they are procured from reliable manufacturers and suppliers. A material is only accepted if it represents no apparent health hazard and is compliant with the relevant regulatory guidelines.
