Tech Note: ADCF 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.