Cytokines – Animal-Derived Component-Free Policy
We follow a strict animal-derived component-free (ADCF) policy to ensure maximum safety of our preclinical and GMP cytokines. As a result no animal or human-derived components are part of any of our cytokine products.
The large majority of our cytokines is produced in our dedicated animal-free facility (ADCF Level 2). These cytokines have never been exposed to animal components or byproducts. They can therefore be safely used without the need to perform time-consuming and expensive viral safety studies, thereby bringing a significant economic benefit.
Those very few cytokines produced in our 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.
Raw Material Control
We apply a strict raw material control for all raw materials used in the production process of our ADCF Level 2 & 1 cytokines. All materials used are formally approved by our quality management (QM).
As part of our raw material control they are procured from reliable manufacturers and suppliers. Their origin and impurity profile are assessed before use and are demonstrated by documented evidence of viral/prion safety. Whenever possible, raw materials are used that themselves were produced without the use of ADC.
Media – Serum-Free Policy
We follow a strict serum-free policy for our cell culture media, meaning that all media are produced without the addition of human or animal serum.
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 and their animal- or human origin is assessed before use. A material is only accepted if it represents no apparent health hazard and is compliant with the relevant regulatory guidelines.
Our products are designated “xeno-free” as human-, but no animal-derived materials are part of the media formulation.
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