Low endotoxin biomaterials could help to reduce animal testing

Gelatin biomaterials

A new study has found that highly purified gelatin biomaterials could enhance the reliability and reproducibility of 3AD in vitro models, creating new possibilities for replacing preclinical animal trials.

The joint study by the University of Twente, The Netherlands, and Rousselot Biomedical investigated for the first time the impact of endotoxins on 3D breast tumour-immune cancer models.

The research compared 3D models using standard gelatins and GelMAs or Rousselot’s X-PURE gelatin and X-PURE GelMA purified biomaterials with low endotoxin levels (<10 EU/g).

“This study revealed that 3D models of novel breast cancer immunotherapies display clear therapeutic efficacy differences depending on the level of endotoxins in gelatins and methacryloyl gelatins (GelMA) used in in vitro systems,” said Dr Kathleen Jacobs, Global Regulatory Affairs Director, Rousselot.

“Biomaterials with low endotoxin content could lead to a more accurate representation of the safety and potency of novel therapeutics. This can improve the validity of 3D in vitro models and help to reduce animal testing.”

The study demonstrated that endotoxin levels had a marked effect on the validity of the 3D-printed model in terms of the inflammatory reaction, the receptivity of immune cells to cancer cells, and reliability of therapeutic outcomes.

Recent changes in European Union and US Food and Drug Administration (FDA) legislation, combined with increased ethical considerations and efficacy demands, are driving the rapid replacement of pre-clinical animal trials with 3D biofabrication models.

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