Low endotoxin biomaterials will help reduce animal testing

A new study funded by Rousselot showed that highly purified gelatin can increase the reliability of 3D in-vitro models

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Darling Ingredients’ health brand Rousselot, the global leader in collagen-based solutions, released a new study in collaboration with the University of Twente. The study demonstrated found that the utilization of highly purified gelatin biomaterials for 3D in vitro models can significantly enhance the reliability and reproducibility of these models, creating new possibilities for replacing preclinical animal trials and thus reducing animal testing.

“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 joint study by the University of Twente, The Netherlands, and Rousselot Biomedical investigated for the first time the impact of endotoxins on 3D breast tumor-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).

Low endotoxin biomaterials pave the way for reduced animal testing by increasing the reliability of 3D in-vitro models
The illustration shows how the presence of endotoxins impacts the credibility of 3D models. This figure is a modified version of the original graphic in Heinrich, M. A., Heinrich, L., Ankone, M. J. K., Vergauwen, B., & Prakash, J. (2023). Endotoxin contamination alters macrophage-cancer cell interaction and therapeutic efficacy in pre-clinical 3D in vitro models. Biomaterials advances, 144, 213220.

The study demonstrated that endotoxin levels had a marked effect on the validity of the 3D-printed model in three aspects. The presence of high levels of endotoxins caused a strong inflammatory response in immune cells (macrophages) in contaminated models. Also, on the receptivity of immune cells to cancer cells: crosstalk between macrophages and cancer cells was significantly reduced in the presence of high endotoxin levels. Finally, the high endotoxin environment artificially increased the measured efficacy of the therapy designed to inhibit the expression of anti-inflammatory markers, resulting in greater 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.

Dr Bjorn Vergauwen, Scientific Director, Product and Process Development, Rousselot concluded, “The use of purified biomaterials such as Rousselot’s X-Pure or X-Pure GelMA in in-vitro 3D models is critical in producing a biologically relevant environment, while also helping to reduce the costs, time and ethical concerns associated with drug development.”

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Davide Sher

Since 2002, Davide has built up extensive experience as a technology journalist, market analyst and consultant for the additive manufacturing industry. Born in Milan, Italy, he spent 12 years in the United States, where he completed his studies at SUNY USB. As a journalist covering the tech and videogame industry for over 10 years, he began covering the AM industry in 2013, first as an international journalist and subsequently as a market analyst, focusing on the additive manufacturing industry and relative vertical markets. In 2016 he co-founded London-based VoxelMatters. Today the company publishes the leading news and insights websites and, as well as VoxelMatters Directory, the largest global directory of companies in the additive manufacturing industry.

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