Based on over 130 years of expertise on gelatin and collagen, Rousselot Biomedical supplies high quality pharmaceutical grade biomaterial for tissue engineering, regenerative medicine, drug delivery systems, cell therapies, surgical and parenteral applications, wound healing and organ on a chip.
Our biomedical business develops purified, modified and non-modified, low endotoxin gelatins and collagens, customized and scaled to a wide range of specifications, for fast, reliable product development.
What makes us different?
We believe in co-development and close collaboration with our customers. We enable our customers to engineer, accelerate and scale up superior biomedical products around the world with our global scientific, technical, and regulatory expertise. Our X-Pure® range of low endotoxin modified, and non-modified gelatins and collagens can be customized to fit customer’s specific needs.
Our collaborative approach supports an end-to-end partnership. From product design to manufacturing, we can help you accelerate the translation of innovative, safe, and stable products, from research to the clinic.
Why is ultra- pure gelatin an essential biomaterial?
Gelatin and collagen are important matrices for cell growth. As natural products with low allergenicity, gelatin and collagen are fully biocompatible with the human body and are particularly useful in biomedical applications such as regenerative medicine, drug delivery, parenteral formulation, and hemostatics. Gelatin has been Generally Recognized as Safe (GRAS) by the US Food and Drug Administration (FDA).
Despite their high biocompatibility, traditionally manufactured gelatins and collagens can contain high levels of endotoxins. Endotoxins are lipopolysaccharides (LPS) from the outer membrane of Gram-negative bacteria and are common environmental contaminants and therefore can also contaminate gelatins. These may induce an inflammatory response, or affect cell growth, differentiation, and function in cell and tissue cultures.
Our research has found that the use of gelatins with uncontrolled LPS content can interfere with cell viability, proliferation, functionality and differentiation, leading to unexpected or irreproducible results. Caution with the use of non-purified gelatins is therefore warranted in the translation from in vitro to in vivo studies. Safety, quality and purity are paramount when biomaterials are used in the body. Due to strict regulations on the levels of endotoxins allowed, the use of a low-endotoxin gelatin is essential.
How our process enables high quality research and patient safety
The X-Pure range supports product safety for patients. Our patented purification process significantly reduces endotoxins (<10 EU/g) in addition to other contaminants such as DNA and residual methacrylic acid, which helps to reduce the risk of immune response. The X-Pure range supports product safety for patients. Our patented purification process significantly reduces endotoxin impurities of our range of purified X-Pure non-modified gelatins (to below 10 EU/g), whilst additionally removing reaction byproducts such as residual methacrylic acid from our X-Pure methacryloyl modified range. These ultra-low impurity levels on the end product come with full control of quality attributes such as gel strength, viscosity, molecular weight, and modification degree (modified gelatins) offering unmet batch-to batch product consistency. X-Pure gelatins and gelMA’s are pharmaceutical grade, produced to a GMP standard and include extensive documentation to ensure traceability, quality, and regulatory compliance data
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