Rousselot Biomedical gelatins: The fast track to market
A strategic business segment within Rousselot® – the world-leading manufacturer of gelatin and collagen-derived solutions – Rousselot Biomedical has drawn upon 130 years of worldwide expertise and proven track record of pharmaceutical gelatins and collagens to develop innovative ranges of purified, modified, and non-modified gelatins for biomedical applications. We assist medical device, ATMP & pharmaceutical manufacturers in creating new, safe, and effective medical products, by helping them bridge the gap between research and clinical success.
X-Pure: A world-class range of customizable low-endotoxin gelatins for in vitro and in vivo applications
Our X-Pure® range of ultra-pure, low endotoxin gelatins (<10 EU/g)—over 100 times lower than traditional gelatins— are fully MDR ready and ISO 22442 compliant, ensuring customers products meet the highest regulatory standards, providing a fast track to market for medical devices.
The range comprises various gelatins and modified gelatins, namely X-Pure, X-Pure GelMA, and X-Pure GelDAT. X-Pure GelMA is the world’s first gelatin methacryloyl produced under GMP conditions.
The ultra-purified and modified gelatins within the X-Pure range are used in FDA approved embolizing agents, hemostats, drug delivery devices, anti-adhesion solutions and many more applications.
Quali-Pure® range of pharmaceutical gelatins
Specifically designed to support biomedical application areas including embolization, wound healing, drug delivery, vaccines and hemostatics, Quali-Pure delivers biocompatibility, biodegradability, controlled endotoxin levels, and batch-to-batch consistency.
All Rousselot biomedical gelatins are GMP* ready and fully documented to support medical device compliance with ISO standards and the new EU Medical Device Regulation (MDR). Rousselot’s research and GMP grades are functionally equivalent, streamlining the transition from research to clinical trials by minimizing the necessity for data revalidation.
Rousselot Biomedical is committed to engineering, accelerating and scaling superior products to help transform ideas into biomedical solutions worldwide, using our scientific expertise and collaborative approach to support end-to-end partnerships and improve patients’ lives.