X-Pure GelMA Purest Modified Gelatin for Translational Medicine
Darling Ingredients' Rousselot introduces new gelatin for 3D bioprinting and more
IRVING, Texas, July 20, 2020 /PRNewswire/ -- Darling Ingredients Inc. (NYSE: DAR), today announced that its Rousselot business, the global leader of collagen-based solutions, has successfully introduced X-Pure® GelMA at Bio Digital 2020. The first Good Manufacturing Practice (GMP)-ready range of gelatin methacryloyl (GelMA) biomaterials suitable for preclinical and clinical applications. X-Pure® GelMA is part of the X-Pure® portfolio of ultra-pure gelatins and collagens, suitable for use as biomaterials in 3D bioprinting, tissue engineering, and regenerative medicine.
In GelMA hydrogels, the most versatile biological environment for cells, the inherent bioactivity, biodegradability, and cell compatibility of gelatin are combined with the ability to tailor photo-crosslinking. This combination holds a huge potential for the creation of tunable biological environments for the culture of various eukaryotic cells at body temperature. Uses for this biomedical technology could be bio-adhesives for patching arteries, transdermal needles for drug delivery or act as a matrix for bone regeneration.
X-Pure® GelMA - The first GMP-ready gelatin methacryloyl. GelMA-oriented patent applications have been growing exponentially over the last five years, with many of these research concepts now being translated into the clinic. However, standard GelMA products often carry high and variable levels of soluble impurities originating from either the gelatin raw material or the chemical synthesis process. The presence of these impurities such as endotoxins, pyrogens and/or methacrylic acid residues are detrimental for in-body use but can also affect the success of in vitro applications. X-Pure® GelMA provides an ultra-pure solution.
"We are pleased that our Rousselot development team has delivered on this exciting new product for the biomedical marketplace," said Randall C. Stuewe, Chairman and Chief Executive Officer of Darling Ingredients. "Rousselot continues to be a global leader of collagen-based solutions for food, biomedical and pharmaceutical sectors."
Rousselot's unique patented two-stage purification process results in ultra-low levels of pyrogens and residual methacrylic acid, providing an excellent safety profile to the product. Further, consistent batch-to-batch quality ensures reliable results and shorter lead times to the clinic.
"Our X-Pure® products are unique on the market, as they come with ultra-low levels of endotoxins and fully validated traceability of raw materials," stated Jos Vervoort, Executive Vice President of Rousselot. "X-Pure® GelMA is our latest addition to our biomedical range of ultra-pure gelatins and collagens and our range will be further extended as we move forward with products bringing added value to the whole biomedical industry."
Readily available, X-Pure® GelMA can be produced in compliance with GMP regulatory requirements for quality, raw material sourcing, and documentation for approval across all major regulators worldwide, thereby minimizing regulatory risks and optimizing the pace of product development. The new range covers a broad choice of molecular weights and modification degrees of gelatin methacryloyl biomaterials, allowing close customer collaboration for custom-made solutions.
Contact Darling Ingredients' Rousselot business to speak to an expert on how X-Pure® GelMA will impact the medical community and further meet the needs of an aging population at www.rousselot.com/biomedical .
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