Rousselot, a global leader in collagen-based solutions, introduced the X-Pure GelMA bioinks at Bio Digital 2020. The first 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.
Methacryloyl is a commonly used crosslinker, important to increase the melting point and mechanical strength of gelatin-based constructs. In GelMA hydrogels, the inherent bioactivity, biodegradability, and cell compatibility of gelatin are combined with the tailorability of 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.
GelMA-oriented patent applications have been growing exponentially over the last 5 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 and/or MA residues are detrimental for in-body use but can also affect the success of in vitro applications.
Rousselot’s unique purification process, centered around a two-stage routine, 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.
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.
“With full and validated traceability of raw materials, and with ultra-low levels of impurities such as pyrogens and methacrylic acid, X-Pure GelMA can significantly reduce time to clinic”, explained Tanja Vervust, Global Director Rousselot Biomedical. “Rousselot’s global presence and biomaterials expertise enable access to an extensive IP portfolio as well as a reliable security of supply, providing real added value to the high purity of the new range.”
The new range covers a broad choice of molecular weights and modification degrees of gelatin methacryloyl biomaterials. This allows close collaboration with customers to determine the right specifications to accurately produce custom-made solutions.