Rousselot, Darling Ingredients’ health brand, has launched Quali-Pure HGP 2000, an endotoxin-controlled, pharmaceutical-grade gelatin designed for vaccines and wound healing applications. The non-gelling hydrolysed gelatin further extends the scope of biomedical applications covered by Rousselot’s products.
Gelatin, in its non-gelling hydrolysed form, is used as a protein or peptide excipient in vaccine formulations due to its natural biocompatibility and biodegradability and its ability to stabilise vaccines. When used in wound healing, gelatin has reportedly been shown to stimulate the migration of cells, particularly fibroblasts, to the wound site and to promote the formation of tissue.
Quali-Pure HGP 2000 not only exhibits the functionalities for these biomedical applications, but it also comes with the additional benefits of controlled endotoxin levels and enhanced regulatory compliance, Rousselot says.
The product is part of the company’s recently launched Quali-Pure range. All products within the range offer controlled endotoxin levels and batch-to-batch consistency. They meet stringent quality and safety standards and are compliant to ISO 22442-2 and 22442-3, as well as IPEC GMP. They also support the EU Medical Device Regulation (MDR) 2017/745.
Kathleen Jacobs, Global Regulatory Affairs Director at Rousselot Biomedical said: “We are very proud to bring this new product to the market. With Quali-Pure HGP 2000, pharmaceutical manufacturers are not only choosing quality, safety and consistency, but they can also achieve peace of mind knowing that all our biomedical gelatins are compliant with the more stringent regulations coming in force.”