Rousselot, Darling Ingredients’ health brand and the global leader of collagen-based solutions1, launched Quali-Pure HGP 2000, a new endotoxin-controlled, pharmaceutical-grade gelatin specifically designed for vaccines and wound healing applications. As the latest addition to Rousselot Biomedical’s rapidly expanding product offering, this new non-gelling hydrolyzed gelatin further extends the scope of biomedical applications covered by Rousselot products.
Quali-Pure HGP 2000 for vaccines and wound healing
Gelatin, in its non-gelling hydrolyzed form, has long been used as a protein or peptide excipient in vaccine formulations due to its natural biocompatibility and biodegradability and its ability to stabilize vaccines. When used in wound healing, gelatin has been shown to stimulate the migration of cells, particularly fibroblasts, to the wound site and to promote the formation of new tissue.
Quali-Pure HGP 2000 not only has the optimal functionalities for these biomedical applications, but it also comes with the additional benefits of controlled endotoxin levels and enhanced regulatory compliance, setting it apart from similar products on the market.
Expanding the Quali-Pure range
The new Quali-Pure HGP 2000 is part of the recently launched Quali-Pure range. All products within this range offer controlled endotoxin levels and batch-to-batch consistency. They meet stringent quality and safety standards and offer full and documented traceability up to the farm (ISO 22442-2), validated viral inactivation (ISO 22442-3) and IPEC GMP compliance. They also support the new EU Medical Device Regulation (MDR) 2017/745 which must be fully implemented by May 2024.
According to Kathleen Jacobs, Global Regulatory Affairs Director at Rousselot Biomedical, “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.”
1. Global Gelatin Market Insights Forecast to 2026 Calibre Research, 2020