GMP status allows for the ingredient’s use in clinical and in-body applications
Rousselot, Darling Ingredients’ health brand, has announced the launch of GMP-grade, X-Pure GelMA, a gelatin methacryloyl ingredient.
The production of the ingredient under GMP conditions is particularly relevant, the company says, for partners that require GelMA for clinical use and in-body medical applications. The GMP process ensures the product is consistently produced and controlled according to strict quality standards, including consistent chemical modification and purification methods.
X-Pure GelMA has been designed for use throughout the entire product life cycle, Rousselot claims, from early-stage research through to clinical trials and marketed products, it supports a faster route to market by minimising the risk of having to revalidate data.
Kathleen Jacobs, Regulatory Affairs Director at Rousselot Biomedical said: “In less than two years, we developed a research grade as well as an X-Pure GelMA produced under suitable GMP. This marks our commitment to support customer needs. By creating reliable gelatin products with optimal properties and quality, we are helping customers to achieve success.”