Gelatin, a widely used biomaterial for pharma and medical applications
Designed by nature, with low allergenicity and fully compatible with the human body, gelatin has been Generally Recognized As Safe (GRAS) by the United States Food and Drug Administration (FDA). Its natural properties and high versatility make it the biomaterial of choice for pharmaceutical and medical applications, including the most demanding ones such as in-body applications where undetectable or very low endotoxin levels are required.
Endotoxins may lead to immune response, even in minute quantities. For in-body applications, Rousselot has developed advanced gelatins with very low-endotoxin levels that can be used in wound healing, injectable fillers and high-end regenerative medicine applications.
The X-Pure range – An unrivalled offer for medical applications
The latest innovation from Rousselot, X-Pure offers unrivalled levels of safety with endotoxin below 100, 20 or 10 Endotoxin Units per gram (EU/g) or even below LAL analysis detection limits(1) if required. The range comprises of different grades of gelatin to exactly match the needs of final medical applications and bring a new level of safety in medical devices for in-body usage.
X-Pure for hemostatic medical devices: the world’s lowest endotoxin levels
Gelatin-based hemostats such as sponges, strips or powder are highly efficient in stopping blood flow. Fast acting, gelatin absorbs at least forty times its own weight. With X-Pure, Rousselot proposes four new gelatin solutions of porcine and bovine origin. With the X-Pure™ 10 P grade in particular, Rousselot launches an exceptionally safe acid porcine skin gelatin that exhibits outstanding foaming properties and unrivalled lows in endotoxin levels.
X-Pure for parenteral formulations: a highly pure, safe and consistent gelatin
For parenteral formulations, Rousselot has developed X-Pure™ 10 HGP, a hydrolyzed gelatin with excellent stabilizing properties. As it is purified by a validated process, manufacturers also benefit from maximum quality consistency. X-Pure™ 10 HGP comes with less than 10 EU/g Endotoxin units, and is the safest choice for parenteral formulations.
X-Pure for regenerative medicine applications: a unique, global one-stop brand of purified gelatins
Used in particular for tissue or stem cell bioengineering, or for the controlled delivery of biomolecules, gelatin mimics the extra-cellular-matrix closely and it is one of the most favorable biomaterials used today. However, for most applications in the regenerative medicine field, biomaterials should exhibit a strict purity and safety profile. In the case of cell culture for example, endotoxins have been shown to have a negative effect on cell growth. To answer the needs of this fast growing and diverse market, Rousselot developed five grades of highly purified gelatins, each of them exhibiting different viscosities, gel strengths and endotoxin levels.
“We are extremely proud to bring the purest gelatins to the medical market and to highly sensitive medical applications. This outstanding, industry-leading product offers unique advantages to assure performance, quality and safety across these areas” comments Tanja Vervust, Global Quality Director, Rousselot, and adds “As the global leader in gelatin production and innovation with a strong R&D team and a world-class laboratory in Ghent, we’re perfectly positioned to support our clients who want to benefit from our new product. We’re looking forward to the Bio International Convention to partner with medical and pharma companies in need of safe and reliable biomaterials.”
Rousselot X-Pure endotoxin levels are determined using Charles River LAL (Limulus Amebocyte lysate) assay, validated for our product. This method provides rapid and reliable results without animal testing and is US FDA compliant.
To find out more, visit X-Pure.com and meet our experts at booth #2838 at the Bio International Convention in Boston from 4 – 7 June 2018. Rousselot’s teams are available to support customers develop specific tailored advanced solutions and help them maximize the use and application of ultra-pure gelatin.
(1) These levels are determined by means of the Charles River LAL (Limulus Amebocyte lysate) assay, an FDA compliant method.