Rousselot® Biomedical, Darling Ingredients' brand, announces the world's first GelMA produced under GMP
Darling Ingredients Inc. (NYSE: DAR) announced the launch of X-Pure GelMA, the first gelatin methacryloyl produced under Good Manufacturing Practices (GMP). This product marks a significant advancement for clinical use in medical applications, shifting from research-grade options to GMP-compliant products. The consistency and quality assured by the GMP process support faster market entry with minimized revalidation risk. This announcement coincided with Rousselot's Innovation Days event in Belgium on April 13-14, 2022.
- Launch of X-Pure GelMA under GMP conditions enhances clinical application opportunities.
- Product ensures batch-to-batch consistency and quality control.
- Accelerates route to market for clients by reducing revalidation risks.
- None.
IRVING, Texas, April 13, 2022 /PRNewswire/ --Darling Ingredients Inc. (NYSE: DAR) today announced that it's health brand Rousselot®, the global leader of collagen-based solutions1, launched GMP grade GelMA. X-Pure® GelMA is the first gelatin methacryloyl, or GelMA, on the market to be produced under GMP conditions2.
The production of X-Pure GelMA under GMP conditions is a major step forward for companies that require GelMA for clinical use and in body medical applications. Up until now, research grade GelMA was the only available option. The GMP process ensures that Rousselot X-pure GelMAs are consistently produced and controlled according to strict quality standards, including consistent chemical modification and purification methods.
Because X-Pure GelMA has been designed for use throughout the entire product life cycle, from early-stage research through to clinical trials and marketed products, it supports a faster route to market by minimizing the risk of having to revalidate data. Batch-to-batch consistency and quality is guaranteed at any scale.
"We are proud to be the first in the market to offer GelMA produced under GMP," says Kathleen Jacobs (PhD), Regulatory Affairs Director at Rousselot Biomedical. "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."
Research grade X-Pure GelMA was launched in June 2020 as a premium alternative to standard research grade GelMAs. It offers ultra-low impurity levels (including endotoxins, methacrylic acid and DNA), batch-to-batch consistency and tunable mechanical properties. It is ideal for a wide range of in vitro and in vivo research and development applications, particularly regenerative medicine applications such as tissue engineering, 3D bioprinting and 3D cell culture.
The product launch is being announced at the 6th edition of Rousselot's Innovation Days, which are taking place on 13th and 14th April 2022 in Ghent, Belgium. This major event for Rousselot takes place every two years, enabling our customers and partners to gain exclusive insights into the latest research in collagen-based innovations.
To find out more about Rousselot Biomedical and X-Pure GelMA, please visit our website: www.rousselot.com/biomedical
References:
1. Global Gelatin Market Insights Forecast to 2026 Calibre Research, 2020
2. IPEC PQG Good Manufacturing Guide for pharmaceutical excipients (2017)
About Darling
Darling Ingredients Inc. (NYSE: DAR) is a world leading producer of organic ingredients, generating a wide array of sustainable protein and fat products while being one of the largest producers of renewable clean energy. With operations on five continents, Darling collects waste streams from the agri-food industry, repurposing into specialty ingredients, such as hydrolyzed collagen, edible and feed-grade fats, animal proteins and meals, plasma, pet food ingredients, fuel feedstocks, and green bioenergy. Darling Ingredients named one of the 50 Sustainability and Climate Leaders in 2021, to learn more Darling Ingredients: The greenest Company on the planet - 50 Sustainability & Climate Leaders (50climateleaders.com). The Company sells its ingredients around the globe and works to strengthen our promise for a better tomorrow, creating product applications for health, nutrients and bioenergy while optimizing our services to the food chain. Darling is a
Rousselot® Biomedical
As the most recent strategic segment within Rousselot, we have drawn upon Rousselot's 130+ years of worldwide expertise and proven track record of pharmaceutical gelatins and collagens to develop innovative ranges of purified, modified and non-modified gelatins and collagens for biomedical applications. Offering unique advantages to assure performance, quality and safety from bench to clinic, Rousselot® X-Pure® and Rousselot® Quali-Pure™ provide consistent quality and are backed by strong scientific data and on-going research. Rousselot Biomedical is committed to support end-to-end partnerships to help "Advancing medical science". https://www.rousselot.com/biomedical
Rousselot
Caroline Brochard-Garnier
Director of Communications & PR, Rousselot
E: caroline.brochard-garnier@rousselot.com
Sciad Communications
Maria Patey / Sophie Protheroe
E: rousselot@sciad.com
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VP, Investor Relations, Sustainability & Communications
(469) 214-8202
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SOURCE Darling Ingredients Inc.
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