Rousselot Biomedical launches GelMA produced under GMP

Rousselot, Darling Ingredients’ health brand, and the global leader in collagen-based solutions launched its GMP grade GelMA bioink. According to the company, X-Pure GelMA is the first gelatin methacryloyl, or GelMA, on the market to be produced under GMP conditions.

Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. The implementation of such standard in bioink production is another confirmation that the segment is progressively maturing into a more established global market.

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 was presented during the 6th edition of Rousselot’s Innovation Days, which took place on 13th and 14th April 2022 in Ghent, Belgium. This major event for Rousselot takes place every two years, enabling the company’s customers and partners to gain exclusive insights into the latest research in collagen-based innovations. 3D Printing Media Network