Our new GMP-ready X-Pure Gelatin Methacryloyl (also known as GelMA or methacrylated gelatin) will support even your most demanding research and clinical challenges. It comes with full and validated traceability of raw materials, and guaranteed ultra-low levels of impurities, such as pyrogens and methacrylic acid. This pharma grade gelatin methacryloyl enables you to significantly reduce the time to clinic, even for the most regulatory demanding Pharmaceutical, Medical Device, Advanced therapy medicinal products (EU) / Cell & Gene Therapy products (US).
We work in close collaboration with our customers to determine the right product specifications and properties and produce custom made solutions.
The X-Pure GelMA range of gelatin methacryloyl or methacrylated gelatin biomaterials offers numerous benefits over alternatives for superior product solutions and faster time to market.
- Readily available
- Appropriate for research and clinical applications
- Consistent manufacturing process and product properties
- All documentation available for filings
- Suitable for even the most restrictive applications
- Consistent batch-to-batch quality
- Ultra-low levels of pyrogens safeguarding cellular studies and clinical applications
- Ultra-low levels of residual methacrylic acid ensuring consistent gel mechanical behavior, and safety
- Tailored, controlled and consistent mechanical properties
- Full traceability from raw materials to final product
- Leverage of Rousselot’s global presence and expertise in biomaterials:
- Reliability and security of supply
- Leverage of Rousselot’s IP portfolio, potentially on an exclusive basis for your application
- Access to world-leading expertise in biomaterials
X-Pure GelMA is produced meeting regulatory requirements on quality, raw materials sourcing, and documentation, to support your finished product approval across major markets worldwide, minimizing regulatory risk for your pharmaceutical or medical device product.
Notably, our research and GMP grade products meet the same strict set of specifications, ensuring fast translation times from R&D to clinic.
Gelatin methacryloyl (GelMA)-based biomaterials have been widely used in various biomedical research applications due to their suitable biological properties and tunable physical characteristics. Especially over the past 5 years, GelMA-oriented research and patent applications have been growing exponentially, and many of these research concepts are now being translated towards the clinic. Suitable GelMA biomaterials are therefore indispensable to keep pace with the newest medical innovations.
- Drug / gene / growth factor delivery
- Tissue engineering
The clinical potential of GelMA based biomaterials is huge. Depicted here is GelMA at work to control heart bleeding from cardiac penetration wounds (see Hong et al. 2019). GelMA excels as a bioglue because of its very strong adhesion to wet and mobile tissues.
In GelMA hydrogels, the inherent bioactivity and compatibility of gelatin is combined with the tailorability of photo-crosslinking which has huge potential for culturing eukaryotic cells such as various types of stem cells at body temperature. Upon generation of a free radical (e.g., by light exposure in the presence of a photoinitiator), the methacrylamide side groups on the GelMA chains polymerize via non-toxic radical addition-type polymerization to yield a viscoelastic gelatin network interconnected through short polymethacryloyl chains. These hydrogels therefore are perfectly suited for a variety of 3D culture systems and bioapplications.
Standard GelMA products carry impurities originating from the precursor gelatin (pyrogens) and from the chemical synthesis process ((poly)methacrylic acid). For commercial research grade GelMA products, impurity levels can be high, not specified and inconsistent. This can affect both in vitro and clinical applications of GelMA biomaterials. Rousselot’s X-Pure GelMA products are purified via a controlled proprietary process to guarantee consistent, ultra-low levels of pyrogens (e.g. endotoxins and DNA), methacrylic acid, and insoluble debris: enabling a fast and efficient approval process.
Impurity analysis of commercially available GelMA grades showed a high and variable level of soluble impurities such as LPS, MA, and DNA and a high level of insoluble debris (pellets after centrifugation of 1-ml of 8% w:w solutions) in all products. Rousselot’s patented process securely removes precursor and process impurities, resulting in consistent ultra-low impurity levels.
X-Pure GelMA products for research or clinical application are manufactured by a revolutionary and proprietary production process. Compared to conventional / lab-scale GelMA production, Rousselot designed a process centered around a two-stage purification routine enabling fast and efficient GelMA production that is fully controlled from gelatin solubilization to GelMA drying. This results in ultra low impurity levels on the end product and batch-to batch product consistency.
By working with Rousselot as your development and manufacturing partner, you can gain access to Rousselot’s patent portfolio, and, optionally, gain exclusive access for your specific application to further protect your innovation.
X-Pure GelMA is produced via a proprietary multistage manufacturing process including chemical derivatization, two purification steps, filtering, and drying. This process is performed under controlled clean room conditions with qualification and validation under GMP.
By staying on top of current and upcoming regulations and guidelines we are able to support you with proper regulatory information regarding our GMP grade GelMA qualities, manufactured according to up-to-date standards. This regulatory support helps to minimize product development time and accelerate product approval.