First presented at Bio Digital 2020, Rousselot‘s X-Pure GelMA is the world’s first GMP-ready gelatin methacryloyl (GelMA or Gel-MOD) for preclinical and clinical applications in regenerative medicine. GelMA is a gold-standard biomaterial, ideal as a bioink for 3D bioprinting and tissue engineering, owing to its guaranteed ultra-low impurity levels and mechanical properties. The company, a global leader in collagen and gelatin materials, also recently launched the new X-Pure GelDAT bioink.
GMP (Good Manufacturing Practices) standards are required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of pharmaceutical products and medical devices (as well as food and beverages, cosmetics and dietary supplements). These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use.
Impurity analysis of commercially available GelMA (or Gel-MOD) bioink 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. Chemical derivatization, two purification steps, filtering, and drying were performed under controlled cleanroom conditions with qualification and validation under GMP.
X-Pure GelMA creates tunable biological environments for culturing various cells at body temperature. It is functionalized via photocrosslinking. This activates the methacrylamide side groups, causing them to polymerize, creating a viscoelastic gelatin network, making it one of the most versatile hydrogels available for 3D cell culture. It can also help reduce development time to clinic, for pharmaceutical, medical device and advanced therapy medicinal products, as well as cell and gene therapy products.
GelMA hydrogels can be synthesized with a specific degree of functionalization (DoM) and molecular weight (MW) or adjusted to the intended application.
Meet X-Pure GelDAT
Last May, Rousselot also introduced the X-Pure GelDAT (Gelatin Desaminotyrosine) bioink, which combines purity with superior adhesion performance to increase the potential of in-body applications reaching the clinic.
Created in response to customer’s demand to overcome the barriers encountered in clinic translation, this is the first, readily available biomaterial of its kind. The X-Pure GelDAT bioink offers guaranteed purity and consistency at scale, vital to the successful development of biomedical applications used in the human body.
Until now, one of the go-to products for researchers requiring a biomaterial more adhesive than GelMA – Gelatin Methacryloyl, was GelTYR – Gelatin Tyramine. However, GelTYR has several limitations, most notably its irreproducibility and the lack of a scalable production process. The chemical reactions required to make GelTYR lead to uncontrollable side reactions, which can significantly delay product development and negatively impact the likelihood of success.
Dr. Jeff Daelman, Business Development Manager at Rousselot Biomedical said, “Based on our extensive experience and scientific expertise in modified gelatins, we created a versatile, effective and scalable alternative to GelTYR. Rousselot Biomedical delivered a tailored X-Pure GelDAT solution, from customer’s initial briefing into pre-clinical trials in less than a year!”
Rousselot’s proprietary, scalable process means products with customized functionalities can be produced in a standardized, purified, traceable and consistent manner. Rousselot offers the best of both worlds: a customized yet consistent product on which both researchers and large pharmaceutical manufacturers can rely.
“Rousselot’s X-Pure GelDAT’s research-grade is functionally equivalent to the GMP grade material, so researchers have less risk of having to re-validate their biomaterial prior to clinical trials. Compromising on quality in early research can also cause significant scale-up issues and delays in preparation for clinical trials. X-Pure® GelDAT can be used throughout every development phase,” said Dr. Daelman.
New X-Pure GelDAT is a unique addition to the Rousselot portfolio because of its phenolic modification that grants superior adhesion properties to human tissues and because it can be cross-linked by both enzymatic reaction or photo-induction. These characteristics allow its combination with other biomaterials for the creation of more versatile and complex structures for drug delivery, tissue engineering, organ-on-a-chip and complex wound dressing applications
Dr. Daelman concluded: “This is an exciting time for the biomedical sector as highly purified and reliable gelatin-based materials unlock the potential for new innovations. We are excited to collaborate with customers and to jointly develop new gelatin-based solutions, that have a positive impact in these promising fields of research.”