In the ever-evolving landscape of bioscience and medical technology, innovation is not just a buzzword — it’s a necessity. The healthcare industry is constantly on the lookout for groundbreaking solutions to overcome common obstacles and support a range of complex medical applications. This is key to enhancing patient care, improving treatment outcomes and pushing the boundaries of what’s possible.

Battling endotoxins: a critical challenge

One of the biggest challenges in applications such as medical devices and 3D bioprinting technology including sensible cell cultures is maintaining low endotoxin levels. If left unchecked, endotoxins can trigger severe immune responses and cause tissue inflammation or even septic shock. This is why regulatory bodies enforce strict endotoxin thresholds for end products [1]. Ensuring these levels are kept to a minimum is essential. This is when MEDELLAPRO® comes into play. Our pure, highly specialized pharmaceutical-grade gelatin is designed to help maintain low endotoxin levels and ensure both product and patient safety.

Low endotoxin gelatin Derived from collagen, MEDELLAPRO® closely mimics the natural extracellular matrix of the human body, providing a biocompatible and biodegradable solution that is safely absorbed by the body with time. What sets this gelatin apart is its versatility, allowing it to be tailored for various mechanical properties such as stiffness, elasticity and strength. The specialized gelatin can be processed into a wide range of forms, including hydrogels, films and nanoparticles, making it suitable for diverse applications. Its outstanding purity, low allergenic potential and high biocompatibility by nature ensure its safety in medical and pharmaceutical purposes.

MEDELLAPRO® in medical devices

Used as an endotoxin-controlled excipient, MEDELLAPRO® significantly reduces the risk of triggering spontaneous immune responses such as inflammatory side effects. For instance, the low endotoxin gelatin can be used for hemostatic agents in surgical procedures and trauma care to help stop bleeding. It absorbs large amounts of blood, sticks to the wound and promotes blood clotting. Another use is in wound care, wherein MEDELLAPRO® hydrogels provide a matrix that supports cell growth and tissue regeneration while keeping the wound safe from external contaminants and supporting the healing process through the different stages.

3D bioprinting with MEDELLAPRO®

In 3D bioprinting technology, gelatin scaffolds made from MEDELLAPRO® can be tailored to precisely mimic specific tissue characteristics, promoting the regeneration of various tissues such as bone, cartilage and skin. Its rheological properties make it ideal for 3D bioprinting and allow the creation of tissues layer by layer. Additionally, by adjusting the unique features of MEDELLAPRO® in artificial tissue scaffolds, researchers can test novel pharmaceuticals and potentially reduce the need for animal studies. But the potential applications don’t stop here.

More application possibilities: drug delivery, embolization and diagnostic imaging

MEDELLAPRO® gelatin can be used as a carrier for controlled and targeted release in drug delivery systems or as an embolic agent (blocking blood flow to tumors, for example). Furthermore, it also shows promise as a contrast agent for diagnostic processes such as magnetic response and ultrasound imaging. With its unparalleled flexibility and natural compatibility to human tissue, MEDELLAPRO® continues to pave the way for innovative solutions to complex medical challenges and meet the needs of modern healthcare.

Interested in learning more about how MEDELLAPRO® can help to improve your parenteral, medical device and 3D bioprinting applications? Contact our experts at GELITA today.

Reference

[1] U.S. Food and Drug Administration (2012): Guidance for Industry. Pyrogen and Endotoxins Testing: Questions and Answers. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-pyrogen-and-endotoxins-testing-questions-and-answers#_ftn7