GELITA launches Endotoxin Controlled Excipients for bioscience applications

New portfolio comprises innovative collagen solutions for parenteral applications, medical devices and 3D bioprinting

GELITA, a leading manufacturer of collagen and gelatin, proudly announces the launch of its Endotoxin Controlled Excipients (ECE) portfolio.^[1] This cutting-edge product line, featuring VACCIPRO® and MEDELLAPRO®, meets the stringent demands of modern biomedical and pharmaceutical applications, including vaccine stabilization, medical devices, and 3D bioprinting.

In pharmaceutical, medical device and healthcare environments, endotoxin control is crucial to ensure product safety and patient well-being. GELITA’s ECE portfolio offers pure, highly specialized medical grade gelatins and collagen peptides that are used in a wide range of biomedical applications. VACCIPRO® and MEDELLAPRO® provide optimal stability, are biocompatible by nature, and facilitate the development of safe and efficient products.

VACCIPRO®

As a collagen peptide with a long history of use for vaccine stabilization, VACCIPRO® ensures the safety and effectiveness of both human and animal vaccines. It has low allergenic potential, high tolerance by the body and an affinity for tissue cells. Recognized by global vaccine producers as the gold standard, VACCIPRO® is ideal for liquid and lyophilized formulations, serving as an excellent scaffold to stabilize vaccine antigens and other protein-containing components. GELITA carefully produces VACCIPRO® to comply with US and European pharmacopeial requirements.

MEDELLAPRO®

Low endotoxin MEDELLAPRO® gelatin used by manufacturers for parenteral applications and medical devices, including blood-clotting sponges, implants and cell cultures, as well as 3D bioprinting applications such as bioinks and scaffolds. Being superior biocompatibility, printability, and biodegradability by nature, makes it ideal for fabricating complex tissue structures with remarkable precision and efficacy. By replacing human tissue grafts, MEDELLAPRO® offers a cost-effective and less invasive alternative that improves patient comfort and reduces risk. It meets the requirements of the gelatin monographs of the world’s leading pharmacopoeias and offers high purity, low allergenic potential, low bioburden and high affinity for tissue cells.

Both VACCIPRO® and MEDELLAPRO® comply with international standards, including ISO 22442 for traceability, and are supported by Virus Inhibition Studies (VIS) and Drug Master Files (DMF). Endotoxin levels, expressed in Endotoxin Units (EU/g), are controlled, with gelatin grades ranging from ≤100 [EU/g] to ≤3000 [EU/g], ensuring the highest levels of purity and consistency.

“The ECE portfolio underlines our commitment to advancing biomedical solutions through innovation and decades of expertise. In the future, we want to use biotechnological processes to produce animal-free alternatives with optimized properties that are even more resource-efficient and sustainable than conventional methods. With the pharmaceutical know-how of the GELITA Pharma Institute and our Biotech R&D Hub in Frankfurt, we are well-equipped to expand our biotechnological expertise and product portfolio,” says Martin Junginger, Category Manager, Global Marketing & Innovation Management.

To find out more, please visit www.gelita.com.