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GELITA launches Endotoxin Controlled Excipients for bioscience applications

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

GELITA, a leading manufacturer of collagen and gelatin, proudly announces the launch of itsย Endotoxinย Controlledย Excipientsย (ECE) portfolio.[1]ย This cutting-edge product line, featuring VACCIPROยฎ and MEDELLAPROยฎ, meets the stringent demands of modern biomedical and pharmaceuticalย applications, including vaccine stabilization, medical devices, and 3D bioprinting.

In pharmaceutical, medical device and healthcare environments,ย endotoxinย control is crucial to ensure product safety and patient well-being.ย GELITAโ€™s ECE portfolio offers pure, highly specialized medical grade gelatins and collagen peptides that are used in a wide range of biomedicalย applications. VACCIPROยฎ and MEDELLAPROยฎ provide optimal stability, are biocompatible by nature, and facilitate the development of safe and efficient products.

VACCIPROยฎ

As a collagen peptide with a long history of use for vaccine stabilization, VACCIPROยฎ 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, VACCIPROยฎ is ideal for liquid and lyophilized formulations, serving as an excellent scaffold to stabilize vaccine antigens and other protein-containing components.ย GELITAย carefully produces VACCIPROยฎ to comply with US and European pharmacopeial requirements.

MEDELLAPROยฎ

Lowย endotoxinย MEDELLAPROยฎ gelatin used by manufacturers for parenteralย applicationsย and medical devices, including blood-clotting sponges, implants and cell cultures, as well as 3D bioprintingย applicationsย 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, MEDELLAPROยฎ 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 worldโ€™s leading pharmacopoeias and offers high purity, low allergenic potential, low bioburden and high affinity for tissue cells.

Both VACCIPROยฎ and MEDELLAPROยฎ comply with international standards, including ISO 22442 for traceability, and are supported by Virus Inhibition Studies (VIS) and Drug Master Files (DMF).ย Endotoxinย levels, expressed inย Endotoxinย Units (EU/g), areย controlled, with gelatin grades ranging fromย โ‰ค100 [EU/g] toย โ‰ค3000 [EU/g], ensuring the highest levels of purity and consistency.

โ€œThe 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 theย GELITAย Pharma Institute and our Biotech R&D Hub in Frankfurt, we are well-equipped to expand our biotechnological expertise and product portfolio,โ€ says Martin Junginger, Category Manager, Global Marketing & Innovation Management.

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

GELITA
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