GELITA Launches Ultra Low Endotoxin Gelatin for Biomedical Use

GELITA has launched an ultra low endotoxin gelatin, specified at less than 10 endotoxin units (EU) per gram, for sensitive biomedical applications including hydrogels, drug delivery systems, and injectable formulations where pyrogen control is critical.

The grade, branded MEDELLAPRO Ultra Low Endotoxin, was announced alongside the company’s wider excipient range at BIO International 2026 in San Diego. It extends GELITA’s Endotoxin Controlled Excipients (ECE) portfolio, a line of gelatin and collagen peptide excipients positioned for drug delivery, vaccine stabilization, tissue engineering, 3D bioprinting, and regenerative medicine.

“Renowned for its expertise in gelatin and collagen peptides, GELITA continues to set new standards for safety, performance, and sustainability in the pharmaceutical and medical device sectors.”

Gelatin and endotoxin control

Gelatin is a protein produced by the partial hydrolysis of collagen, and it is widely used in pharmaceutical formulation as a gelling agent, a film former, and a structural material for capsules, hemostatic agents, and tissue scaffolds. Endotoxins are bacterial lipopolysaccharides that act as pyrogens, and their control is a core safety requirement for parenteral and implantable products, where even trace contamination may trigger a febrile or inflammatory response. Setting a tight endotoxin limit on the raw material is one way formulators can reduce that risk before manufacturing begins.

GELITA said the new grade is specified below 10 EU per gram, a level it describes as suited to the most demanding applications, including the production of reproducible, biocompatible hydrogels. The company presents the figure as a purity benchmark rather than a clinical claim, and the suitability of any grade still depends on the dosage form, the route of administration, and the validated process.

Endotoxin contamination is a recurring concern in injectable and implantable development, because it can affect both patient safety and batch release. Bacterial endotoxin limits are a standard part of compendial release testing for parenteral products, so a lower starting level in the excipient may give formulators additional headroom against the finished-product limit. Tighter control at the raw-material stage may also shorten the path to a compliant formulation, although performance in a finished product is ultimately determined by the full formulation and process.

Within the ECE range, GELITA highlighted two flagship products. MEDELLAPRO, a gelatin, is positioned for surgical sealants, hemostatic agents, scaffolds, and drug delivery systems, which the company attributes to its biocompatibility and formulation flexibility. VACCIPRO, a collagen peptide, is positioned for stabilizing vaccines and injectables, and GELITA says it offers low allergenic potential and high tolerability while protecting sensitive molecules.

“This next-generation grade is specifically engineered for the most sensitive biomedical applications, enabling the production of highly reproducible and biocompatible hydrogels.”

The company also said it is developing animal-free, recombinant collagen proteins through biotechnological processes, which it presents as a more resource-efficient and sustainable route to biomedical collagen. Recombinant production can reduce animal-sourced variability and the associated viral-safety screening burden, though GELITA did not publish performance or availability data for these materials.

GELITA said in its statement that its endotoxin-controlled excipients may have implications for drug delivery, vaccine stabilization, tissue engineering, 3D bioprinting, and regenerative medicine.

GELITA will showcase its latest advancements in excipient technology
at BIO International 2026 in San Diego (Booth 3335-DF).
The firm will detail its recombinant work in a conference lecture, “The Role of Non-Animal Recombinant Collagen Proteins in Biomedical Applications: From Vaccine Stabilization to Artificial Organs,” presented by GELITA senior R&D manager Michelle Montgomery on June 23, 2026 at 2:45 PM
Visit also GELITA at Booth 3335-DF in the German Pavilion

See the original GELITA press release here:

GELITA PR_BioInternational_JUN26_final

Sources

GELITA AG, GELITA Unveils Next-Generation Excipient Innovations at BIO International 2026 in San Diego, June 2026. www.gelita.com.
BIO International Convention 2026, Biotechnology Innovation Organization. www.bio.org.

This article is intended for biopharmaceutical formulation, process, and regulatory professionals. It does not constitute clinical, regulatory, or formulation advice. Always refer to the current pharmacopoeial monograph, the supplier’s current technical data sheet and Certificate of Analysis, applicable ICH/FDA/EMA guidance, and your own development and stability data. Pharma Excipients International AG is not a manufacturer of the excipients discussed.

Read our introduction article on Gelatin as a Pharmaceutical Excipient: