EuBiologics announced Friday that its vaccine adjuvant platform, EcML™, has been registered with the U.S. Food and Drug Administration (FDA) Drug Master File (DMF) system and assigned an official registration number.
The newly registered Type IV DMF includes key chemistry, manufacturing and controls (CMC) information for EcML, including details on its raw materials, manufacturing process and quality specifications. A DMF allows pharmaceutical ingredient manufacturers to submit manufacturing and quality information directly to the FDA, providing a regulatory foundation that global developers can reference when filing Investigational New Drug (IND) applications and Biologics License Applications (BLA) for vaccines incorporating EcML.
EcML is a monophosphoryl lipid A (MPLA)-based adjuvant that enhances vaccine immunogenicity by activating toll-like receptor 4 (TLR4) in the body. The platform was developed using recombinant patented technology licensed from the Korea Institute of Science and Technology (KIST).
The company said its proprietary manufacturing process enables EcML to be produced directly from the cell membrane of genetically engineered Escherichia coli, simplifying production while delivering high scalability, purity, yield and cost competitiveness.
EuBiologics is currently developing a shingles vaccine, an RSV vaccine and an Alzheimer’s disease therapeutic vaccine incorporating EcML through its U.S. joint venture, EUPOP Life Sciences.
With the DMF registration complete, the company plans to expand not only its internal development pipeline but also collaborations and licensing agreements with global pharmaceutical companies.
In addition to the EcML active ingredient, EuBiologics has developed ELS, a liposome-based adjuvant formulation that can be supplied in either liquid or lyophilized form. The company expects to broaden commercial sales of vaccine ingredients and licensing opportunities by offering customized adjuvant materials and formulations tailored to partners’ development needs for vaccines and immunotherapies.
“The FDA DMF registration marks an important milestone that validates both the global credibility and commercial potential of the EcML platform,” a EuBiologics spokesperson said. “Global pharmaceutical companies can now reference the EcML DMF during U.S. development programs, creating new opportunities for co-development, technology licensing and expanded commercial supply of EcML and ELS products as we grow into a global adjuvant platform company.”
EuBiologics is a South Korean vaccine developer and manufacturer best known for its oral cholera vaccine. The company has recently expanded its vaccine portfolio with typhoid and meningococcal vaccines, accelerating its transition into a diversified vaccine manufacturer while building on the stable supply of its oral cholera vaccine.
