Tivic Health Systems Inc. (Nasdaq: TIVC), a diversified therapeutics company based in Fremont, California, has announced a definitive agreement with Scorpius BioManufacturing. This agreement aims to complete the GMP manufacturing validation of Tivic's lead candidate, Entolimod™, which is intended for the treatment of Acute Radiation Syndrome $(ARS.UK)$. The validation process is a crucial step in preparing for the submission of a Biological Licensing Application $(BLA.AU)$ to the U.S. Food & Drug Administration. Scorpius BioManufacturing, a subsidiary of Scorpius Holdings Inc. (OTC:SCPX) and an experienced contract development and manufacturing organization, will leverage its facility in San Antonio, Texas, for the process. The GMP Validation Program, valued at approximately $4.1 million, includes comprehensive activities to ensure a complete chemistry, manufacturing, and control $(CMC)$ package is submitted to the FDA. The partnership highlights Scorpius' expertise in biomanufacturing and its strategic advantage in manufacturing the product domestically, aiming for streamlined commercial success.
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