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Tivic Health® Systems, Inc. (NASDAQ:TIVC), a diversified immunotherapeutics company, today announced that it has completed verification of its Entolimod™ cell line, the first step in establishing Current Good Manufacturing Practices (CGMP) in preparation for a Biologics License Application, or BLA.
Cell line verification in recombinant protein production is required because it ensures the processes used to grow cells and activate protein expression do not compromise the structural integrity of the protein or cause unwanted modifications that might adversely affect a protein's function.
As part of the verification process, Tivic successfully produced new Entolimod proteins with its partner, Scorpius Biomanufacturing. In vitro testing then verified that the resulting protein structure and yields are suitable to move into larger batch production.
Posted In: TIVC
