Centivax, a developer of broad-spectrum vaccines, announced on Tuesday that it has partnered with Emery Pharma, a California-based contract research organisation specialising in GLP/CGMP compliant solutions for analytical testing, bioanalytical testing and microbiology.
This partnership leverages Emery Pharma's expertise to develop an IND-enabling GLP compliant potency release assay for GMP batches of the Centivax pan-influenza universal vaccine clinical candidate, Centi-Flu.
Emery Pharma will establish a mass-spectrometry based comprehensive Centi-Flu expression and in-vitro potency assay, which will serve as the definitive batch release assay necessary for validating manufactured vaccine doses for use in the clinic and post-approval commercial doses. According to Centivax, Emery Pharma's expertise enables an unparalleled quantitative resolution to ensure that manufactured batches of Centi-Flu are released with uniform potency and quality for all components. The partnership further establishes a compatible process for potency batch release assays further enabling follow-on universal vaccines from the Centivax antibody and T-cell epitope focusing platform.
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