PROVIDENCE, R.I., June 23, 2026 /PRNewswire/ -- EpiVax, Inc., a recognized leader in immunogenicity risk assessment, announces the expansion of its laboratory facilities at its Providence, RI headquarters. The upgraded space has more than doubled the company's laboratory footprint, expanding the CRO's capacity to support advanced immunological testing. This investment reflects growing demand for integrated, human-relevant, new approach methodologies (NAMs) to evaluate immunogenicity risk due to limitations of traditional animal models to provide human-relevant immunogenicity readouts.
Per global regulatory agency guidance, NAMs have become a central component of preclinical immunogenicity risk assessment for biologics, peptides, emerging modalities, generics/biosimilars, and critical quality attributes (CQAs). It is suggested that immunogenicity should not be viewed solely as a late-stage clinical observation, but rather as a mechanistically informed, human-relevant risk continuum that can be interrogated early and throughout development using integrated in silico and in vitro systems to characterize specific components of immune activation before clinical exposure and to inform optimized bioanalytical and clinical strategies.
