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.
With best-in-class in silico immunogenicity risk assessment tools, a comprehensive suite of in vitro assays fit to assess innate and adaptive immune responses, a team of renowned experts, and now an expanded laboratory capacity, EpiVax is well-positioned as a preferred "one stop shop" partner for a multidimensional, NAM-centric immunogenicity risk assessment (IRA) for therapeutic developers.
EpiVax's laboratory supports assessments in human whole blood, PBMC, and specialized professional antigen presenting cells, such as dendritic cells. The platform assays are scalable and modular – designed to fit the development phase, therapeutic modality, throughput, and immunological question at hand – leveraging cellular activation through phenotyping, proliferation, and cytokine secretion readouts to evaluate the impact of immune liabilities on different aspects of innate and adaptive immune responses.
The tailored assays provide complementary insights to EpiVax's in silico analyses (the ISPRI toolkit), enabling a comprehensive risk assessment consisting of orthogonal methods, with the benefit of streamlined workflows, data consistency, and inclusive scientific collaboration.
EpiVax has a strong demonstrated history in the application of its multi-phased in silico and in vitro immunogenicity risk assessment approach, including its PANDA screening framework for generic peptide products. This approach integrates computational analysis with targeted in vitro methods to assess sequence- and CQA-driven risk and establish comparability to reference products. EpiVax has supported more than 16 successful global regulatory submissions in recent years using this framework, demonstrating its effectiveness in enabling rigorous, mechanism-based IRAs aligned with evolving regulatory expectations.
"EpiVax aims to provide human-relevant computational and immune-cell based IRA solutions that allow therapeutic developers to make more informed, data-driven decisions from discovery through commercialization," said Vibha Jawa, Ph.D., CSO of EpiVax. "The expansion of our laboratory will allow us to support our partners in this goal more efficiently than ever before."
EpiVax partners with biologic developers to manage immunogenicity risk throughout the product lifecycle. Leveraging deep scientific expertise to apply industry-leading in silico analyses and in vitro approaches, insights from actionable data help our partners reduce uncertainty, mitigate risk, and use resources more efficiently while building regulatory-ready strategies for safer, more effective therapies.
Sarah Moniz, Director of Business Development & Marketing
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