EpiVax Expands Laboratory Facilities and Enhances In Vitro Services Focused on NAM-C

EpiVax Expands Laboratory Facilities for Enhanced Immunogenicity Services

EpiVax, Inc., a leader in immunogenicity risk assessment, has recently announced a substantial expansion of its laboratory facilities at its headquarters in Providence, Rhode Island. This expansion more than doubles the size of the company’s laboratory space, which significantly boosts EpiVax's capabilities to conduct advanced immunological studies.

The modernization of EpiVax's facilities aligns with the growing demand for human-relevant methodologies known as "New Approaches" (NAM). These are designed to evaluate immunogenicity risk, keeping in mind the limitations of traditional animal models in providing applicable immunogenicity results for humans. As global regulatory agencies have begun to emphasize NAM, they have become central to preclinical assessments of immunogenicity risk for biological products, emerging modalities, generics, and biosimilars, alongside essential quality attributes (CQA).

EpiVax advocates for viewing immunogenicity not just as a clinical observation at advanced phases but as a continuum of risks founded on mechanisms relevant to human responses. This concept allows risk evaluation to occur from the earliest development stages through integrated in silico and in vitro systems. These assessments characterize specific components of immune activation before clinical exposure and lay the groundwork for optimized bioanalytical and clinical strategies.

With state-of-the-art in silico tools for assessing immunogenicity risk, a comprehensive suite of in vitro tests evaluating both innate and adaptive immune responses, and a renowned team of experts, EpiVax is poised to be a preferred partner in the field. The company holds a strong position as a one-stop solution, offering a multidimensional approach to immunogenicity risk assessment (IRA) centered on NAM for developers of therapeutic treatments.

EpiVax's laboratory is capable of conducting analyses on human whole blood, PBMC, and specialized antigen-presenting cells such as dendritic cells. The platform’s tests are scalable and modular, tailored to fit the development phase, therapeutic modality, throughput, and the immunological questions being studied. These tests focus on cell activation, phenotyping, proliferation, and cytokine secretion to evaluate the impacts of immunological risks on various aspects of innate and adaptive immune responses.

These custom tests provide additional insights to EpiVax’s in silico analyses, leveraging its ISPRI toolkit. This comprehensive risk assessment approach benefits from streamlined workflows, data consistency, and inclusive scientific collaboration. EpiVax possesses a proven track record in implementing its multi-phase immunogenicity risk assessment framework, particularly through its PANDA screening platform for generic peptide products. This method fuses computational analysis with targeted in vitro techniques to assess risks tied to sequence and key quality criteria, establishing comparability with benchmark products. In recent years, EpiVax has significantly contributed to the success of over 16 regulatory submissions globally, showcasing the framework's effectiveness in delivering rigorous IRA that adhere to evolving regulatory expectations.

"EpiVax aims to provide IRA solutions based on computational modeling and immune cells that are human-relevant, enabling treatment developers to make more informed and data-driven decisions—from discovery through to commercialization," said Vibha Jawa, Ph.D., Chief Scientific Officer at EpiVax. "The expansion of our laboratory will empower us to support our partners in achieving this objective with unprecedented efficiency."

About EpiVax

EpiVax collaborates with developers of biological products to manage immunogenicity risks throughout the product life cycle. Leveraging deep scientific expertise, EpiVax implements advanced in silico and in vitro analyses, wherein actionable data helps partners reduce uncertainties, mitigate risks, and allocate resources more effectively while preparing regulatory strategies for safer and more effective treatments. For more information, visit www.epivax.com.