EpiVax Expands Laboratory Facilities to Advance Immunogenicity Risk Assessment Services

EpiVax Expands Laboratory Facilities

EpiVax, Inc., a recognized market leader in immunogenicity risk assessment, recently announced a significant expansion of its laboratory facilities located at its headquarters in Providence, Rhode Island. This upgrade has enabled the company to more than double its laboratory space, enhancing the capabilities of its contract research organization (CRO) to conduct sophisticated immunological testing. This investment addresses the increasing demand for integrated, human-relevant 'New Approach Methodologies' (NAMs) for immunogenicity risk evaluation, acknowledging that conventional animal models often yield limited results applicable to human immunogenicity.

According to guidelines established by global regulatory authorities, NAMs have become integral to the preclinical evaluation of immunogenicity for biologics, peptides, novel therapies, generics/biosimilars, and critical quality attributes (CQAs). The view is shifting from considering immunogenicity solely as an observation in late-stage clinical trials to a mechanistically grounded, human-relevant risk continuum. This continuum is now being investigated early and throughout the entire development process using integrated in-silico and in-vitro systems to characterize specific components of immune activation before clinical exposure, establishing a foundation for optimized bioanalytical and clinical strategies.

With state-of-the-art in-silico tools for assessing immunogenicity risk, a comprehensive array of in-vitro assays to evaluate both innate and adaptive immune responses, and an expert team in place, EpiVax is well-positioned to act as a preferred 'one-stop-shop' partner for therapeutics developers. Their multidimensional, NAM-centered immunogenicity risk assessments (IRA) set a new standard in the field.

EpiVax’s laboratory conducts research involving human whole blood, PBMCs (peripheral blood mononuclear cells), and specialized antigen-presenting cells such as dendritic cells. Their platform assays are designed to be scalable and modular, adapting to the specific development phase, therapeutic modality, throughput, and immunological questions being explored. This modular approach allows for assessing immunogenicity risks based on measurements of cellular activation, phenotyping, proliferation, and cytokine secretion, providing insights into the impact of immunological risks on various aspects of immune responses.

The custom assays offered by EpiVax complement their in-silico analyses through the ISPRI toolkit, allowing for a thorough risk assessment based on orthogonal methodologies. This approach delivers the advantages of streamlined workflows, data consistency, and collaborative scientific investigation.

EpiVax boasts a proven track record in applying its multi-tiered in-silico and in-vitro methods for evaluating immunogenicity risk, including its PANDA screening framework for generic peptide products. This strategic approach combines computational analyses with targeted in-vitro methods to assess risks related to sequences and CQAs while ensuring comparability with reference products. Over the past years, EpiVax has successfully supported more than 16 global regulatory submissions using this framework, validating its effectiveness in producing data-driven, mechanistically-based IRAs aligned with evolving regulatory expectations.

"EpiVax is committed to delivering human-relevant, computational, and cell-based IRA solutions that empower therapeutics developers to make informed, data-driven decisions from discovery to market launch," stated Dr. Vibha Jawa, Chief Science Officer at EpiVax. "With our laboratory expansion, we will be able to support our partners more efficiently than ever before."

About EpiVax

EpiVax partners with biologics developers to manage immunogenicity risk across the entire product lifecycle. Leveraging substantial scientific expertise alongside industry-leading in-silico analyses and in-vitro approaches, insights gathered from actionable data help partners mitigate uncertainties, reduce risks, and allocate resources more effectively while developing regulatory-ready strategies for safer, more effective therapies. Visit www.epivax.com for more information.