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EpiVax Expands Laboratory Facilities for Enhanced Testing

EpiVax, Inc., a leading company recognized for its role in immunogenicity risk assessment, has recently announced a significant expansion of its laboratory facilities located in Providence, Rhode Island. The enhancement has effectively more than doubled the laboratory space, thereby augmenting the organization's capacity to support advanced immunological testing. This strategic investment reflects the increasing demand for integrated methodologies relevant to human studies and the innovative New Approach Methodologies (NAM) aimed at evaluating immunogenicity risk. Traditional animal models have often struggled to provide results that are applicable to human immunogenicity, making the transition to NAM critical.

According to global regulatory agencies' guidelines, NAM has become a fundamental component in preclinical immunogenicity risk assessment for biologics, peptides, emerging modalities, generics/biosimilars, and critical quality attributes (CQA). It is recommended that immunogenicity should not be viewed solely as a late clinical observation; instead, it should be treated as a relevant human risk continuum, grounded in mechanistic analysis. Such analysis can be conducted from the initial stages of product development and throughout its lifecycle using integrated in silico and in vitro systems. This approach characterizes specific components of immune activation prior to clinical exposure and supports optimized bioanalytical and clinical strategies.

With first-class in silico immunogenicity risk assessment tools, a comprehensive suite of in vitro assays designed to evaluate both innate and adaptive immune responses, a renowned team of experts, and now expanded laboratory capabilities, EpiVax has positioned itself as a preferred partner. The company offers a holistic solution for a multidimensional NAM-centered immunogenicity risk assessment (IRA) that is essential for therapy developers in the biopharmaceutical landscape. EpiVax's lab empowers comprehensive assessments using whole human blood, peripheral blood mononuclear cells (PBMC), and specialized antigen-presenting cells such as dendritic cells. The assays available through the platform are modular and scalable, tailored to accommodate developmental phases, therapeutic modalities, and specific immunological inquiries by leveraging cellular activation through phenotyping, proliferation, and cytokine secretion assays.

Customized assays also provide complementary information to EpiVax’s in silico analyses (via the ISPRI toolkit), enabling a comprehensive risk evaluation built on orthogonal methodologies. This combination allows EpiVax to execute optimized workflows, consistent data outcomes, and inclusive scientific collaboration.

EpiVax boasts a robust track record of applying its multifaceted in silico and in vitro immunogenicity risk assessment approach, including the PANDA screening framework for generic peptide products. This methodology seamlessly integrates computational analysis with specific in vitro techniques to assess risk derived from sequence and CQA while establishing comparability with reference products. Over the recent years, EpiVax has successfully supported more than 16 global regulatory submissions utilizing this framework, showcasing its effectiveness in facilitating rigorous, mechanistically based immunogenicity risk assessments that align with evolving regulatory expectations.

"EpiVax aims to deliver research and analysis solutions related to immune response (IRA) that are cell-based and relevant to human contexts, empowering therapy developers to make more informed, data-driven decisions from discovery through commercialization," stated Vibha Jawa, Ph.D., EpiVax’s Chief Scientific Officer. "The expansion of our laboratory facilities will enable us to support our partners in achieving these objectives more efficiently than ever."

About EpiVax

EpiVax collaborates with developers of biological products to manage immunogenicity risk throughout the product lifecycle. The company harnesses deep scientific expertise to apply industry-leading in silico and in vitro analyses, generating actionable insights that assist partners in reducing uncertainty, mitigating risks, and utilizing resources more effectively. The ultimate aim is to create regulatory-ready strategies that lead to the development of safer and more effective therapies. For more information, please visit www.epivax.com.

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