EpiVax Expands Laboratory Facilities for Enhanced Immunogenicity Risk Assessment Services
EpiVax, Inc., a leading entity in the domain of immunogenicity risk assessment, has made significant strides in enhancing its laboratory capabilities. On June 23, 2026, the company unveiled an expansion of its laboratory facilities located in Providence, Rhode Island. This expansion is critical, as it more than doubles the laboratory's footprint, enabling EpiVax to support advanced immunological testing with unparalleled efficiency.
This investment in infrastructure reflects the heightened demand for Integrated, Human-relevant New Approach Methodologies (NAMs), particularly due to the growing limitations of traditional animal models when predicting human immunogenicity. Regulatory agencies worldwide are increasingly leaning towards NAMs for preclinical immunogenicity risk assessments related to biologics, generics, biosimilars, and critical quality attributes (CQAs). It is essential to understand that immunogenicity is not merely a late-stage clinical observation. Instead, it should be perceived as a continuum of human-relevant risk that can be evaluated proactively during the development of a therapeutic.
EpiVax has incorporated state-of-the-art in silico immunogenicity risk assessment tools and an expansive suite of in vitro assays tailored to measure both innate and adaptive immune responses. Additionally, they boast a team of highly regarded experts, solidifying their position as a preferred partner for a multidimensional, NAM-focused immunogenicity risk assessment (IRA) approach.
One of the laboratory’s primary functions involves assessments that utilize human whole blood, Peripheral Blood Mononuclear Cells (PBMCs), and specialized antigen-presenting cells like dendritic cells. The platform assays are designed to be scalable and modular, accommodating various therapeutic phases, modalities, throughput, and specific immune inquiries. This flexibility allows EpiVax to leverage cellular activation to assess the impact of potential immune liabilities on diverse aspects of immune responses.
EpiVax’s tailored assays complement its in silico analyses, facilitating comprehensive risk assessments that employ orthogonal methods to achieve efficient workflows, consistency in data, and collaborative scientific insights. As part of their commitment to innovation and scientific rigor, EpiVax has effectively utilized its multi-phased approach to immunogenicity risk assessment. This success is evidenced by their PANDA screening framework for generic peptide products, which melds computational analysis with targeted in vitro methods to assess and ensure comparability with reference products.
Over the past few years, EpiVax has enabled more than 16 successful global regulatory submissions using its framework, affirming its efficacy in delivering thoroughly reviewed, mechanism-based IRAs that align with the constantly evolving regulatory expectations.
Dr. Vibha Jawa, Chief Scientific Officer of EpiVax, emphasized the company's objective: "EpiVax aims to provide human-relevant computational and immune-cell based IRA solutions that allow therapeutic developers to make informed decisions from discovery through commercialization. The expansion of our laboratory will allow us to support our partners in this goal more efficiently than ever before."
EpiVax’s mission centers around aiding biologics developers in managing immunogenicity risks throughout the entire product lifecycle. By leveraging profound scientific expertise and industry-leading analyses, EpiVax aims to provide actionable insights that reduce uncertainty, mitigate risks, and optimize resources. This strategic approach ensures that their partners can confidently build regulatory-ready strategies that lead to safer and more effective therapies.
For more information about EpiVax and their advanced risk assessment solutions, visit their official website at www.epivax.com.
This investment in infrastructure reflects the heightened demand for Integrated, Human-relevant New Approach Methodologies (NAMs), particularly due to the growing limitations of traditional animal models when predicting human immunogenicity. Regulatory agencies worldwide are increasingly leaning towards NAMs for preclinical immunogenicity risk assessments related to biologics, generics, biosimilars, and critical quality attributes (CQAs). It is essential to understand that immunogenicity is not merely a late-stage clinical observation. Instead, it should be perceived as a continuum of human-relevant risk that can be evaluated proactively during the development of a therapeutic.
EpiVax has incorporated state-of-the-art in silico immunogenicity risk assessment tools and an expansive suite of in vitro assays tailored to measure both innate and adaptive immune responses. Additionally, they boast a team of highly regarded experts, solidifying their position as a preferred partner for a multidimensional, NAM-focused immunogenicity risk assessment (IRA) approach.
One of the laboratory’s primary functions involves assessments that utilize human whole blood, Peripheral Blood Mononuclear Cells (PBMCs), and specialized antigen-presenting cells like dendritic cells. The platform assays are designed to be scalable and modular, accommodating various therapeutic phases, modalities, throughput, and specific immune inquiries. This flexibility allows EpiVax to leverage cellular activation to assess the impact of potential immune liabilities on diverse aspects of immune responses.
EpiVax’s tailored assays complement its in silico analyses, facilitating comprehensive risk assessments that employ orthogonal methods to achieve efficient workflows, consistency in data, and collaborative scientific insights. As part of their commitment to innovation and scientific rigor, EpiVax has effectively utilized its multi-phased approach to immunogenicity risk assessment. This success is evidenced by their PANDA screening framework for generic peptide products, which melds computational analysis with targeted in vitro methods to assess and ensure comparability with reference products.
Over the past few years, EpiVax has enabled more than 16 successful global regulatory submissions using its framework, affirming its efficacy in delivering thoroughly reviewed, mechanism-based IRAs that align with the constantly evolving regulatory expectations.
Dr. Vibha Jawa, Chief Scientific Officer of EpiVax, emphasized the company's objective: "EpiVax aims to provide human-relevant computational and immune-cell based IRA solutions that allow therapeutic developers to make informed decisions from discovery through commercialization. The expansion of our laboratory will allow us to support our partners in this goal more efficiently than ever before."
EpiVax’s mission centers around aiding biologics developers in managing immunogenicity risks throughout the entire product lifecycle. By leveraging profound scientific expertise and industry-leading analyses, EpiVax aims to provide actionable insights that reduce uncertainty, mitigate risks, and optimize resources. This strategic approach ensures that their partners can confidently build regulatory-ready strategies that lead to safer and more effective therapies.
For more information about EpiVax and their advanced risk assessment solutions, visit their official website at www.epivax.com.
Topics Health）
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