EpiVax Announces Laboratory Expansion and Streamlined, NAM-Centric In Vitro Services
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.”
More about EpiVax’s In Vitro Services
At the core of EpiVax’s in vitro offerings are three complementary stimulation platforms: Whole blood, peripheral blood mononuclear cells (PBMC), and specialized APCs like mature macrophages and dendritic cells (DC) that mimic professional tissue derived APCs. Each platform provides a distinct biological context for evaluating immune activation. Whole blood captures integrated innate responses across all circulating immune cells and supports clinically relevant cytokine release assessments. PBMC-based approaches enable evaluation of innate and adaptive immune responses, including early priming and late-stage T cell activation and population-level variability across HLA types. Additionally, the macrophage and dendritic cell-based specialized systems provide insight into antigen processing, presentation, and early signaling events that drive downstream T cell responses.
-
Whole Blood Assay: Evaluates cytokine release from human whole blood following exposure to a test article using multiplexed cytokine analysis (Luminex). Provides early insight into immune overstimulation risk and innate activation mechanisms, bridging in vitro biology with clinical feasibility in a relevant whole blood system. Commonly used to assess potential immunotoxicities due to immunomodulatory therapies (i.e., cytokine storm due to T cell engagers or CAR-T constructs) and innate activation due to critical quality attributes (i.e., impurities, contaminants, aggregates, novel chemistries).
- Modalities: This assay is compatible with conventional and next generation proteins (i.e., mAbs, bsAbs, ADCs, cytokine-based therapies, CAR-T constructs), peptides, nucleic acids, and novel delivery vectors for cell and gene therapies.
- Use Cases: Candidate selection, first-in-human risk mitigation, impurity risk characterization, comparability/manufacturing change assessments, excipient/formulation screening.
-
PBMC Assay: A modular assay used to evaluate innate and/or adaptive immune responses through cytokine profiling (Luminex or FluoroSpot) and cell activation/proliferation (flow cytometry) readouts. The assay can be customized in scale and design to support discovery, characterization, or specific questions for regulatory submissions. For example, appropriate donor numbers, days of incubation, benchmarks, and readouts can be selected according to stage of development and therapeutic modality of interest. Commonly used as orthogonal support to in silico analyses to assess immunogenic potential of candidates and informing population risk, as well as to assess innate to adaptive priming (i.e., translation of CQA innate stimulation to an enhanced adaptive response).
- Modalities: This assay is compatible with non-immunomodulatory proteins (i.e., mAbs, bsAbs, CAR-T domains, enzymes, hormones, HCPs), peptides, nucleic acids, mRNA/LNP, and viral capsids.
- Use Cases: Candidate selection/optimization, first-in-human risk mitigation, impurity risk characterization, and comparability/manufacturing change assessments.
-
DC:PBMC Assay: Uses dendritic cell and PBMC co-culture to assess adaptive immune responses in a more mechanistic context through cell activation/proliferation (flow cytometry) and cytokine profiling (Luminex). Particularly valuable for immunogenicity risk assessment of immunomodulatory products. May be simplified to a DC Activation Assay where necessary. Loaded DCs can also be used for an orthogonal immunopeptidomics (MAPPs) readout.
- Modalities: This assay is compatible with immunomodulatory proteins (i.e., mAbs, bsAbs) and peptides (particularly unnatural and cyclic peptides).
- Use Cases: Candidate selection, first-in-human risk mitigation, comparability/manufacturing change assessments, excipient/formulation/route of administration/dose screening.
-
Class II HLA Binding Assay: A cell-free assay that measures the relative binding affinity of peptides or peptide regions derived from protein sequences to a panel of recombinant Class II HLA alleles, using a fluorescence-based readout. Often used to validate in silico HLA binding predictions and as a first-line approach for peptides containing high levels of unnatural amino acids that may not be suitable for computational analysis.
- Modalities: Peptides, synthetic peptides, generic peptide APIs, and peptides containing high levels of unnatural amino acids.
- Use Cases: Validation of in silico predictions, peptide impurity assessment, generic peptide development, and orthogonal confirmation of HLA binding potential.
-
PANDA® Screening: A solution designed for sponsors pursuing the Abbreviated New Drug Application (ANDA) Pathway for generic peptide drugs in which FDA guidance requires sponsors to identify and characterize process and product-related impurities in their drug formulations with innate and adaptive immunogenicity risk assessments. EpiVax adapted its proprietary in silico and in vitro methods for assessing immunogenic risk to offer Peptide Abbreviated New Drug Application (PANDA®) Screening – a set of orthogonal analyses tailored to specifically meet ANDA sponsors’ immunogenicity assessment needs for generic peptides and their related impurities.
- Class II HLA Binding Assay: Measures the relative binding affinity of API and impurity peptides (or putative T cell epitope regions of the sequences) to Class II HLA alleles.
- T Cell Assay: Tests the ability of API and impurity peptides to stimulate a T cell response using human PBMC.
- Innate Immune Response Assay: Used to assess innate immunogenicity of generic and RLD products using human PBMC.
These platforms support a modular assay suite that can be tailored and deployed strategically to answer specific questions across the development lifecycle. They are applied to evaluate specific risks based on development stage, modality, and program needs. This enables teams to perform the right assay at the right time, from early-stage initial risk characterization or candidate comparison/optimization through later-stage risk assessment and comparability studies (to support formulation changes, process scale-up, manufacturing modifications, or clinical observations). Modular assay selection enables targeted investigation of these variables, helping maintain a current, stage-appropriate risk profile.
This flexible approach drives measurable return on investment by reducing unnecessary preclinical stage (animal) and clinical stage testing, focusing resources on the most relevant risks, and enabling more confident, data-driven decisions before clinical stage impacts arise. When integrated with computational predictions in vitro data helps sponsors de-risk development earlier, avoid late-stage surprises, and build stronger, regulatory-ready packages.
These capabilities align closely with the growing regulatory emphasis on new approach methodologies (NAMs). Agencies increasingly recognize advanced in silico and in vitro systems using human cells as more predictive of clinical outcomes than traditional animal models, particularly for immune-mediated risk such as cytokine release and immunogenicity. By leveraging human-relevant assays, sponsors can generate mechanistic data that better reflects patient biology while supporting efforts to reduce reliance on animal testing.
With this expansion, EpiVax strengthens its ability to deliver integrated, patient-relevant insights that reduce uncertainty and help bring safer, more effective therapies to patients.
Interested in learning how these in vitro capabilities can support your program? Contact our team to start the conversation.
