Assess humoral and cellular immune responses in preclinical models with customized study designs and validated assays.
Successful mRNA vaccine development requires a rigorous assessment of the immune responses they elicit in vivo. Our preclinical immunogenicity service provides a comprehensive evaluation of both humoral and cellular arms of the adaptive immune system following mRNA-LNP immunization in rodent models.
Using customized immunization schedules and a suite of validated in vitro assays, we measure binding antibody titers, neutralizing antibody activity, antigen-specific T-cell responses, and cytokine profiles. Biodistribution of the mRNA and expression of the encoded antigen are also assessed to correlate delivery with immune outcomes. This integrated approach delivers the data needed to optimize candidate selection, dose, formulation, and regimen before advancing to larger animal or clinical studies.
The service is designed for vaccine developers, CROs, and academic labs seeking high-quality, publication-ready immunogenicity data to support regulatory filings and guide lead candidate decisions.
Key Features
Humoral Immunity Profiling
Quantitation of total IgG, IgA, and IgM titers against the vaccine antigen using validated ELISA or multiplex platforms. This includes endpoint titers, avidity measurements, and isotype distribution to characterize the antibody response magnitude and quality.
Neutralizing Antibody Assays
Assessment of functional neutralizing capacity using pseudovirus or live virus neutralization assays. We provide half-maximal inhibitory concentration (IC50) and, when relevant, breadth of neutralization across variant panels to evaluate the vaccine's ability to block infection.
T-Cell Response Analysis
Detection of antigen-specific T cells by ELISpot (IFN-γ, IL-2, IL-4, IL-13, TNF-α) and intracellular cytokine staining (ICS) with flow cytometry. Both CD4+ and CD8+ responses are quantified, including polyfunctional subsets and memory markers (central memory, effector memory, terminal effector).
Biodistribution and Expression
Determination of mRNA distribution and persistence in target tissues (e.g., spleen, lymph nodes, injection site) by qRT-PCR, and quantification of antigen expression by ELISA or Western blot on tissue homogenates. This links delivery to immune activation and informs dose–response relationships.
Readout Options
We tailor the readout panel to your vaccine candidate, formulation, and study goals. The following assays are available and can be combined in a single study.
Binding Antibody ELISA (total Ig / IgG subclasses / IgA): Quantitative endpoint and avidity measurements against recombinant antigen or full-length spike protein.
Pseudovirus Neutralization Assay (pVNT): Uses lentiviral or VSV pseudotypes bearing variant surface glycoproteins; readout via luciferase or fluorescent reporter in permissive cell lines.
Live Virus Neutralization Assay (prNT50): Plaque reduction neutralization test or micro-neutralization with authentic virus in BSL-2/3 facilities as required.
T-Cell ELISpot (single- or dual-color): Antigen-specific spot-forming units per million splenocytes or PBMCs for key cytokines (IFN-γ, IL-2, TNF-α, IL-4, IL-13).
Intracellular Cytokine Staining (ICS) and Flow Cytometry: Multiparametric analysis of T-cell activation, proliferation (Ki67), memory subsets, and polyfunctionality using custom panels.
Workflow
Our immunogenicity evaluation follows a structured workflow from study design through final data report. We coordinate closely with your team to ensure endpoints and sampling align with your vaccine development timeline.
Study Design & Protocol Review: We define animal species/strain, group size, immunization regimen (dose, route, schedule), bleeding time points, and assay endpoints. A detailed study protocol is prepared for your approval before work begins.
Animal Immunization & Sample Collection: RNA-LNP formulations are administered according to the approved schedule, with interim bleeds and terminal collection as specified.
Humoral Assays: Binding antibody titers are measured by ELISA. Neutralizing activity is assessed using pseudovirus or live virus neutralization assays. Assays are performed with appropriate positive/negative controls and in replicate to ensure reproducibility.
Cellular Assays: Splenocytes or PBMCs are stimulated with antigen pools; ELISpot and/or ICS are performed. Flow cytometry data are acquired on a standardized cytometer and analyzed with a validated gating strategy.
Data Analysis & Final Report: All raw data, analysis methods, and statistical comparisons are compiled in a comprehensive report. We provide individual animal data, group summaries, and graphical presentations suitable for regulatory submission or publication.
Customizable at Every Step
Study parameters—including number of doses, bleed intervals, antigen concentration, and assay panel—are defined in consultation. We adapt to your specific vaccine platform and desired endpoints, whether for early discovery screening or late-stage regulatory-supportive studies.
Quality Assurance
All studies are conducted in accredited facilities (where applicable) with adherence to the 3Rs principles of replacement, reduction, and refinement. Sample handling, processing, and storage follow GLP-like standard operating procedures. Assays are validated for precision, linearity, and specificity; each analytical run includes appropriate positive, negative, and background controls.
Data integrity is ensured through electronic audit trails, blinded sample analysis where requested, and independent quality assurance review. Final reports are reviewed by a second scientist before release to maintain the highest standards of accuracy and reliability.
Why Choose Us
Integrated Humoral + Cellular Readout: Obtain a complete immunogenicity picture from a single study—binding antibodies, neutralization, and T-cell responses—reducing timelines and inter-study variability.
Customized Study Design: Every study is designed from the ground up to match your vaccine candidate, dosing regimen, and target endpoints. Flexible bleed schedules and optional biodistribution assessments are available.
Validated Assay Platforms: Assays are run with established protocols, internal controls, and quality gates. Neutralization assays use both pseudovirus and live virus options; cellular assays include dual-color ELISpot and multiparameter flow cytometry.
Regulatory-Supportive Data Packages: Data are presented in a format suitable for INDs and other regulatory filings. Reports include detailed methods, raw data, and statistical analysis to facilitate review.
Backed by Creative Biogene: All projects are delivered under Creative Biogene's ISO-aligned quality system, with dedicated project management, milestone-based reporting, and full intellectual property protection for your data.
Sample Types & Tissues
We process a variety of biological samples collected during the study. The list below describes typical sample types and the assays applied.
Serum / Plasma: Used for binding antibody ELISA, neutralization assays, and cytokine quantification. Collected at multiple time points to monitor immune kinetics.
PBMCs / Splenocytes: Isolated from blood or spleen for T-cell ELISpot and ICS. Cryopreservation available for batch analysis.
Lymph Nodes: Harvested for germinal center analysis or antigen-specific B-cell characterization (optional).
Injection Site Tissues: Collected for mRNA biodistribution (qRT-PCR) and local antigen expression (ELISA, Western blot).
Contact Us
Whether you are selecting a lead vaccine candidate, optimizing dose and regimen, or preparing a regulatory data package, the scientific team at Creative Biogene can help you design the most appropriate immunogenicity evaluation strategy—from assay panel selection through data interpretation. Reach out to discuss a tailored solution for your next project.
