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Viral Vaccine Assay Services for Influenza, HIV, and Emerging Pathogens

ASSAY PRECISION FOR EVERY STAGE OF VACCINE DEVELOPMENT

Developing viral vaccines demands more than routine testing. It requires assay systems that reflect real-world viral biology, regulatory expectations, and clinical trial realities. At Microbiologics, we design and execute influenza and HIV vaccine assays that generate defensible, submission-ready data across preclinical and clinical development. From hemagglutination inhibition and microneutralization to neuraminidase inhibition and custom neutralization platforms, we help you measure immune response, potency, and protection with confidence.

Viral Vaccine Testing and Immunogenicity Assay Services


From reference strains to validated assays to clinical trial sample analysis


We support vaccine developers through every phase of development with:

  • Hemagglutination inhibition (HAI) assays
  • Microneutralization (MN) assays
  • Neuraminidase inhibition (NAI/ELLA) assays
  • HIV neutralization and binding assays
  • Custom assay design and validation
  • BSL-2 and BSL-3 viral containment
  • Preclinical and GCLP-compliant clinical testing
  • Assay qualification, optimization, and transfer

Our scientists collaborate directly with your team to ensure the assay strategy aligns with your vaccine construct, platform, and regulatory pathway. To ensure technical consistency and data integrity, our influenza vaccine assays are performed in alignment with World Health Organization (WHO)–recommended methodologies where applicable. We incorporate positive control sera on each plate and perform viral back-titration to confirm infectious input within predefined acceptance criteria. Plate-level system suitability checks and defined quality control parameters are applied prior to data release, reinforcing assay robustness and reproducibility across preclinical and clinical studies.

Turnaround Time and Throughput for Viral Vaccine Assay Studies


Vaccine development timelines are rarely static, and assay support needs to keep pace. Our operational model is designed to deliver both speed and scalability without compromising data quality. Typical turnaround time ranges from 3 to 4 weeks, depending on assay type and batch size. For time-sensitive programs, we work closely with sponsors to accommodate accelerated timelines, with 2 to 3 week turnaround achievable based on study design and capacity planning.

Our high-throughput workflows support 1,000+ samples per study, enabling efficient processing of large clinical cohorts while maintaining consistency across plates, runs, and study phases. Whether you are advancing a small preclinical study or managing complex, multi-cohort clinical trials, we align assay execution with your program timelines to help keep development on track.

Data Deliverables for Vaccine Assay Analysis and Regulatory Submission


Generating high-quality assay data is only part of the equation. We ensure your results are delivered in formats that support clear interpretation, internal decision-making, and regulatory submission.

Standard deliverables include raw assay data, calculated titers, and summary outputs such as geometric mean titers (GMTs) and seroconversion analyses where applicable. Comprehensive study reports document assay conditions, controls, acceptance criteria, and results to support transparency and reproducibility. Based on your program needs, we also provide customized data packages, including assay plate images, sequencing reports, and tailored statistical analyses.

Quality Systems Supporting Viral Vaccine Testing and Submission-Ready Data


Our viral vaccine assay services are supported by a comprehensive quality framework designed to ensure consistency, traceability, and regulatory alignment at every stage of your study.

We operate under an established Quality Management System (QMS) aligned with applicable GLP and GMP expectations, with all work governed by standardized SOPs, controlled documentation, and defined workflows to support reproducibility and audit readiness.

Data integrity and traceability are maintained across samples, reagents, and results, ensuring full transparency from receipt through final reporting. All personnel are trained and qualified on relevant methods prior to study execution, and assays are validated or qualified as appropriate to ensure accuracy, precision, and reliability.

Dedicated QA oversight includes review of study plans, raw data, and final reports, supported by internal audits and continuous improvement processes. Structured systems for deviation management, CAPA, and change control ensure that any issues are documented, investigated, and resolved in a controlled and compliant manner.

Throughout each study, we maintain clear communication and documentation to provide full visibility into study execution and data quality.


Influenza Vaccine Hemagglutination Inhibition (HAI) Assay Services

Measure functional antibody responses with WHO-aligned influenza strains

The hemagglutination inhibition assay remains a cornerstone of influenza vaccine immunogenicity evaluation. Our HAI assays quantify functional antibodies that block viral hemagglutinin from binding red blood cells, providing established correlates of protection for seasonal and pandemic influenza programs.

We offer:

  • Influenza A and B strains
  • WHO-recommended seasonal strains
  • Pandemic and avian influenza strains
  • Testing in single, duplicate, or triplicate formats
  • Monoclonal and purified antibody analysis
  • Human and preclinical species serum analysis (e.g., mouse, ferret)
  • Positive control sera in parallel
  • Geometric mean titers and seroconversion analysis

Representative Influenza HAI Reference Strains

Our hemagglutination inhibition (HAI) assay services are supported by a broad panel of seasonal, historical, and pandemic influenza A and B reference strains. The list below represents commonly requested isolates for influenza vaccine immunogenicity testing. Additional WHO-recommended and emerging strains are available upon request.

These strains are suitable for evaluation of geometric mean titers, seroconversion rates, and functional antibody response in preclinical and clinical vaccine studies.

Influenza A (H1N1)

IsolateCommon Application
A/Puerto Rico/08/1934Historical reference strain
A/California/7/20092009 pandemic H1N1
A/Michigan/45/2015Seasonal vaccine evaluation
A/Wisconsin/588/2019Seasonal strain
A/Victoria/4897/2022Recent WHO-recommended strain


Influenza A (H3N2)

IsolateCommon Application
A/Perth/16/2009Seasonal vaccine development
A/Texas/50/2012Seasonal immunogenicity testing
A/Switzerland/9715293/2013Cross-reactivity studies
A/Hong Kong/4801/2014Vaccine strain evaluation
A/Darwin/6/2021Recent seasonal strain
A/Darwin/9/2021Contemporary H3N2 isolate


Influenza B – Yamagata Lineage

IsolateCommon Application
B/Massachusetts/2/2012Quadrivalent vaccine evaluation
B/Phuket/3073/2013WHO-recommended strain


Influenza B – Victoria Lineage

IsolateCommon Application
B/Malaysia/2506/2004Seasonal reference strain
B/Brisbane/60/2008Quadrivalent vaccine programs
B/Wisconsin/1/2010Immunogenicity benchmarking
B/Austria/1359417/2021Recent seasonal isolate


Influenza B – Victoria Lineage

IsolateCommon Application
B/Malaysia/2506/2004Seasonal reference strain
B/Brisbane/60/2008Quadrivalent vaccine programs
B/Wisconsin/1/2010Immunogenicity benchmarking
B/Austria/1359417/2021Recent seasonal isolate


Avian Influenza – H5N1

IsolateCommon Application
Reassortant LPAI H5N1 (Clade 2.3.4.4b)Vaccine immunogenicity and neutralization assay development
H5 HA polybasic site removed (HPAI converted to LPAI)Functional antibody testing under BSL-2 conditions
BSL-3 HPAI H5N1 (wild-type virus)Assay development and validation under high-containment conditions


Avian Influenza – H7N9

IsolateCommon Application
BSL-2–compatible H7N9 systems (e.g., reassortant or pseudovirus)Pandemic preparedness, vaccine evaluation, and neutralization / immunogenicity studies
BSL-3 H7N9 (wild-type virus)Assay development and validation under high-containment conditions


Need a Different Strain?

We routinely update our influenza panels to reflect current WHO recommendations and emerging variants. If your vaccine candidate requires a specific seasonal, pandemic, or avian strain, our team can source, manufacture, and qualify the appropriate virus to support your HAI immunogenicity studies.

Influenza Vaccine Hemagglutination Inhibition (HAI) Assay Services

Influenza Vaccine Microneutralization (MN) Assay Services

Quantify neutralizing antibody potency with cell-based viral inhibition assays

Our microneutralization assays evaluate the ability of vaccine-induced antibodies to inhibit viral infection in susceptible cell lines. This cell-based neutralization assay provides sensitive detection of functional antibody responses beyond HAI alone.

We deliver:

  • MN50 and MN90 titers
  • Neutralization curves
  • Cytopathic effect monitoring
  • Approximately 100 TCID50 challenge dose
  • Reference sera benchmarking
  • Seasonal and avian influenza panels

Representative Influenza Microneutralization (MN) Reference Strains

Our influenza microneutralization (MN) assay services are supported by a focused panel of seasonal influenza A and B strains commonly used in vaccine neutralizing antibody studies. The strains listed below represent frequently requested isolates for evaluating functional antibody-mediated viral inhibition in preclinical and clinical vaccine programs.

These strains support determination of MN50 and MN90 titers, neutralization curves, and cytopathic effect inhibition using standardized infectious doses.

Influenza A (H1N1)

IsolateCommon Application
A/Wisconsin/588/2019Seasonal vaccine neutralization assessment


Influenza A (H3N2)

IsolateCommon Application
A/Darwin/9/2021Contemporary H3N2 neutralizing antibody evaluation


Influenza B – Yamagata Lineage

IsolateCommon Application
B/Phuket/3073/2013Quadrivalent vaccine neutralization testing


Influenza B – Victoria Lineage

IsolateCommon Application
B/Austria/1359417/2021Recent seasonal neutralization studies
B/Malaysia/2506/2004Historical benchmarking and cross-reactivity analysis


Expanding Beyond the Representative Panel

Neutralization responses can vary significantly by strain and lineage. If your influenza vaccine candidate requires additional WHO-recommended seasonal strains, pandemic H1N1 or H3N2 isolates, or emerging variants, our team can source, manufacture, and qualify the appropriate virus for MN assay support.

These assay platforms can also be adapted to support antiviral compound evaluation and viral inhibition studies, providing flexibility for programs that span both vaccine and therapeutic development.

Influenza Vaccine Microneutralization (MN) Assay Services

Influenza Vaccine Neuraminidase Inhibition (NAI) ELLA Assay Services

Measure anti-neuraminidase immunity using Enzyme-Linked Lectin Assay (ELLA)

Neuraminidase inhibition assays provide critical insight into vaccine-induced protection beyond hemagglutinin. Using the ELLA platform, we quantify inhibition of neuraminidase enzymatic activity via fetuin substrate cleavage and optical density readouts. NAI assays can be performed using both wild-type and reassortant influenza viruses. For neuraminidase-focused evaluations, reassortant or antigenically mismatched viruses are often preferred to isolate NA-specific antibody responses and minimize hemagglutinin interference.

Our NAI ELLA capabilities include:

  • NA activity quantification
  • IC50 and IC90 determination
  • Enzyme inhibition profiling
  • Optical density measurement and curve analysis
  • Seasonal and avian influenza strains
  • Fluorometric or ELLA formats

Representative Neuraminidase Inhibition (NAI/ELLA) Reference Strains

Our neuraminidase inhibition (NAI) Enzyme-Linked Lectin Assay (ELLA) services are supported by a panel of seasonal and historical influenza A and B reference strains. The strains listed below represent commonly requested isolates for evaluating anti-neuraminidase antibody responses in influenza vaccine development programs.

These strains support measurement of neuraminidase inhibition titers, IC50 and IC90 calculations, and functional enzyme activity profiling in both preclinical and clinical vaccine studies.

Influenza A (H1N1)

IsolateCommon Application
A/California/7/20092009 pandemic H1N1 neuraminidase profiling
A/Michigan/45/2015Seasonal vaccine immunogenicity
A/Wisconsin/588/2019Contemporary seasonal evaluation


Influenza A (H3N2)

IsolateCommon Application
A/Perth/16/2009Seasonal NA antibody response
A/Texas/50/2012Cross-strain inhibition studies
A/Hong Kong/4801/2014Vaccine strain evaluation
A/Darwin/6/2021Recent seasonal strain
A/Darwin/9/2021Contemporary H3N2 isolate


Influenza B – Yamagata Lineage

IsolateCommon Application
B/Massachusetts/2/2012Quadrivalent vaccine evaluation
B/Phuket/3073/2013Quadrivalent vaccine evaluation


Influenza B – Victoria Lineage

IsolateCommon Application
B/Malaysia/2506/2004Seasonal reference strain
B/Wisconsin/1/2010Immunogenicity benchmarking
B/Brisbane/60/2008Quadrivalent vaccine support
B/Austria/1359417/2021Recent seasonal isolate


Looking for a Specific Neuraminidase Target?

Influenza vaccine strategies increasingly evaluate neuraminidase immunity alongside hemagglutinin responses. If your program requires a specific WHO-recommended strain, emerging variant, or custom neuraminidase panel, our team can source, manufacture, and qualify the appropriate virus to support your NAI ELLA studies.

Influenza Vaccine Neuraminidase Inhibition (NAI) ELLA Assay Services

HIV Vaccine Neutralization and Immunogenicity Assay Services

Functional immunity testing for complex HIV vaccine programs

HIV vaccine development demands precise, reproducible, and biologically relevant assays capable of evaluating both neutralizing and non-neutralizing immune responses. Our team supports preclinical and clinical HIV vaccine studies with validated platforms designed to measure viral infectivity, antibody potency, viral load, and Fc-mediated effector function.

We work with primary cells, established T-cell lines, and reporter systems to generate defensible data aligned with global HIV vaccine research standards.

Representative HIV Strain Panel

Our HIV-1 and HIV-2 panels include well-characterized laboratory and clinical isolates commonly used in neutralization and infectivity studies.

HIV-1

  • SPM-10516 (BEI ARP-1413)
  • 92/BR/003 (BEI ARP-1751)
  • 92/US/660 (BEI ARP-1722)
  • RU132 (BEI ARP-3509)
  • RTMDR1 (BEI ARP-2529)
  • NL43 (Recovered by reverse genetics)

HIV-2

  • SPM-10518 (BEI ARP-1108)
  • CBL-20 (BEI ARP-600)
  • CDC310072 (ARP-3649)

Additional clade-specific and custom isolates available upon request.

HIV Vaccine Assay Platforms

Service AreaKey CapabilitiesClinical Stage SupportThroughput Scalability
HIV Growth and PropagationPBMCs, CD4+ and CD8+ T-cell lines, macrophages; chronic infection and latency modelsPreclinicalCustom
Infectivity and Titration (TCID50)p24 ELISA (HIV-1), p27 ELISA (HIV-2), TZM-bl reporter assays, CPE-based titration, qPCR titrationPreclinical and ClinicalScalable
Viral Load QuantificationqRT-PCR, ddPCR, intracellular antigen flow cytometry developmentPreclinical and ClinicalHigh
Microneutralization AssaysAntibody and small-molecule screening; MN50 dose-response analysisPreclinical and ClinicalScalable
Fc-Mediated Functional AssaysADCC (NK-mediated killing), ADCP (phagocytosis), CDC (complement-mediated lysis)Preclinical and ClinicalCustom


What This Means for Your HIV Vaccine Program

Biologically relevant systems
We work with primary cells and permissive T-cell lines to reflect true viral infectivity and immune interactions.

Functional antibody assessment
From neutralization to Fc-effector function, we support evaluation of both protective and non-neutralizing immune mechanisms.

Quantitative viral load analysis
Sensitive qRT-PCR and digital droplet PCR (ddPCR) platforms enable precise viral quantification across development stages.

Scalable study design
Assay throughput is structured to expand as vaccine programs move from exploratory studies to larger clinical cohorts.


Need a Specific Clade or Custom Neutralization Panel?

If your HIV vaccine strategy targets a specific clade, recombinant construct, or Fc-effector pathway, our team can design a fit-for-purpose assay panel aligned with your development objectives. Complete the form below to connect directly with our HIV assay specialists.

HIV Vaccine Neutralization and Immunogenicity Assay Services

Custom Viral Vaccine Assay Development and Validation Services

Built for vaccine programs that do not fit inside a standard assay box

Not every vaccine candidate aligns neatly with a predefined assay panel. Novel constructs, emerging variants, recombinant platforms, and shifting regulatory expectations demand tailored solutions.

Our scientists partner directly with vaccine developers to design, optimize, validate, and transfer custom viral vaccine assays aligned to your antigen design, mechanism of action, and development stage. Whether you are advancing a preclinical candidate or generating GCLP-compliant clinical immunogenicity data, we build assays that reflect real viral biology and real regulatory requirements.

We support assay strategy across:

  • Neutralizing antibody evaluation
  • Functional infectivity testing
  • Viral quantification
  • Potency and stability assessment
  • Technology transfer and assay qualification

When needed, we integrate custom viral stock production, recombinant virus generation, and containment expertise to create a seamless workflow from strain to final data package.

Custom Viral Vaccine Assay Platforms

Assay PlatformOff-the-Shelf Strains AvailablePreclinical StudiesClinical Studies (GCLP)Throughput Scalability
Wild-Type Virus Neutralization AssaysAvailableYesYesHigh
Hemagglutination Inhibition (HAI)AvailableYesYesHigh
Neuraminidase Inhibition (NAI/ELLA)AvailableYesYesHigh
TCID50 Infectivity AssaysAvailableYesYesScalable
Digital Droplet PCR (ddPCR) Viral QuantificationAvailableYesCustomHigh
Quantitative PCR (qPCR)Custom DevelopmentYesCustomScalable
Recombinant and Reassortant Influenza SystemsCustomYesCase DependentCustom


Supported Viruses Include

We support assay strategy across:

  • SARS-CoV-2
  • Seasonal and avian influenza strains
  • RSV
  • Dengue virus
  • Herpes simplex virus (HSV)
  • Epstein-Barr virus (EBV)
  • Emerging and novel viral targets

If your vaccine program involves a specific WHO-recommended influenza strain, a recombinant construct, or a newly emerging variant, we can source, manufacture, and qualify the appropriate viral material to support your assay program.

What Sets Our Custom Assay Approach Apart

Integrated viral expertise
We combine assay development with in-house viral propagation, characterization, and containment capabilities, including BSL-2 and BSL-3 environments.

Fit-for-purpose design
Every assay is built around your construct, dosing strategy, and clinical endpoints. We do not retrofit your science into a generic template.

Regulatory-aligned workflows
From early feasibility studies to GCLP-compliant clinical sample testing, we design assays with submission-readiness in mind.

Collaborative execution
Our scientists work alongside your team to refine protocols, interpret data, and adjust strategy as your program evolves.


Let’s Design the Right Assay Strategy for Your Vaccine Candidate

If your viral vaccine program requires custom neutralization testing, infectivity assays, recombinant virus systems, or advanced viral quantification methods, we are ready to build a solution around your needs.

Complete the form below to connect directly with our virology team and discuss your assay development goals.

Custom Viral Vaccine Assay Development and Validation Services

Your Viral Vaccine Data Should Move You Forward, Not Slow You Down


From influenza HAI and microneutralization assays to HIV neutralization platforms and custom assay development, we provide scientifically defensible data aligned with regulatory expectations and real-world viral biology.

What sets our approach apart is integration. Viral propagation, strain characterization, assay development, and clinical sample testing are supported within the same organization, under BSL-2 and BSL-3 containment as required. Our in-house viral manufacturing capabilities allow us to control infectious input, maintain material consistency, and align assay design directly with your vaccine construct.

The result is tighter quality control, reduced variability, and a streamlined path from viral material to final data package.

If you are advancing a viral vaccine candidate and need assay support you can rely on, complete the form below to connect directly with our virology scientists.


Need more detail for planning or internal review?


Download our CRO Laboratory Services Catalog for a complete, shareable overview of our biomaterial manufacturing capabilities, assay offerings, deliverables, and workflows.

CRO Laboratory Catalog

LETS TALK ABOUT YOUR PROGRAM.

Connect with our virology team today to discuss your goals and explore how our viral vaccine testing services can support your next project.