Customized for Vaccine Development

Customized for Vaccine Development

Lab scientists in white coats working in a modern, well-lit laboratory setting.

Comprehensive Support Across All Stages of Development

Comprehensive Support Across All

Stages of Development

From early discovery to clinical development, our Systems Serology platform provides customizable solutions to support each phase of vaccine development. Whether it’s mechanism of action analysis, functional profiling, or candidate optimization, we offer the insights needed to advance your projects.

DISCOVERY

Systems Serology identifies antibody features linked to disease outcomes.


Profiling hospitalized COVID-19 patients revealed distinct antibody responses: survivors showed a spike (S)-focused, functional profile, while non-survivors had nucleocapsid (N)-biased, less effective antibodies. Just five key antibody features predicted clinical trajectory, supporting early risk stratification and biomarker development. These findings highlight the importance of spike-specific functional antibodies for vaccine targeting.


  • Differentiates survivors and non-survivors using key antibody signatures
  • Links enhanced S-specific phagocytosis and complement activity to protection
  • Informs vaccine antigen selection and immune monitoring strategies
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LEAD SELECTION

Prioritize candidates by protective antibody functions, not just quantity.


Systems Serology enables comparison of vaccine regimens based on their ability to elicit key protective antibody functions. Screening HIV vaccine candidates revealed wide variation in ADCP levels despite similar antibody titers. Changes in adjuvants and dosing shifted functional profiles, helping developers select candidates that induce higher-quality immune responses. This accelerates confident, data-driven down-selection for clinical advancement.


  • Differentiates vaccine leads by antibody function, not just titer
  • Reveals impact of formulation and regimen on immune quality
  • Supports efficient selection of candidates with greater clinical potential
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ASSAY DEVELOPMENT, VALIDATION, QUALIFICATION

Robust immune profiling beyond neutralization for clinical trials.


SeromYx developed and qualified a Systems Serology assay under WHO and GCLP standards to measure antibody-dependent functions in SARS-CoV-2 vaccine trials. The assay delivers precise, specific, and sensitive measurement of Fc effector activities (ADCP, ADCD, ADNKA), supporting secondary endpoints in Phase 3 studies and regulatory filings. This validated platform is adaptable for diverse vaccine programs requiring advanced immune monitoring.


  • Ensures reproducible, regulatory-grade immune data across cohorts
  • Measures extra-neutralizing Fc functions linked to protection
  • Scalable qualification framework for broad vaccine applications
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CLINICAL EFFICACY TESTING

Uncovering antibody mechanisms linked to protection beyond neutralization.


A head-to-head study of mRNA-1273 and BNT162b2 vaccines showed both induced strong humoral responses, but mRNA-1273 elicited higher IgA titers, enhanced Fcγ receptor binding, and greater functional activity (ADNP, ADNKA). Systems Serology mapped distinct Fc effector functions, offering mechanistic insights into their differing real-world efficacy and supporting identification of correlates of protection.


  • Differentiates vaccine-induced functional antibody profiles linked to protection
  • Detects spike-specific Fc activities beyond neutralization
  • Provides mechanistic insight for clinical trial correlates and disease attenuation
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MANUFACTURING SCALE-UP

Integrating antibody avidity with Fc effector profiling to enhance vaccine assessment.


By combining Systems Serology with surface plasmon resonance (SPR)–based avidity measurements, this study uncovered distinct immune profiles differentiating two vaccine manufacturing processes. While one process drove higher effector function with lower avidity, the other generated stronger avidity with reduced effector activity. Multivariate modeling highlighted avidity, NK cell IFNγ responses, and IgG1 as key features distinguishing the processes, providing mechanistic insight into how manufacturing influences vaccine-induced immunity.


  • Links antibody avidity with functional immune readouts
  • Differentiates immune profiles across vaccine manufacturing processes
  • Provides mechanistic insight to guide vaccine design and optimization
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SCIENTIFIC RESOURCES

Design and engineering of bispecific antibodies: insights and practical considerations

October 28, 2025
The Fc Review: How does Fc engineering shape bispecific antibody function? A Frontiers in Bioengineering and Biotechnology review explores how the Fc region can be tuned to control effector function, half-life, and safety, key levers in the design of next-generation bispecific antibodies ( bsAbs ). Background: Bispecific antibodies bring new therapeutic possibilities by engaging multiple targets at once. But this complexity also brings new challenges, from unwanted immune activation to altered pharmacokinetics . The Fc region plays a central role here, acting as both a stabilizing scaffold and a regulator of immune effector engagement

An Fc-Engineered Glycomodified Antibody Supports Proinflammatory Activation of Immune Effector Cells and Restricts Progression of Breast Cancer

October 23, 2025
Abstract: Fc engineering to enhance antibody effector functions harbors the potential to improve therapeutic effects. Understanding FcγR expression and distribution in the tumor microenvironment prior to and following treatment may help guide immune-engaging antibody design and patient stratification. In this study, we investigated FcR-expressing immune effector cells in HER2 + and triple-negative breast cancers (TNBC), including neoadjuvant chemotherapy–resistant disease. FcγRIIIa expression, FcγRIIIa + NK cells, and classically activated (M1-like) macrophages correlated with improved anti-HER2 antibody efficacy. FcγRIIIa protein and FcγRIIIa + NK cells and macrophages were present in primary TNBC and retained in treatment-resistant tumors.

Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial

September 15, 2025
Background Authorized COVID-19 vaccines require boosters for continued protection; however, the lack of crossplatform compatible boosters creates practical challenges to keeping populations protected. Methods This Phase 3, multicenter, international, randomized, active-controlled trial compared UB-612 as a thirddose heterologous booster to BNT162b2, ChAdOx1-S, or BBIBP-CorV homologous boosters in healthy subjects aged ≥16 years. Participants were randomly assigned 1:1 to receive a single intramuscular injection of UB-612 or an active comparator matching the primary dose, and were stratified for age, sex, N-protein seropositivity, and time since the last dose of their primary series COVID-19 vaccination. The primary objective was to show noninferiority of neutralizing antibody geometric mean titer (GMT) against live SARS-CoV-2 Wuhan strain after boosting with UB-612 or each of the licensed platform vaccines. Secondary and exploratory objectives covered short and long-term antibody responses. The safety analysis addressed subject and investigator reported adverse events. The study was registered on ClinicalTrials.gov, NCT05293665, and completed on September 12, 2023.