Customized for Antibody Therapeutic Development

Customized Assay Design for Therapeutic Antibody Development

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Comprehensive Support Across All Stages of Development

Comprehensive Support Across All Stages of Development

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

DISCOVERY & SCREENING

Fc effector function profiling uncovers what neutralization misses, driving smarter candidate selection.


By screening antibodies beyond neutralization, Fc profiling revealed immune mechanisms like phagocytosis and NK cell activation that contribute to in vivo efficacy. This approach helped identify polyfunctional antibodies earlier in the pipeline, giving developers a functional lens to prioritize candidates with greater therapeutic potential.


  • Exposed functional differences not seen in neutralization assays
  • Delivered early insight into effector mechanisms linked to protection
  • Enabled faster, data-driven down-selection of clinically promising mAbs
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LEAD SELECTION

Go beyond neutralization, select leads based on what they actually do.


Even with identical Fc backbones, antibodies can show dramatically different effector profiles due to differences in epitope targeting and binding geometry. Broad Fc-function profiling across multiple assays (ADCC, ADNP, ADCD, and more) reveals subtle but actionable differences in activity. These insights help teams select lead candidates that best align with both the desired mechanism of action and pharmacokinetic goals.


  • Identifies functional differences not explained by Fc engineering alone
  • Supports lead selection based on mechanism-specific performance
  • Balances effector activity with enhanced half-life (e.g., via YTE modification)
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LEAD CHARACTERIZATION

Comparative Fc profiling reveals how design choices shape effector function.


Functional assays comparing Rituximab, Ofatumumab, and Obinutuzumab show distinct complement activity profiles, despite targeting the same antigen. These differences in C1q binding, ADCD, and CDC reflect how antibody structure, including Fc engineering, impacts mechanism of action. This comparative approach supports assay development and validation aligned with therapeutic goals.


  • Differentiates complement activity across similar CD20-targeting antibodies
  • Confirms Ofatumumab’s enhanced CDC via strong C1q and ADCD responses
  • Reveals how Fc modifications (e.g., afucosylation) alter functional outcomes
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CLINICAL EFFICACY TESTING

Fc profiling connects in vitro activity to real-world immune engagement


Comprehensive effector function profiling of nirsevimab (ADNP, ADCP, ADCD, ADCC) revealed innate immune activation not captured by neutralization assays alone. Ex vivo analysis of clinical serum samples confirmed that Fc-mediated activity persisted post-dose, tying lab results to patient-level immune response. This mechanistic clarity helped de-risk development and support clinical validation.


  • Demonstrated in vivo relevance of Fc-mediated activity in patient samples
  • Identified complementary immune pathways contributing to efficacy
  • Provided functional evidence to support clinical mechanism-of-action claims
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MANUFACTURING SCALE-UP

Functional profiling ensures consistency beyond structural analytics.


During transition from small-scale to large-scale antibody production, glycosylation changes were detected, but comprehensive Fc profiling confirmed functional consistency across manufacturing lots. By validating effector activity directly, our platform de-risks scale-up and preserves the intended therapeutic profile as production scales.


  • Confirmed effector function despite glycosylation shifts across lots
  • Added critical functional validation beyond standard structural assays
  • Supports end-to-end confidence from development through manufacturing
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SCIENTIFIC RESOURCES

May 12, 2025
Authors: Crescioli, S, Jatiani, S, & Moise, L, (2025). mAbs, 17(1). Journal: mAbs
October 1, 2024
Summary: This study offers significant insights into the profiling of approved anti-CD20 monoclonal antibodies (mAbs) using the SeromYx Fc effector function platform. By employing high-quality, full-length human CD20 virus-like particles (VLPs) from ACROBiosystems, we achieved a physiologically relevant assessment of antibody binding and effector functions. This enabled a detailed comparison between Type I (Rituximab and Ofatumumab) and Type II (Obinutuzumab) anti-CD20 mAbs, revealing distinct binding profiles and effector function capabilities. Our findings indicated that Type I mAbs demonstrated stronger binding to CD20-VLPs and to Fc receptors in the presence of antigen compared to the Type II mAb, highlighting how structural differences could influence their mechanisms of action. We observed an overall correlation between biophysical tripartite binding assays and effector cell function assays, validating the predictive utility of tripartite binding assays for mAb effector functions. Importantly, the discovery of robust antibody-dependent neutrophil phagocytosis (ADNP) and eosinophil phagocytosis (ADEP) activities for anti-CD20 mAbs significantly broadens our understanding of their potential in vivo mechanisms. These findings suggest that the involvement of neutrophils and eosinophils could impact the efficacy and safety of these mAbs in diverse disease states and tissue environments. Additionally, the differentiation between Type I and Type II mAbs across multiple assays underscores the importance of these distinctions in therapeutic applications and next generation antibody design. In conclusion, broadly profiling Fc effector function using the SeromYx Fc effector function platform not only recapitulated the known Fc effector functions of anti-CD20 mAbs but also uncovered novel potential mechanisms of action. These insights have substantial implications for optimizing current anti-CD20 therapies and developing new, more effective mAbs. Furthermore, the CD20-VLP system presents an opportunity to design and characterize mAbs with tailored effector function profiles for specific therapeutic applications, potentially leading to more personalized and effective treatments for a variety of diseases. Authors: P. Hsueh, M. Friedman, S. Jatiani (2024)