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Bioanalytical Capabilities for Biologics Development

Fit-for-purpose analytical solutions for every molecule, every milestone.

At Aurigene, we are a trusted CDMO/CRO partner offering end-to-end analytical development and manufacturing services tailored to the needs of your molecule along its journey from discovery to commercialization. Our expertise spans physicochemical and biological characterization, bioanalytical method development, and regulatory-compliant testing for a wide range of biotherapeutic modalities.

With a strong foundation in protein chemistry, we specialize in fingerprinting protein structures, quantifying impurities, and elucidating mechanisms of action through robust cell-based and ligand-binding assays. Whether you are developing a monoclonal antibody, a bispecific, or a complex fusion protein, we provide the analytical clarity you need to move forward with confidence.
 

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Our Core Capabilities:

Physicochemical Characterization

We offer comprehensive structural and compositional analysis of biologics, including:

  • Primary structure: Intact and fragmented mass analysis
  • Higher-order structure: Secondary/tertiary structure, disulfide linkages, melting point, and free thiol quantification
  • Post-translational modifications: Glycosylation profiling, oxidation, deamidation, and cleavage
  • Impurity profiling: Size and charge variants, glycation, and aggregation
  • Technologies: Mass spectrometry, HPLC/UPLC, circular dichroism, fluorometry, DSC, DLS, SEC-MALS, CEIEF, CESDS, Solo VpE

Biological Characterization

Our biological assays provide deep insights into functional activity and immunogenicity:

  • Cell-based assays: ADCC, CDC, proliferation, viability, receptor occupancy and many custom assays
  • Binding & potency: ELISA (direct, indirect, competition), SPR (BIAcore), and reporter gene assays
  • Immunogenicity studies:

    Innate immunogenicity:

    • TLR activation assays (HEK-Blue, RAW Blue)
    • PBMC-based cytokine release profiling

    Adaptive immunogenicity:

    • ADA (Tiered approach: screening, confirmatory, titration)
    • Neutralizing Antibody (NAb) assays

    Impurity-induced immunogenicity:

    • HEK TLR panels
    • T-cell activation and proliferation assays
  • Signaling pathways: GPCR activation, calcium flux, kinase phosphorylation
  • Clinical sample handling: Immunogenicity (ADA/NAb), PK/PD, and biomarker analysis
  • Technologies: Luminescence, fluorescence, multicolor flow cytometry, microscopy, and primary cell culture

Product-Specific Bioanalytical Services

We tailor our bioanalytical strategies to the unique demands of each biotherapeutic class:

Monoclonal Antibodies (mAbs)

  • ELISA-based assays: Binding affinity, potency, and activity using target-expressing cells
  • SPR kinetics: FcRn binding, receptor interaction, and epitope mapping
  • Cell-based assays: ADCC, CDC, receptor occupancy, and cytokine release
  • PRI assays: HCP (ELISA/LC-MS), HCD (qPCR), PAL (Protein A leachate)
  • PK/immunogenicity: Serum drug levels, ADA/NAb detection, and PD biomarker correlation

Bispecific Antibodies

  • Dual-target ELISA: Simultaneous arm-specific binding and functional bridging
  • SPR profiling: Independent kinetic analysis for each target
  • Cell-based assays: T-cell redirection, tumor killing, cytokine profiling, custom assays
  • PRI assays: HCP, HCD, PAL for both parental and final constructs
  • PK/ADA: Multiplexed detection and differentiated immunogenicity profiling

Biosimilars

  • Comparative ELISA: Potency, binding, and activity vs. reference product
  • SPR similarity testing: Affinity and kinetic equivalence
  • Cell-based assays: ADCC/CDC equivalence, signaling, viability and custom assays
  • PRI assays: Lot-to-lot HCP/HCD/PAL profiling
  • Immunogenicity & PK: Bridging assays and comparative ADA/NAb studies

Peptides

  • ELISA & SPR: Peptide-receptor binding and competitive inhibition
  • Cell-based assays: GPCR activation, enzyme inhibition, calcium flux, and many custom assays
  • PRI assays: HCP/HCD/PAL for peptide expression systems
  • PK & metabolite profiling: LC-MS/MS quantification and degradation mapping
  • IIRMIs: In Vitro Assessment of Immunostimulatory/Immune Response modulating Impurities

Complex Biologics (Fusion Proteins, ADCs, etc.)

  • Multi-attribute ELISA: Domain-specific binding and activity
  • SPR & LC-MS: DAR analysis, payload release, and domain kinetics
  • Cell-based assays: Cytotoxicity (MTT, CellTiter-Glo), receptor activation, internalization and many custom assays
  • PRI assays: HCP/HCD/PAL and payload quantification
  • PK/PD: LC-MS/MS for linker stability and exposure-response modeling

Drug Discovery Support

  • High-throughput ELISA: Binding, potency, and biomarker screening
  • SPR hit ranking: Affinity and specificity profiling
  • Cell-based discovery assays: Target engagement, pathway activation, phenotypic screening
  • PRI & developability: Early HCP/HCD/PAL profiling for candidate selection
  • PK/PD modeling: Rapid LC-MS/MS and LBA platforms for early-stage decision-making

Custom Bioassay Development

We build assays that reflect your drug discovery and development stage:

  • Tailor-made potency assays for MOA and target engagement
  • Mechanism-of-action assays for functional validation
  • Rapid development & qualification for preclinical and clinical phases
  • Scalable platforms for lot release and regulatory submission

Why Choose Us?

ALCOA+-driven quality systems

21 CFR Part 11 & GAMP-compliant labs

End to End Support: Method Development → Validation → Sample analysis → Regulatory support

Diverse platform of instruments and technologies

Integrated safety and quality management systems

In-house scientific expertise across the value chain

Custom assay development with regulatory-ready documentation

Virtual Tour

 

Connect with our scientific experts for your drug discovery, development, and manufacturing needs

We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.

Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.

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