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Understanding Anti-Drug Antibody (ADA) Assay Design for Biosimilar Immunogenicity
An overview of bridging ELISA formats, confirmatory and titration assays for regulatory-grade ADA detection.
Read articleDenovo Biolabs delivers trusted, high-quality immunological tools — from pharmacokinetics to immunogenicity — purpose-built for biopharma manufacturers, CROs, and translational researchers worldwide.
From early-stage R&D to commercial quality control — browse our catalog of 400+ validated immunological tools.
Quantify biologic drug concentrations in serum and plasma. Validated for preclinical and clinical biosimilar PK studies.
Detect and characterize anti-drug antibodies. Critical for biosimilar regulatory submissions and clinical immunogenicity assessments.
High-purity reference standards and antigens for assay calibration, method development, and biosimilar characterization.
Detection antibodies, secondary reagents, and assay components for in-house ELISA and bioanalytical method development.
Immunoassay kits for clinical diagnostics, supporting routine and research-grade testing in medical laboratories.
Multiplex and singleplex assays for biomarker analysis in large molecule therapeutics research and translational studies.
Whether you're screening candidates or supporting commercial launch, Denovo has the tools and expertise your team needs.
Denovo's PK and immunogenicity ELISA kits are designed to meet the rigorous demands of biopharma R&D, bioanalytical, and QC/QA teams at every stage of biosimilar development.
In vitro characterization, method development, and initial PK/PD studies with our reference standards and recombinant proteins.
Validated PK ELISA kits and ADA detection kits aligned with ICH and regulatory guidance for clinical sample analysis.
Routine immunogenicity monitoring and product quality assessment tools for commercial manufacturing and QC labs.
Serum quantification · HER2-positive breast cancer biosimilar
Anti-drug antibody screening · Bridging ELISA format
VEGF pathway biologics · Validated for serum & plasma
NAb detection · Cell-based and competitive ELISA
High purity · Biosimilar comparability studies
Browse the full catalog with filters by target, application, and phase
CROs require tools they can trust across diverse sponsor projects. Denovo's off-the-shelf and customizable kits minimize method development time and support regulatory-grade deliverables.
Pre-validated kits with fit-for-purpose documentation that accelerate your timelines for sponsor projects.
PK and immunogenicity kits supporting simultaneous analysis of multiple large molecule programs.
Bespoke assay kits developed to sponsor specifications, with performance reports and regulatory packages.
Parallel analysis across multiple biosimilar programs
Bridging ELISA framework adaptable to multiple mAbs
From design brief to validated kit — end to end
Denovo supports academic and translational research teams with reliable immunoassay tools — accessible, affordable, and backed by technical support.
Recombinant proteins and critical reagents for basic biologics research and target validation.
Cytokine, immunoglobulin, and biomarker ELISA kits for translational immunology studies.
Special academic pricing and collaborative research opportunities with IBAB and other institutions.
IL-6, TNF-α, IFN-γ and more · High sensitivity
IgG, IgA, IgM · Serum & cell culture supernatant
Used in academic comparability and characterization studies
Denovo Biolabs is the first Indian company to manufacture pharmacokinetics and immunogenicity ELISA kits for the global biosimilar industry — a distinction backed by over a decade of focused R&D and real-world deployment in India's leading biosimilar programs.
Products from Denovo are used by 6 of the top 10 biosimilar companies in India. This adoption reflects the reliability, sensitivity, and reproducibility that QC, bioanalytical, and R&D teams demand in regulated environments.
Incubated at the Institute of Bioinformatics and Applied Biotechnology (IBAB) campus in Bengaluru, Denovo has deep roots in life science innovation. Our in-house R&D team continuously develops new tools to address evolving industry needs.
Denovo's Make in India mission isn't just about manufacturing location — it's about making world-class immunological tools accessible to Indian and global researchers at a competitive price point, without compromising on quality or regulatory compliance.
From assay development to full bioanalytical support — Denovo's team works alongside pharma, biotech, CRO, and academic partners to deliver results.
Custom ELISA and immunoassay development for novel biologics, including assay design, development, and pre-validation packages tailored to your molecule and matrix.
Talk to our teamEnd-to-end bioanalytical support for PK and immunogenicity testing — method development, validation, and sample analysis for preclinical and clinical programs.
Talk to our teamCell-based and binding assays for potency testing, receptor-ligand interaction studies, and characterization of large molecule therapeutics and biosimilars.
Talk to our teamProduction of custom antibodies, critical reagents, and assay components for proprietary bioanalytical workflows, with batch-to-batch consistency and documentation.
Talk to our teamCollaborative arrangements with academic institutions for tool access, co-development of novel assays, and research support in the area of immunology and biologics.
Talk to our teamSpeak with a Denovo technical specialist. We'll help you identify the right product or service for your specific program, timeline, and budget.
Contact technical supportTechnical articles, news, and updates from the Denovo science team.
An overview of bridging ELISA formats, confirmatory and titration assays for regulatory-grade ADA detection.
Read articleCelebrating over a decade of innovation as India's first manufacturer of PK and immunogenicity ELISA kits for the global biosimilar sector.
Read moreMethod performance data, cross-validation results, and protocol guidance for Denovo's Trastuzumab PK ELISA kit.
Download noteIndian Biotech Industry Recognition
Institute of Bioinformatics & Applied Biotechnology, Bengaluru
Supported under Make in India & Startup India initiatives
Products supplied to international biopharma and CRO customers
Denovo Biolabs was founded in 2013 with a clear purpose: to develop quality immunological tools and biopharmaceutical technologies that make precision diagnostics and biosimilar development more accessible. Incubated at the IBAB campus in Bengaluru, we have grown into India's first and leading manufacturer of pharmacokinetic and immunogenicity ELISA kits for the global biosimilar industry.
Denovo Biolabs established with a focus on immunological tool development for Indian life sciences.
Pioneered the manufacture of PK and immunogenicity ELISA kits for the global biosimilar industry in India.
Denovo tools adopted by leading Indian biosimilar manufacturers for R&D, QC, and regulatory programs.
National recognition for Denovo's contribution to India's biosimilar and life science ecosystem.
Talk to our team, request a quote, or download a datasheet to evaluate Denovo's kits for your specific program.
Whether you have a product enquiry, need technical support, or want to discuss a custom assay project — our specialists are ready to help.