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Immunology Services

During drug discovery and development, it is essential to understand and define how molecules interact with the immune system. As a drug moves through the discovery process, AmplifyBio’s scientists use information and insights gained through immunology and immunotoxicology assessments to provide vital support and strategic guidance for any drug development program from discovery to clinical.


Immunogenicity poses a significant concern for biologic drugs, potentially impacting safety and effectiveness. When considering immune-mediated adverse effects of biological drugs, a comprehensive understanding of the interplay between adaptive and innate immune responses is paramount. Therefore, finding a partner capable of supporting your immunogenicity testing strategy and keeping it up to date with stringent safety and regulatory standards is imperative. At AmplifyBio, our team understands the complexities of the immune system that can affect a product’s pharmacokinetics, pharmacodynamics, safety, and efficacy.

  • ELISAs to measure anti-drug antibodies (ADAs)
  • Cell-based assays for neutralizing antibodies
  • Cytokine arrays to measure therapy-induced responses
  • ELISpot to measure the induction of T or B cell responses to the therapeutic drug
    • T Cell ELISpot enumerates cytokine-producing T cells (IFN-γ, TNF-α, Granzyme, IL10)
    • B Cell ELISpot enumerates antibody-secreting B cells (IgM, IgG, IgA, Ig subtypes)
  • Complement activation assays
  • MHC multimer staining and enumeration to measure induced antiviral or anti-cancer T cells
  • Immunophenotyping by flow cytometry that includes qualified panels (lineage identification) and high parameter panels (> 20 parameters) for discovery applications
  • Animal vaccine models
  • Cytokine secretion assays
  • Leukocyte proliferation assay
  • Complement activity assay
  • Gene therapies and viral vectors
  • Protein drugs
  • mRNA drugs
  • Vaccine candidates


Immuno-oncology demands advanced models and precise endpoints for effective studies. While the basic strategy aligns with non-immune modulating drugs, immuno-oncology studies often necessitate more sophistication to provide valuable decision-making data. AmplifyBio, equipped with expertise in relevant models and a state-of-the-art animal facility, supports the entire product improvement lifecycle, from refinement to manufacturing changes. We utilize proprietary bioinformatics resources to link in vitro product characteristics conveniently tested in-house with in vivo performance and safety insights.
  • Efficacy models, ie. Tumor models
    • Animal tumor models to assess tumor killing/ therapeutic potency
  • PK/PD models 
  • Mechanistic models, ie. Transgenic animals
  • Humanized models
  • Biodistribution
  • Targeted antibodies and/or checkpoint inhibitors:
    • Functional screening assays (Reporter cell line assay, T cell activation assay, cytotoxicity assay, cytokine release assay)
  • Cell product discovery and characterization—genotype, phenotype, function, off-purity potency
  • 3D tumor spheroids with/without PBMCs
  • Cancer vaccines
  • Antibody-based therapeutics, including bispecific antibodies


Even therapeutics with mechanisms of action independent of the immune system can have off-target effects on immune function. As such, it is crucial to identify potential modulation of the immune system and de-risk compounds during the drug development journey. AmplifyBio offers a wide variety of immunological tests that can be tailored fit for purpose and expertise. Our scientists will work with you to collaborate on projects to share data and ideas, altering the plan as needed. Amplifybio can also onboard the customized assays for use in the study and a plan to collect data for future use in generating models.

  • Immunophenotyping (immune cell compartments)
  • Hematology (blood constitution and function)
  • Histopathology: lymphoid tissue morphology and special stains
  • Mouse models: TDAR, Delayed-type hypersensitivity assay (Type IV, T cell-mediated), etc.
  • Function: Cytotoxicity Assay, MLR, Cytokine response assay
  • Growth: Proliferation
  • Survival: Apoptosis
  • Cell-specific assays:  T cell, NK cell, DCs, Mo/Macs
  • Single pathway analysis using reporter cell lines
  • Small molecule drugs, chemotherapies
  • Oligotherapies

Immune Monitoring

Even therapies with mechanisms of action unrelated to the immune system can induce off-target effects on immune function. Therefore, detecting potential modulation of the immune system is essential to mitigate risks associated with compounds throughout the drug development process.

AmplifyBio boasts the expertise and an extensive technology portfolio spanning basic discovery research to precise immune monitoring applications. Our methods are qualified and standardized across all AmplifyBio sites to ensure accuracy and reproducibility.

  • T and B cell ELISpot
  • Serum Cytokines
  • Complement activation
  • Antibody ELISAs/ Isotyping/ Neut Ab
  • Immunophenotyping/gene expression panels
  • Cell product biodistribution/ serum PK by flow cytometry or dPCR
  • Vaccines
  • Cell Therapy
  • Gene Therapy

Contact Us

Comprehensive service programs for developing Cell and Gene Therapy (CGT), mRNA, and other advanced therapies from concept to commercial and offering expertise and support in discovery, characterization, preclinical CRO safety testing, and scalable manufacturing in an integrated, innovation-rich environment that exceeds the value proposition offered by traditional CDMO and PDMO contract models.