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Antibody Discovery & Development

Preclinical Antibody Testing Services

Preclinical Antibody Testing Services

Preclinical Antibody Testing — IND-Enabling Immunology & Oncology Assays

AVS Bio provides IND-enabling preclinical antibody testing through an integrated workflow that extends from discovery and optimization through to regulatory-ready functional characterization. Preclinical testing is delivered in partnership with RoukenBio, a UK-based immunology-focused CRO.

For clients who have completed discovery, characterization, or optimization work at AVS Bio, preclinical testing together with RoukenBio is designed as a natural program continuation — not a separate engagement with a new vendor. AVS Bio manages the RoukenBio relationship, maintains project context, and ensures continuity of data from lead selection through to IND-enabling studies.

Immune Cell Assays

We offer a comprehensive suite of assay systems that model key immune cell functions and interactions in both health and disease, built on deep immunology expertise.

With a strong emphasis on novel and emerging therapeutic modalities designed to modulate immune responses, these immune cell assays support therapeutic development across immuno-oncology, autoimmunity, inflammation, allergy, and beyond.

We develop in vitro disease models that closely reflect underlying biology, supporting the evaluation of therapeutic candidates in relevant systems that generate robust data for reliable decision-making.

T Cell Assays

In vitro T cell assays provide detailed insights into T cell function, activation, and engineering. Supporting evaluation across multiple therapeutic modalities, the portfolio includes a wide range of assay set-ups, like T cell activation, TDCC assays, T cell polarisation, Treg assays, Gamma-Delta T cell assays, T cell depletion, CAR-T cell engineering, and a highly utilised T cell exhaustion model.

Dendritic Cell Assays

A broad suite of dendritic cell (DC) assays supports immunology therapeutic development, utilizing monocyte-derived DCs or DCs isolated from PBMCs where appropriate. These assays generate comprehensive insights into DC activation, functionality, and their central role in immune responses.

NK Cell Assays

The NK cell assay portfolio enables exploration of natural killer (NK) cell function and therapeutic potential, with models that reflect NK biology in immune surveillance and target-cell killing. These in vitro platforms support assessment of NK cell activity and regulation across stress, infection, and malignancy contexts, and include formats such as NK cell-mediated ADCC (to evaluate antibody-driven target cell killing), NK cell activation and NK cell expansion.

Neutrophil Assays

In vitro neutrophil assays use primary neutrophils isolated from fresh whole blood to assess functional responses relevant to inflammatory, autoimmune, and oncology programs. These platforms enable detailed evaluation of neutrophil activation and effector mechanisms, including phagocytosis, degranulation, migration, and antibody-dependent cellular cytotoxicity (ADCC).

Macrophage Assays

In vitro macrophage assays support drug development by enabling detailed assessment of macrophage function across health and disease. Using monocyte-derived macrophages, distinct macrophage populations are generated and polarised to reflect disease-relevant states, including pro- and anti-inflammatory phenotypes.

Assay platforms support evaluation of macrophage polarisation, phagocytosis, antibody-dependent cellular phagocytosis (ADCP), and interactions with other immune cells, providing insight into therapeutic mechanisms of action across oncology, autoimmune, and inflammatory programmes.

Tumor Cell Assays

Tumor cell assays support oncology research and therapeutic development by providing access to a broad range of immortalized tumor cell lines and bespoke cell line engineering capabilities. These platforms enable the generation or selection of disease-relevant cancer cell targets that can be incorporated into immune cell and co-culture assays to evaluate therapeutic activity in a biologically relevant context. These tailored tumor cell assay systems deliver insights into tumor biology and mechanisms of action, supporting the development and characterization of novel cancer therapies.

Granulocyte Assays

Granulocyte assays support immunological therapeutic development by enabling functional assessment of key granulocyte populations, including mast cells, eosinophils, and basophils. Drawing on deep expertise in granulocyte biology, bespoke in vitro assays evaluate how candidate therapeutics impact granulocyte viability, activation, and immune function. These platforms are particularly relevant to inflammatory, allergic, and immune-mediated disease programs.

Whole Blood Assays

Whole blood assays enable physiologically relevant assessment of immune responses by preserving the full cellular and soluble complexity of human blood. Using fresh whole blood from a large, recallable donor pool with defined Fc receptor genotypes and HLA status, these platforms support phenotypic and functional analyses without the need for prior cell isolation. They are well suited for cytokine release, cytotoxicity, and immune activation studies, providing translational insights into therapeutic mechanisms of action and safety across a range of immunology and drug development programs.

Frequently Asked Questions

Q: What preclinical testing services does AVS Bio offer?

A: AVS Bio offers preclinical testing services spanning immunology and oncology assay panels, including IND-enabling studies. For example, AVS Bio performs ADCC, ADCP and CDC assays to study the functional properties of an antibody. Services are delivered in partnership with RoukenBio and are designed to integrate directly with the AVS Bio antibody discovery and development workflow, providing a continuous path from lead candidate to regulatory submission.

Q: What does IND-enabling mean in preclinical testing?

A: IND-enabling studies are preclinical experiments required to support an Investigational New Drug (IND) application to the FDA before a therapeutic antibody can enter human clinical trials. These studies assess safety, pharmacology, and toxicology under GLP (Good Laboratory Practice) conditions. Completing IND-enabling studies is a regulatory prerequisite for advancing any antibody therapeutic into Phase 1 clinical trials.

Q: What is the relationship between AVS Bio and RoukenBio for preclinical testing?

A: AVS Bio is the contracting party for preclinical testing services, with RoukenBio serving as the specialized subcontractor for assay execution. Clients contract directly with AVS Bio and benefit from integrated project management across the full discovery-to-preclinical workflow. The partnership provides access to RoukenBio’s specialized preclinical capabilities within the AVS Bio program structure.

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