Improving Antibody–Drug Conjugate Safety Profiling: The Need For Translational Ex Vivo Models To Assess Hematotoxicity

Improving Antibody–Drug Conjugate Safety Profiling: The Need for Translational Ex Vivo Models to Assess Hematotoxicity

Antibody–drug conjugates (ADCs) hold great promise for targeted cancer therapy, but their clinical success is often limited by hematotoxicity. Traditional models fail to predict these toxic effects with sufficient accuracy, particularly in the human bone marrow. In this post, we explore how Vivia Biotech’s proprietary ex vivo assay provides a translational solution to this challenge. By enabling simultaneous measurement of ADC efficacy and hematopoietic toxicity in a native microenvironment, this platform offers drug developers a powerful tool to optimize the therapeutic index, compare ADC candidates, and anticipate safety liabilities—early and reliably.
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Why Leading Pharma Companies Trust Vivia Biotech For Functional Preclinical Research

Why Leading Pharma Companies Trust Vivia Biotech for Functional Preclinical Research

Leading pharma and biotech companies rely on Vivia Biotech to generate human-relevant functional data early in the drug development process. Using patient-derived samples under native conditions, our ex vivo assays preserve the immune and stromal complexity of the tumor microenvironment—enabling precise evaluation of drug mechanisms, immune responses, and resistance pathways. With more than 190 projects completed, we provide mechanistic clarity and translational insight to accelerate oncology, hematology, and autoimmune disease pipelines.
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From Animal Models To Patient Samples: The Regulatory Rise Of Functional Assays Under The FDA Modernization Act 2.0

From Animal Models to Patient Samples: The Regulatory Rise of Functional Assays under the FDA Modernization Act 2.0

The FDA’s regulatory shift away from animal testing has opened new avenues for preclinical innovation. Functional assays using native patient samples now offer a clinically translatable, ethical alternative for early drug evaluation. Learn how this paradigm is being implemented at Vivia Biotech to bridge discovery and clinical development.
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Why Functional Assays Alone Can Miss Drug Mechanisms

Why Functional Assays Alone Can Miss Drug Mechanisms

In the preclinical phase of drug development, assessing how a compound affects diseased cells is fundamental. Traditionally, this has relied on functional assays that measure outcomes such as viability, proliferation, or cell death. These readouts provide a first indication of drug efficacy, particularly in systems that attempt to reproduce the biological context of the disease.
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