<span>Detection of Antibodies to AAVs Using Gyrolab&reg; System</span>
November 16, 2022

Detection of Antibodies to AAVs Using Gyrolab&reg; System

EBF Open Symposium 2022 -- Adeno-associated viruses (AAVs) are one of most popular and promising tools for gene therapy with several products already approved for treatment of human genetic diseases. Due to natural infection, pre-existing anti-AAV antibodies widely exist in humans and many animal models. This poses hurdles to the AAV-based gene therapy.
<span>New Approach Methods</span>
November 28, 2022

New Approach Methods

In recognition of scientific pursuits to reduce vertebrate animal testing, Labcorp is helping lead innovation in New Approach Methods (NAMs), also known as nonanimal approaches.This includes an array of in vitro test methods and in silico alternatives used to evaluate your substances during early development or to answer regulatory questions.
<span>Human Whole Blood and PBMC-Based Cytokine Release Assays</span>
November 28, 2022

Human Whole Blood and PBMC-Based Cytokine Release Assays

Cytokine release assays (CRAs) are essential in vitro assays for the de-risking of monoclonal antibody therapeutics prior to first-in-human studies. Here we provide performance data for the most popular control compounds in the most popular CRA formats: human whole blood and peripheral blood mononuclear cells (PBMCs).
<span>Our approach to changes in EU IVDR regulation</span>
December 1, 2022

Our approach to changes in EU IVDR regulation

Effective May 26, 2022, the European Union (EU) In Vitro Diagnostics Regulation (IVDR) replaced the In Vitro Diagnostics Directive. This regulation governs how in vitro diagnostics (IVDs) and lab-developed tests (LDTs) are regulated for diagnostic and EU/European Economic Area patient management purposes.
<span>Real-world evidence and Phase IV solutions</span>
December 7, 2022

Real-world evidence and Phase IV solutions

Generating product value is key to market success. Real-world data (RWD) are the basis to generate the right evidence for your value story-aiming to address the needs of various stakeholders like insurance companies, governmental bodies, medical associations and patient advocacy groups.