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Tag: Cell-Based Assays

ADCC and CDC Assay: Validation and Optimization

Antibody dependent cellular cytotoxicity (ADCC) is a mechanism in host immune defense where antibodies bind to an antigen on the surface of a cell, targeting…

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Cell-Based NAb Assays: What We Need to Know

Cell-Based NAb Assays So, how do we deal with NAbs when it comes to the industrial production of biotherapeutic agents? The bioanalytical community adopts a…

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Cell and Gene Therapies Account for a Large Portion of the Therapeutics Market

Cell and gene therapies have gone through a growth spurt in the last decade. According to data from the Alliance for Regenerative Medicine (ARM), during…

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CMC Requirements for Cell and Gene Therapy for IND Applications

The U.S. Food and Drug Administration (FDA) has issued Chemistry, Manufacturing, and Control (CMC) recommendations for Investigational New Drug (IND) applications for human investigational gene…

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A Beginner’s Guide to Luciferase Assays

Luciferase is an enzyme used by a variety of organisms for bioluminescence. One of the most common examples of bioluminescence exists in the biology of…

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Impact of Pre-Existing Immunogenicity Against AAV on Gene Therapy Trials

The concept of using pre-existing immunogenicity as an exclusion criteria for gene therapy clinical trials is changing. BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, explores…

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Answering Your Questions on Developing a Relative Potency Assay for an Anti-Influenza mAb

Dr. Jeff Patrick answers questions on how BioAgilytix translated a diagnostic virus neutralization method to a quantitative relative potency assay for an anti-viral antibody.

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Bioanalytical Testing Under GMP: Optimizing Cell-Based Potency Assays

Cell-based bioassays are expected by health agencies as one of the release specification methods for potency assessments in the drug development process. We take a…

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Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype

Today we're featuring a case study on how BioAgilytix developed a cell-based assay to determine the prevalence of pre-existing antibodies against the AAV9 serotype in…

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