Immunogenicity

The State Of The Biosimilars Market

3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a significant number of top-selling drugs…

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Neoantigens Revive Vaccine Opportunities in Immuno-Oncology

Neoantigens are novel proteins that form on cancer cells following the development of mutations in the tumor-cell DNA. These proteins are new to the immune…

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Determining Immunogenicity for CAR-T cell Therapies

Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T cells against cancer cells. CAR-T…

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Challenges for Measuring Immunogenicity of AAV-based Gene Therapies

Gene therapy is a powerful form of treatment that involves introducing genetic material into cells to replace defective genes resulting in the production of an…

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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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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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Answers to Your Questions on Immunogenicity Testing for Biosimilars: Part 2

BioAgilytix’s Todd Lester answers additional questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.

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Questions on Immunogenicity Testing for Biosimilars Answered: Part 1

BioAgilytix’s Todd Lester answers questions submitted by attendees of his recent Bioanalysis Zone webinar on immunogenicity testing for biosimilars.

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Bioanalytical Strategies to Support Biosimilar Programs: How BioAgilytix is Helping to Shape Best Practices

BioAgilytix has been fortunate enough to have several of our team members participate as co-authors on all three AAPS white papers in the series on…

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CRISPR-Cas9 Milestones: The First In Vivo Clinical Trial Is Now Underway in Boston

The first in-human in vivo clinical trial using CRISPR-Cas9 is now open for enrollment; we take a closer look at this genome editing technology to…

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