T-Cell Attacks Cancer Cell

Advanced Therapies (ATMP)

Safety and Efficacy Testing of Cell Therapies

An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive into cell therapy programs. If…

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Bioanalytical Support for Gene Therapy Programs

An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of genetic disorders at the DNA…

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Flow Cytometry Assays for Cell Therapy

As we continue our blog series on flow cytometry, we’ll now dive into how this powerful capability supports multiple types of cell therapies. If you…

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How Have Advanced Drug Modalities Impacted Bioanalysis?

...of drug types that are continually evolving and providing room for improvement in bioanalysis.   References: https://www.fda.gov/news-events/expanded-access/expanded-access-compassionate-use-submission-data#EAI https://embioagilytix.wpengine.com/wp-content/uploads/2022/05/AAPS-Journal_Amanda-Hayes-Article_May-2022.pdf Partner With BioAgilytix BioAgilytix is a leading…

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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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Strategies To Overcome Bioanalytical Challenges

Strategies to overcome bioanalytical challenges in Cell & Gene Therapies development With advancements in molecular and cellular engineering techniques, the number of cell and gene…

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Are We Closer to Using the Word “Cures” More Often?

As we look towards the development of the next generation of drugs and therapies, it starts to beg the question of whether we are creating…

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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 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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