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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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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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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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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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FDA RACE for Children Act: What You Should Know

Short for Research to Accelerate Cures and Equity, the RACE Act went into effect on August 18, 2020, and significantly increased the number of required…

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CLIA Requirements for Gene and Cell Therapy Programs

It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look…

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Bioanalytical Testing Under GMP: Assuring Biologic Safety & Efficacy via Impurities Assays

We discuss the need to put phase-appropriate methods in place to identify and quantify both process- and host-cell related impurities throughout the drug development process.

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A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals

The FDA recently approved the first gene therapy for pediatric patients with SMA, signifying a major step forward for the therapeutic field as a whole.…

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