PCR
PCR as a Bioanalytical Tool for Gene and Cell Therapy
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool for gene and cell therapy. …
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…
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…
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…
Validation of qPCR Assays for Gene Therapy
Though the modern world has progressed a lot in terms of medical interventions and biomedicine, there still are a vast number of diseases and disorders…
Update on CAR T-Cell Therapies for the Treatment of Cancer
Chimeric Antigen Receptor (CAR) therapies are a type of cell therapy that consists of modifying immune cells to attack various forms of cancerous cells. While…
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…
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…
The Power of Being NYCE
A recent study using triple-edited ‘NYCE’ cells shows the possibilities of multiplex genome editing to effectively treat complex diseases like some cancers. We explore the…
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…