Advanced Therapies (ATMP)
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…
New Research on the Diagnostic Journey of Patients with Ankylosing Spondylitis
BioAgilytix's Regan Reynolds shares how her own diagnostic journey with Ankylosing Spondylitis (AS) inspired her to participate in a non-interventional research project on how AS…
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…
A Dose of Pharma and Biotech News: December 12, 2019
With innovative research driving pharmaceutical and biotech breakthroughs, industry progress is accelerating at a rapid pace. We've compiled some recent industry articles on the latest…
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…
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…
Gene Therapy Trends: Conditional Approval of Zynteglo Brings Ex Vivo Gene Therapy Into Focus
The recent approval of Zynteglo further builds credibility to the specific and emerging class of cell therapies engineered via “ex vivo” gene therapy. We explain…
The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment
Flow cytometry is an ideal platform for many applications involving the study of complex cell populations. In the first blog of our new “The Fit…
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…
The FDA’s Response to an Increase in the Development of Gene and Cell Therapies: What It Means for Sponsors
...material, gene therapy uses DNA to manipulate a patient’s cells to compensate for abnormal genes or to make a beneficial protein, and cell therapy…