Preliminary Screening in CRISPR-Mediated Gene Therapy
Cells harvested from patients can be genetically modified using CRISPR-Cas9. IDT offers both Research-Use Only (RUO) and cGMP-grade gRNAs.
Selecting cells of a desired phenotype and screening out undesirable cells in a patient sample can prove challenging. Flow cytometry is helpful for immunophenotyping. The Beckman Coulter Life Sciences CytoFLEX Flow Cytometer enables immunophenotyping in preclinical labs. Consider the Beckman Coulter Life Sciences CellMek SPS System for clinical labs to automate clinical flow cytometry sample preparation. Custom reagents and panels can be ordered from Beckman Coulter Life Sciences in DURA dry format for stable storage and can be loaded directly onto the Beckman Coulter Life Sciences CellMek SPS System.
To anticipate regulatory compliance when translating this workflow to a clinical setting, use the Beckman Coulter Life Sciences Navios EX flow cytometer and dry reagents available with IVD-ready certification.
Initial screens of vectors used to modify cells genetically are also crucial for determining success. Screening sgRNA with a SCIEX ZenoTOF 7600 System will evaluate raw material quality and consistency, which will help determine the best sgRNA candidates for genetic modification and further development. Considerations for best candidates include post-modification off-target effects and sequencing specific target regions or loci to assess genomic stability or anomalies.
With the GxP-ready Genedata Biopharma Platform, streamline and automate management, analysis and integration of all screening data essential for CRISPR-mediated gene therapy. This includes analyzing flow cytometry, mass spectrometry and sequencing data, as well as genome-wide gRNA prediction and selection. With the software, register every step in the development of CRISPR-mediated gene therapy, from plasmid production to delivery. Track metadata in IDBS Polar Biopharma Lifecycle Management software.