Cell & Gene Therapy Analysis

Creative Bioarray offers Cell and Gene Therapy Analysis Services using RNA ISH (in situ hybridization) assay. RNA ISH assay plays a pivotal role in Cell and Gene Therapy Analysis by addressing key challenges and opening new avenues for research and applications. This ground-breaking technology allows for the direct visualization and quantification of gene expression in individual cells within their native tissue context.

In Cell and Gene Therapy analysis, RNA ISH assay from Creative Bioarray can resolve several crucial issues:

• Validation of cellular identity: RNA ISH assay is a powerful tool to validate the identity of the cells that have undergone gene therapy, by visualizing the expression of the marker gene post therapy.
• Monitoring gene action and interaction: RNA ISH assay can track the expression of the inserted gene at site after therapy, enabling the understanding of the gene's action and any potential interaction with host genes.
• Safety and Efficacy: RNA ISH assay can be used for direct visual monitoring of viral vector gene delivery and transgene expression ensuring the safety, specificity, and efficacy of the therapy.
• Regulatory Compliance: The precision, sensitivity, and specificity of RNA ISH assay makes it a perfect candidate for supporting regulatory compliance. It aids in proving the safety and precision of gene/ cell therapy during preclinical investigations and clinical trials, helping to meet regulations set by entities such as the FDA and EMA.

Figure 1. The targeting siRNA was detected using the siRNA probe in the siRNA-treated mouse liver tissue samples and not in the vehicle tissue samples using the RNA ISH assay, indicating successful delivery of the siRNA-based therapy. Expression of target mRNA was detected using the RNA ISH assay and appeared significantly reduced in the siRNA-treated tissue compared to vehicle-treated tissue suggesting successful knock-down of the target mRNA expression with the siRNA-based therapy.

Figure 2. IFNg RNA Expression by Infiltrating CD8+ T Cells in Lung Cancer Microenvironment

RNA ISH assay brings the next level of sophistication to the fast-moving field of Cell and Gene Therapy. It aligns itself with the apex of biotechnological advancement, bridging the realms of precision genomics, cell biology, and clinical therapy, ensuring regulatory compliance while illuminating the new frontiers in personalized medicine.

Thus, RNA ISH, with its potential to decipher complex genetic interactions in conjunction with cellular morphological context, plays an indispensable role in the cutting-edge advancements in Cell and Gene Therapy. This adds a layer of credibility and sophistication to the process and practices of gene therapy alike, underpinning core developments in the arena of regenerative medicine, and paving the way for a new horizon in human health.

Cell and gene therapy development requires a comprehensive understanding of the unique aspects of these products in relation to their therapeutic potential and in vivo safety profiles. Biodistribution and viral shedding assays are two critical means by which such safety can be assessed. The methods used and considerations required are both biologic- and product-specific, and demand expertise and experience.

Biodistribution assays are performed to determine the in vivo distribution or localization of a drug product in selected species to support early biotherapeutic drug development.

As stated by the USFDA, "The biodistribution data, coupled with other preclinical safety endpoints such as clinical pathology and histopathology, help determine whether vector presence or gene expression correlates with any tissue-specific detrimental effects in animals." (FDA Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products, November 2013).  This is particularly important in germ-line tissues (i.e. gonads) to determine intertied transmission status.

While some biodistribution studies have been reported, they are far from adequate. Existing studies are generally limited to organ-level resolution without examining other routes of administration. The Cell & Gene Therapy Analysis Services from Creative Bioarray offered can overcome all these problems and help you obtain high-resolution data.

Our Cell & Gene Therapy Analysis services are featured with:

• Measure target at single-cell level
• Visualize gene regulation with morphological context
• Evaluate biodistribution and efficacy of therapy
• Full cGMP facility ready for Cell & Gene Therapy Analysis
• Various cells and vectors, including CAR-T cells, CAR-NK cells, AAV, lentivirus, etc.
• Comprehensive quality assurance process
• Fully characterized to meet regulatory requirements
• Competitive prices
• Fast turnaround time

Cell & Gene Therapy Analysis Tests Available:

With years of experience and a c-GMP-qualified laboratory, Creative Bioarray Cell & Gene Therapy Analysis ensures that your biological production process complies with international guidelines. Guaranteed quality enable us for worldwide partnerships to accelerate innovation.

For more details, please feel free to contact us for project quotations and more detailed information.