Clinical Trial Support

The IU GTTL can accept DNA, blood or cell suspension for analysis in the following assays:

• Vector Copy Number using Droplet Digital PCR. This assay is capable of providing quantitative analysis of genomic DNA isolated from cells transduced with retroviral vectors, lentiviral vectors, and other DNA sequences of interest. DNA will be analyzed using amplification and quantification of target sequences using specific primers and probe designed and qualified for the target sequence. Samples are analyzed on the BioRad QX200 ddPCR System with QuantaSoftTM Software (Part 11 compliant version). The reactions are multiplexed to determine the DNA content per reaction and allow an estimate of vector copies per cell. The assay is performed under cGMP to meet US FDA requirements.
• Quantitative Real Time PCR Assay for Target Sequence Detection. This assay is capable of providing quantitative analysis of genomic DNA isolated from cells transduced with retroviral and lentiviral vectors. The assay is used for RCR/RCL detection, but additional targets are available or can be designed. The assay is performed under cGMP to meet US FDA requirements.
• Mycoplasma Detection. Testing of cell products for Mycoplasma is available. The assay is qualified to meet European Pharmacopoeia Chapter 2.6.7 (EP 2.6.7) and the Japanese Pharmacopoeia (17th Edition) Chapter G3 (JP G3) requirements of detecting 10 colony forming units per milliliter (CFU/mL) of sample volume. The assay is performed under cGMP to meet US FDA requirements.