The TTDSL assays include cellular and molecular testing categorized as follows:
■Endotoxin ■Fanconi Anemia Complementation typing ■Clonogenic assays (+/- presence of drugs) for enumeration and function
■DNA/RNA Extraction and Quantitative PCR for select vector or genomic sequences ■Clonal contribution studies including vector insertion site analysis and sequencing (LAM PCR) ■Bacterial and Fungal Sterility (Research Only) ■Transgene detection and function assays ■Insertion site analysis (LAM and LM) ■Mycoplasma ■RCR/RCL ■Viral Vector Titration ■ELISA and western blots as techniques we are providing at a CAP level. The laboratory has significant expertise in assays to detect, quantitate, and sequence insertion sites, including molecular detection and tracing of stem cell activity and lineage specific repopulation, surveillance for potential oncogene activation, and other specific molecular safety and efficiency concerns. The Fanconi Anemia Complementation Assay was developed in collaboration with Arleen Auerbach and Helmut Hannenburg and is based on cell cycle arrest correction with complementing retroviral vectors. Assay systems for transplant function and specific transgene correction, including quantitative RNA and DNA molecular analysis, have been developed as a cost-saving modular system that can be combined economically according to the specific needs for each project. The laboratory has the ability to modify research level molecular, cellular, and protein expression testing to SOP driven assays appropriate for support of clinical trials.