Lentigen performs numerous in process assays at every step of our cloning and manufacturing process to ensure the quality of our LV products. Lentigen's Quality Control (QC/QA) team will validate by sequencing that the transgene sequence of a custom construct matches those target sequences provided by the researcher. Lentigen also takes many QC measures to ensure our production system is free of any bacterial, endotoxin, or mycoplasma contamination.

Before conducting transduction experiments, the viral titer must be calculated and determined. This could take the researcher weeks to generate feasible cell colonies to determine viral titer. Lentigen will determine the viral titer of your lentiviral particles by either p24 ELISA, Real-Time PCR (RT-PCR), or FACS analysis if a fluorescent reporter is present in transgene target.

Clinical grade LV testing can include, but is not limited to: visual inspection, pH, conductivity, total protein assay, Benzonase ELISA, SDS Page, endotoxin, bioburden, and residual DNA/RNA PCR testing.

It is a regulatory requirement to confirm the absence of any replication competent virus (RCL) for LV products used in clinical testing. The RCL Assay is a biological assay designed to detect potential replication-competent lentivirus (RCL) in supernatant product, transduced cells, final product, and/or end of production (EOP) cells. The vector product is cultured with a permissive cell line for a number of passages and supernatant and cell samples are then tested by p24 ELISA, and real-time PCR. Lentigen can conduct an RCL assay that is validated to the manufacturing scale of the test article being assayed.

Please contact us or call 1-877 (MY-LENTI) to for a custom quote.