Gene Therapy Characterisation and Release Testing

To help our clients overcome the challenges of gene therapy analytical development, which include characterisation, quality control, and the need to meet increasingly demanding regulatory expectations, we have adopted powerful, advanced analytical tools such as: Analytical ultracentrifugation (AUC) and cryo-TEM to determine full or empty capsids Next-generation sequencing (NGS) to confirm on-target/off-target effects, or to check whether a viral sequence has been correctly integrated into a cell line Sequencing through difficult inverted terminal repeat (ITR) regions of adeno-associated virus (AAV) can also be achieved Using droplet digital PCR (ddPCR) for residual DNA or viral titres Protein purity analysis of AAV capsids by CE-SDS, with sensitive Laser Induced Fluorescence derivatization LINK: https://www.intertek.com/pharmaceutical/biopharmaceuticals/gene-therapy-characterisation/