Implementing a real-time PCR-based method for sterility release testing of ATMPs

Cell therapy development programs generate encouraging pre-clinical and clinical results with the promise that these tailored therapeutics can provide a curative rather than maintenance therapy. Therapies are being developed across the spectrum from academic institutions to small and medium biotechs/biopharma as well as large pharma companies which have all invested significantly in the cell and gene therapy (CGT) field. As additional CGT therapies gain approval, specifically in solid tumors and auto-immunity, the addressable patient populations will grow requiring scaled -out/-up commercial manufacturing. Although the CGT field is experiencing significant tailwinds, challenges remain. Cell sourcing has long been considered a pain-point which is potentially compounded with the necessity to develop robust GMP manufacturing processes and appropriate analytical methods.

Prostate cancer is the second most common cancer and the fifth leading cause of cancer-associated mortality among men worldwide. The use of serum prostate-specific antigen (PSA) to screen for prostate cancer is intended to detect the cancer at an early stage to reduce overall and disease-specific mortality. However, evidence that PSA screening for prostate cancer saves lives is somewhat lacking. Furthermore, there is concern about harm from overdiagnosis and complications from diagnosis and treatments for what may be an indolent disease. The U.S. Preventive Services Task Force recently updated its recommendation statement for PSA-based screening, changing it from a grade D recommendation, which advises against PSA-based screening for prostate cancer, to a grade C recommendation, which advocates for an individualized approach to screening.

Liquid biopsy, utilizing blood as a less invasive alternative for tissue samples, is becoming more and more prominent in precision medicine. The possibility to analyze blood samples across the species matrix makes mass spectrometry-based proteomics a powerful tool for early-stage, translational, and clinical research.

Autoimmune diseases such as ulcerative colitis require chronic treatment that often causes systemic immunosuppression, increasing long term cancer and infection risk. Reducing systemic side effects with localized treatment would greatly benefit patients. This webinar will explore the spatial characterization of oral gut-selective versus systemically available JAK inhibitors in the mouse oxazolone model of ulcerative colitis using the GeoMx™ Digital Spatial Profiler (DSP) from NanoString®.