Improving Quantification of Residual Host Cell And Mycoplasma Contaminant DNA For Cell And Gene Therapies With ddPCR™ Technology

All biotherapeutics, whether originating from patient cells or developed in cell lines from bacteria, yeast, plants, insects, humans, or other animals, must be free of contaminants. Mycoplasma is particularly problematic for cell-based vaccines, biologics, and gene therapies and potentially shuts down labs.

Bio-Rad's solutions for biotherapeutic contaminant detection and quantification include software tools that support regulatory compliance with U.S. FDA 21 CFR Part 11 regulations. These tools generate audit trails of protocol changes and use auto-gating and auto-thresholding features to minimize data handling and interpretation.