A cell therapy media fill protocol for validation of aseptic processing of cord blood

Cell & Gene Therapy Insights 2020; 6(10), 1529–1537


Published: 24 November 2020
Methodology Paper
Faith DeDino, Kim Vincent, Denise DiNello, Susan Whitmer, Michelle Adamo, David Starkey, Kara Evans, Molly Walker, Dawn Thut, Sara Shields, Wouter Van’t Hof

We present the design of a media fill study protocol using sterile growth medium in place of cord blood for validation of aseptic processing. Growth media are pre-qualified for ability to support growth of relevant microorganisms as visualized in media turbidity assays. Annual completion of media fills are required for all active processing staff to verify use of proper aseptic techniques, executed under ‘worst-case’ conditions stressing the system. Dynamic environmental and personnel monitoring is included to detect actual contamination risks during the media fills. After processing, all simulated products and controls are incubated and examined for media turbidity. The acceptable failure rate (i.e. observation of turbidity) is defined as zero (0%). All media fills were completed without any failures. Personnel monitoring showed presence of known microbes. These findings demonstrate that the inherent risk for introduction of bio-contaminants, expected to be present during processing, is adequately controlled at CCBC for production of HPC, Cord Blood.