The Data Quality & Master Files Challenge For FDA Submissions

From its beginnings in 2016, Celularity Inc.’s Dr. Robert Hariri knew his company would face a particularly acute challenge with the FDA. The company’s therapeutic approach—the development of medicine from allogeneic placental-derived cells—is entirely dependent on its ability to do something that had never been done before: accomplish the at-scale harvest and preservation of healthy, postpartum fetal stem cells from maternity wards far-and-wide.

That’s not something the FDA would take lightly, and Dr. Hariri knew it. But this wasn’t his first rodeo. He knew that to pass muster with the Agency, Celularity would have to demonstrate a diligent commitment to data quality, master files, and reporting.

Dr. Hariri shared some of his wisdom on the topic during a recent episode of The Business Of Biotech podcast (produced by BioProcess Online in partnership with Cytiva).