06.30.26 -- Cell Therapy Without The Cells: Building A Therapeutic Secretome

A risk-based framework for identity testing of ancillary raw materials in gene therapy is presented, with emphasis on implementation based on product contact, material classification, and manufacturing stage.

Do stem cells derived from umbilical cord blood belong to the mother or the child? How does the FDA view donor traceability when it comes to pooled donor manufacturing?

Accelerate your AAV production journey. Learn how rapid process development and expert support can streamline your path from vial to purified bulk, ensuring scalable and efficient manufacturing.

Watch to learn how rAAV vectors in gene therapy are addressing manufacturing impurities, risks to patient safety, and analytical methods for detection while aiding sponsors in regulatory compliance.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Larry Brown, Sc.D., chief scientific officer at Noveome Biotherapeutics, to discuss ST266, a first-of-its-kind secretome therapy.

Gain practical insight into scaling human iPSC manufacturing with expert perspectives on process control, reproducibility, and automated workflows designed to support stem cell expansion.