Session Details

Q&O Session 2: Manufacturing Process Validation – considerations for validation of autologous products
Thursday, May 28, 2020 03:45 PM - 05:00 PM
Quality & Operations
Process Validation – it has to happen! Join us to hear regulatory perspectives and real-world examples of considerations specific to autologous products, including both cells and tissues. Are normal donor cells ok to use? What risks are associated with validating your process using cells or tissues from healthy donors?

Validation of the process for autologous vs allogeneic products and tissue products
Antonio Ruiz Garcia, MPharm, Hospital Universitario Virgen de las Nieves (ES)

Process validation is the documented evidence that the manufacturing process can consistently produce a result within specific parameters, that in the particular case of ATMPs the aim is to demonstrate that the finished product characteristics are within a given range. The limited availability of the cells / tissues which is typical for most ATMPs requires the development of pragmatic approaches, that has some differences between autologous and allogeneic products.