Session Details

Q&O Session 4: Starting & Raw Material Selection for ATMP Manufacturing
Friday, May 29, 2020 03:45 PM - 05:00 PM
Quality & Operations
Starting and raw material selection is an essential aspect that need to be considered for ATMP manufacturing in order to guarantee quality of medicinal products to be used in patients. During this session the most important aspects regarding starting and raw material selection for ATMP manufacturing are going to be reviewed such as:

-Differences in donor eligibility requirements, regulatory aspects to comply during donor selection and ethical considerations
-Critical aspects to consider when using biological raw materials for ATMP manufacturing
-Challenges to consider during vector production and control
-Appropriate conditions to establish and test when using seed lots and cell banks

Speakers:

Global differences in eligibility requirements
Craig Spalding, MBA, Scottish National Blood Transfusion Service (UK)
Across the world, there are various differences in donor eligibility requirements in ATMP manufacturing. These differences stem from a number of factors such as regulatory requirements, ethical considerations and also practical manufacturing considerations. Understanding these differences facilitates logistical decision making, and also successful regulatory submissions.

Critical aspects to consider when using biological raw materials for ATMP manufacturing
Rosaria Giordano, MD, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico (IT)

ATMP manufacturing relies on the availability of biological raw materials and the quality and clinical effectiveness of these medicinal products can be dramatically influenced by the characteristics of the chosen starting materials. Different considerations shall be done for autologous and allogeneic products but there are critical biological, molecular and ethical aspects that must be considered for ATMP manufacturing.

Challenges Associated with Vector Production
Daniela Bischof, PhD, Indiana University School of Medicine (US)

Viral vector products utilized for gene therapy must meet criteria as set forth by regulatory agencies, such as the FDA in the United States.  Obtaining quality products starts with the use of consistent and established raw materials.  This presentation will describe the major processes involved in large-scale lentiviral vector manufacturing and how we have dealt with some of the challenges associated with raw material selection.

Master cell bank generation, viral vector production and testing – the US academic manufacturing experience
Gerhard Bauer, PhD, University of California Davis Institute for Regenerative Cures (US)

In the United States, stringent requirements exist for the quality of a master cell bank for viral vector manufacturing and also for the gene therapy vector itself. Safety of vectors manufactured and their subsequent efficacy in human clinical applications will be the most important outcome by which clinical gene therapy applications will be judged for many years to come.