Session Details

Quality & Operations Track Session 6 - Strategies for instituting materials management program for cell and gene therapy products
Saturday, September 14, 2019 03:45 PM - 05:15 PM 
Ballroom B
Quality assurance for finished pharmaceuticals, biologics, and medical devices includes the specification and control of those components that have product contact during manufacturing, that is, the raw materials. Raw material qualification and control is considered a key factor in assuring the quality of drugs, biologics and devices. Often, raw material testing is not considered scientifically challenging or exciting - until, the supply chain is imperiled by a single failure. Current Good Manufacturing Practices (cGMPs) require that raw material and their suppliers be qualified both initially and periodically. Similar requirements can be found in the US Code of Federal Regulations, ICH guidance, European GMP regulations, and within ISO.

Historically, research and development worked alone when selecting a new raw material. But now a broad team of expertise is needed, due to increased access to unique and complex materials, global sourcing, handling methods, customer locations, and regulations. The topics of the sessions are chosen to cover the most pressing regulatory, technological and industrial challenges facing the raw materials and having an impact on the filling of Biological Licenses (BLA). The content of the session is designed to cover in a balanced fashion both the characterizing the raw materials, as well as the control.

Chair: Aisha Khan, MS, MBA, University of Miami, USA


Potential impact of 21CFR regulations on the control of components used in gene transfer or genomic editing
Robert Lindblad, MD, Production Assistance for Cellular Therapies (PACT), USA
Learning objectives:
•      Understand the regulatory structure related to materials in cell and gene therapy production
•      Understand objectives in developing process and control procedures during production
•      Understand the risks of critical reagents

Raw Material Qualification-Regulatory Perspective
Yong Fan, MD, A2Z Reg Solutions, USA
Learning objectives:
To understand the classification of raw materials based on the intended use, definitions such as drug component, pharmaceutical ingredient, excipient, drug substance and ancillary material, and raw material qualification requirements based on classification/intended use

Where the Rubber Hits the Road – Challenges, Work-Arounds, Compromises and Solutions for Materials Management
Lynn O’Donnell, PhD, Ohio State University, USA
Learning Objectives:
•            Present pre-conference polling results of meeting attendees on various materials management topics
•            Understand the materials management challenges reported by various manufacturers from selection through clinical use
•            Discuss various work-arounds, compromises and actual solutions to materials management challenges
•            Discuss options for push-back and alternate classification schemes of critical materials

Aisha Khan MS,MBA
University of Miami

Yong Fan MD
QC Associate
A2Z Reg Solutions

Robert Lindblad MD
Medical Director
The Emmes Corporation

Lynn O'Donnell PhD
Associate Professor/Director of Cellular Therapy Laboratory
Ohio State University, James Cancer Hospital Columbus