GMP raw materials for cell therapy manufacture: what, when and how?
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The cell and gene therapy industry is entering an exciting phase of accelerated growth, which carries many logistics challenges right from the start of the supply chain. Watch this On Demand webinar moderated by leading expert Jean Stanton (Director, Regulatory Compliance, Johnson & Johnson), as she discusses the critical aspects of raw materials for cell therapy manufacture with our expert panel:
- John Tomtishen, Product Steward – Manufacturing Science & Technology, Cell & Gene Technical Development & Manufacturing, Novartis
- Dr Diane Wotta, Senior Director, Quality & Regulatory Affairs, R&D Systems, Inc., a Bio-Techne Brand
- Dr Sadik Kassim, Vice President, Process & Analytical Development. Mustang Bio, Inc
In this webinar they will discuss key aspects of:
- Understanding the quality of raw materials required along the commercialization pathway; cutting through complexity and inconsistency.
- Providing clarity on what GMP really means in the context of raw and starting materials.
- Clarifying when to start using GMP ‘level’ materials and the implications for process development and Cost of Goods.
- Examining the regulatory picture; what are the key guidance variations between agencies and territories?
- Standardisation across the industry; do we need it and can it be achieved?
Jean Stanton, Director, Pharmaceutical Regulatory Compliance, Johnson & Johnson
Jean joined Johnson and Johnson in 2008 within the Pharmaceutical Quality Assurance organization after more than 20 years in the health care industry, at a university-based medical institution, developing cell based therapies. Jean was responsible for leading the integration of cell therapy regulations into J&J’s supply chain. Her current responsibilities are the deployment and maintenance of the R&D compliance program for all GMP aspects within J&J’s Pharmaceutical Sector, which includes the development of the quality and compliance strategies to support all new platforms that are in-licensed or developed within the Pharmaceutical Sector. Jean is currently co-chairing the Parenteral Drug Task Force, developing a Technical Report on the development of a manufacturing control strategy for gene and cell therapy products.
John Tomtishen, Product Steward – Manufacturing Science & Technology, Cell & Gene Technical Development & Manufacturing, Novartis
John is the U.S. Product Steward at Novartis Pharmaceuticals within Cell and Gene Technical Development & Manufacturing in Morris Plains, NJ. In this role, John owns and manages the process knowledge for cell and gene therapy products from late stage clinical development through commercial lifecycle management activities. He serves as the single point of contact within the Novartis network to ensure a seamless flow of knowledge and information across the organization, and works closely with development to drive process improvement activities. John was an integral part of the Novartis team whose work resulted in the first CAR-T BLA approval (Kymriah™- tisagenlecleucel).
Dr Diane Wotta, Senior Director, Quality & Regulatory Affairs, R&D Systems, Inc., a Bio-Techne Brand
Diane is the Senior Director over Quality Control, Quality Assurance and Regulatory Affairs at R&D Systems, which offers approximately 350 FDA-regulated products through both the Diagnostic and Biotechnology Divisions. Her 20-plus year tenure at R&D Systems has provided her with extensive experience working in a science-driven FDA-regulated environment. She has held several positions at R&D Systems including managing the Cell Culture department, which supported the manufacturing of over 13,000 products, and managing the Fill/Finish department, which performed final vialing of over 1 million vials of proteins and antibodies on an annual basis. Concurrently, Diane also managed the Support Services Group, which handled consumable solutions, SDS-PAGE gel manufacturing, and preparation of reusable equipment throughout the company. This varied experience provides Diane with a vast knowledgebase regarding the development, manufacturing and testing of the various products produced by R&D Systems.
Dr Sadik Kassim, Vice President, Process & Analytical Development, Mustang Bio, Inc
Sadik Kassim, PhD is currently Vice President & Head of Process and Analytical Development at Mustang Bio, which is a clinical stage biotech company focused on the development of novel CAR T therapies in partnership with the City of Hope National Medical Center and the Fred Hutchinson Cancer Research Center. Previously, Sadi was head of Analytical Development for the Cell and Gene Therapies unit at Novartis Pharmaceuticals in Cambridge, Massachusetts where he contributed to the BLA filing of CD19 CAR-T therapy (Kymriah) for pediatric ALL and DLBCL. Prior to that, Dr. Kassim was a Research Biologist in the Surgery Branch at the National Cancer Institute (NCI) where he contributed to the CMC sections of several first in human cell therapy clinical trials and participated in the manufacture of CAR, TCR, and TIL based cell therapies. At the Surgery Branch, Sadik helped with the initial development work that led to Kite’s CD19 CAR-T product for lymphoma, Yescarta. A viral immunologist by training, Sadik has over a decade of experience in the development of cell and gene therapies including ex vivo gene-modified cell therapies and in vivo AAV based gene therapies.
