- Understanding GMP production of biologic therapies is a long-term commitment throughout the life-cycle of a product
- Discussing how for CDMOs this includes developing strong relationships with suppliers
- Demonstrating the importance of a solid supplier partnership, from early stages of technology implementation, is essential for long-term success
- Illustrating a successful Supplier-CDMO relationship in action using GE Healthcare and FUJIFILM Diosynth Biotechnologies as an example
- Showcasing how this partnership rapidly added cell culture manufacturing capacity through the implementation of single-use production systems
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Jeff Carter
Strategic Projects Leader
GE Healthcare
Dr. Carter has been a supplier to the bio/pharmaceutical manufacturing industry for over twenty years, and he has been with GE Healthcare Life Sciences since 2005, serving in R&D and Marketing capacities. He has served in R&D, product management, and acquisition integration. His present role as Strategic Projects Leader is to serve as an internal and external voice for evolving regulatory and de facto expectations related to the global implementation of single-use manufacturing. He has been active in organizations such as the Parenteral Drug Association, ASTM E55, and ASME-BPE, and is first vice chair and technical pillar lead of BPSA. He is presently co-leading BPSA efforts, in conjunction with BPOG, to develop best-practice stimuli on single-use Change Notification and User Requirements. Dr. Carter holds a PhD degree from Penn State University in molecular microbiology.