(196c) Protein On Demand to Enable “Open Innovation Network” of Drug Researchers
The Centers for Therapeutic Innovation (CTI), a newly created, entrepreneurial Research Unit at Pfizer, Inc. is dedicated to the establishment of global partnerships between Academic Medical Centers (AMCs) and Pfizer to transform research and development through a focus on translational medicine. CTI laboratory staff will include Pfizer employees plus leading basic and translational science investigators and doctoral candidates from the AMCs.
In addition to access to Pfizer’s phage display technologies and antibody research tools, CTI leverages the experience of Pfizer’s antibody purification development and manufacturing platform. We have developed methods for making moderate amounts of antibody, but with a flexibility, speed, and throughput that far exceeds our current platform. These methods have enabled us to go from DNA transfection to 100 g of purified protein in approximately 50 days using traditional cell culture and purification techniques. The final drug substance produced is comparable to material prepared for clinical campaigns using classic methods. Even with these reduced timelines, our high throughput purification development methods allow for development and optimization of key elements in both our upstream and downstream platforms. The purification development is accomplished over five days in parallel with manufacturing of the actual drug substance and includes activities such as evaluation of low pH stability and identification of operating conditions for our weak partitioning chromatography step.
The strategies and technical methods that have enabled timelines measured in days will be presented along with examples of antibodies produced using these approaches. We will compare the process and product quality achieved by this approach to our standard platform and look at issues unique to accelerated antibody production. The potential impact of these technologies on pharmaceutical research will be discussed.