Challenges and Successes in Externalization of the ADC Supply Chain
28th October 2020 | 10:00 am EST | Firelli Alonso, Ph.D., Senior Director, External Supply at Pfizer |BOOK FREE SEAT FOR THIS WEBINAR
Sourcing for the manufacture and control of Antibody-Drug Conjugates (ADCs) used in clinical trials requires strategic planning, establishment of a specialized support network, and execution of several interdependent tasks. ADCs are complex molecules, a fusion of a biological, the monoclonal antibody (mAb), and of small molecules, the linker and the toxic payload. Facilities of acceptable standards for the handling of high potency materials need to be engaged, and there is a limited supply currently. This is further complicated by the fact that there is not one contract facility that has fully integrated services, a “one-stop shop” capable of mAb production, linker and/or payload synthesis, conjugation of mAb to linker-payload to make the Drug Substance, and finally, formulation of the ADC to make the Drug Product. Strategizing the best outsourcing practices for producing and testing ADCs, and establishing guiding principles for externalization to ensure the selection of the right CMOs for ADC outsourcing and technology transfer, will be further discussed.
Presentation by Firelli Alonso, Ph.D., Senior Director, External Supply at Pfizer
Dr. Firelli Alonso is Senior Director, External Supply at Pfizer, Inc. She heads the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. Fi has 25 years of combined experience in research, development, and cGMP production of biological products and vaccines, and 16 years of experience in outsourcing, project & contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and viral vaccine development, recombinant proteins, vaccine process development and cGMP production, project management, technology transfer, and outsourcing.
She obtained her Ph.D. in Microbiology / Virology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University’s Center for Advanced Biotechnology and Medicine. Prior to joining Wyeth / Pfizer in 1996, Fi worked at The Salk Institute-Government Services Division, a vaccine contract manufacturer for the U.S. Armed Forces.