Innovation in post licensure manufacturing enabled through process intensification and advanced biologics characterization
Global Head of MSAT, Sanofi Genzyme
Short CV: Luís Maranga serves as the Global Head of Manufacturing Science and Analytical Technology (MSAT) for Sanofi Genzyme, the Specialty Care Global Business Unit (GBU) for Sanofi. Over the past twenty years, Luís has held several senior management positions at Bristol-Myers Squibb, Novartis, Voyager and, more recently, Sanofi Genzyme having the opportunity to do pivotal work in the development, licensure or commercial manufacturing for multiple licensed biologics and vaccines such as Opdivo®,Yervoy®, Orencia®, Empliciti®, FluCelVax®, Celtura®, Optaflu®, and Nexviazyme™, just to name a few. He has also been responsible for the development of over one hundred investigational clinical product candidates in biologics, vaccines, and gene therapy modalities. A cell culture engineer by training, Luís holds BS and PhD degrees in Chemical Engineering from Instituto Superior Técnico and Universidade NOVA de Lisboa, respectively.
Abstract: Manufacturing processes for licensed biologics are often suboptimal due to the use of old and antiquated technologies, limited at-risk investment before clinical proof-of-concept, or accelerated clinical development timelines that do provide enough time for best-in-class process development before licensure is achieved. After licensure, manufacturing changes are heavily regulated, costly as they may require additional clinical trials, new process validation, and are often complex to navigate. Strong process and product understanding, coupled with advanced biologics characterization methods, are critical enablers for the successful development and implementation of beneficial process changes into the post-licensure manufacturing lifecycle of a product. Sanofi has embarked on a journey to improve the manufacturing processes for multiple licensed products. Sanofi has implemented successfully process changes ranging from: high expression cell lines, highly productive fed-batches, or intensified continuous biomanufacturing processes for highly complex recombinant proteins. These changes have been supported by
advanced protein characterization and have enabled successful regulatory filings without requiring additional clinical trials. The scientific approaches that underpin some of these technical achievements will be described.
HOST: Paula Alves