Application of High Throughput and Automated Workflows to Large Molecule Formulation and Process Development
12:00 - 12:35
As the design space for formulation design becomes more complex and the need for accelerated product development more urgent, traditional approaches do not provide a sustainable means to handle such challenges.
Modern development tools that minimize material requirements and maximize use of automation can help overcome these challenges and provide a differentiating capability to rapidly explore large formulation design spaces for novel modalities.
Case studies will be presented demonstrating application of these technologies to tackle various drug product development challenges. New approaches to data analysis and visualization leading to effective decision-making will also be covered.
Nitin Rathore, Ph.D., is a Director of Formulation and Process Technologies function within the Process Development organization at Amgen Inc., Thousand Oaks, California. Dr. Rathore has expertise in the area of formulation, fill & finish and delivery including process characterization, scale-up and technology transfer of early to late stage biopharmaceuticals. His group focusses on development of liquid and lyophilized protein drug products as well as on advancing next-gen technologies in support of product development, manufacturing and commercialization. He has authored numerous publications including original research articles, book chapters and scientific presentations on drug product development. Dr. Rathore received his Ph.D. degree in chemical and biological engineering from University of Wisconsin-Madison, Madison, WI.