Bringing Pharmaceutical Manufacturing into the Digital Age
Dr. Mauricio Futran
VP, Process Science and Advanced Analytics, Johnson & Johnson
Friday, April 5, 2019
3:00 p.m., 66-110
2:30 p.m. Reception
Abstract:
Pharmaceutical manufacturing must become flexible and agile to deliver tomorrow’s more personalized medicines. Digitization, Modularization and Intensification are critical components for this goal. Our digital approach utilizes multivariate and mechanistic models, electronic recipes, raw material genealogy, that along with sensors lead to real time release, process control and lean technology transfer. Through modularization and automation, we create plug and play environments of mobile operations, connected without revalidating, with integrated automation and maximal use of single-use equipment, flexibly and efficiently delivering to shifting product demands. A critical enabler is a transformational shift in process intensification using continuous manufacturing, high performance cell culture, high capacity resins, simulated moving bed chromatography, etc. This allow smaller production units and enables scale-out approaches. Along with peer companies, we work to transform quality control from being a procedural approach relying on qualification to advanced process control integrated in an overall quality environment.
Bio:
Mauricio Futran is the VP of Advanced Technology in the Global Tech Services group of Janssen Supply Chain at JnJ, focusing on manufacturing process understanding and reliability. This is done by incorporating predictive modeling, in line measurements, data analytics and other technologies into the full range of activities from R&D through scale-up, tech transfer, and life cycle management. The ultimate goal is model predictive control and Real Time Release.
Before joining JnJ Futran was professor and chair of Chemical and Biochemical Engineering at Rutgers University, after working for 28 years in various positions in pharmaceutical product and process development at Merck and Co. and Bristol-Myers Squibb, where he was Vice President of Process R&D. His areas of expertise include process development, technology transfer, validation, regulatory compliance, new product registration, external manufacturing and partnership development.
Dr. Futran is a member of the National Academy of Engineering, where he has been chair of its Chemical Engineering section, and has served on its peer committee, the Board of Chemical Sciences and Technology, and an NRC panel. As an AIChE member he has served on the awards committee. He has been a member and chair of the Princeton Chemical and Biological Engineering external board, and has been a member of the external boards for the University of Illinois at Urbana Champaign, Georgia Tech, and Rutgers.
Dr. Futran has Chemical Engineering degrees from Rice University and Princeton University.