Experts and leaders in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of biopharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech. Proven experience in setting up development and manufacturing centers of excellence in a global environment.
Tiffany D Rau, Ph.D, Co-owner and Principal Consultant of Bio Pharma Technical Consulting and is an expert in bioprocessing and a Six Sigma Master Black Belt. Her international technical and managerial experience extends from development to post-commercial cGMP manufacturing.
Dr. Rau has been instrumental in designing and leading initiatives to bring R&D and manufacturing together to increase speed to market and minimize technology transfer challenges. Dr. Rau has been the advisor on over 100 different projects in the areas of process intensification, scale-up, variability reduction, and continuous improvement for both mammalian and microbial expression systems
Previously, Dr. Rau has held leadership positions at Evonik-Degussa, Eli Lilly, Pall and GlaxoSmithKline all focused in process development, tech transfer, commercial manufacturing, and CMC strategy. Dr. Rau has over 75 invited speaking engagements focused on delivering current and next-generation products from R and D to commercialization/post-commercialization. Tiffany is also active in the scientific community and is Program Chair for the Recent Advances in Fermentation Technology meeting (2015-2019) and has organized numerous sessions at the SIMB National Meetings (Society of Industrial Microbiology and Biotechnology) and ECI Cell Culture Engineering meetings. She was also part of the inaugural organizing team for ECI’s Microbial Engineering Conference in 2018 and continued on the organizing committee for 2020.
Tiffany is involved in academia and was part of the University of Pennsylvania’s Capstone engineering program for many years as well as Vanderbilt University’s Capstone program where she was the first industrial participant. She is also on Vanderbilt’s Chemical and Biomolecular Engineering External Advisory Board. Her students' work in the past has focused on designing manufacturing facilities for biotechnology processes, for example, regenerative medicine, cell therapies, MAbs, and vaccines. AICHE’s National Design Competition Committee is chaired by Tiffany and she is part of the organizing committee for ACS/ESBES International Biotechnology Design Competition.
She is also an editor of the Journal of Industrial Microbiology and Biotechnology (JIMB) – Special Issues. Tiffany earned her BSE degree in Chemical and Biomolecular Engineering from the University of Pennsylvania and her Ph.D. in Chemical Engineering from Vanderbilt University.
Scale-up and Scale down Technology Transfers, DoE
Metabolic flux analysis
Six Sigma- Master Black belt
Global Expertise- Europe and Asia Ecoli, Yeast, Streptomyces, CHO, Vero Cell therapeutics/stem cells
Design of Experiments
Six Sigma Assay Development
Biochemistry Cell Biology
Research and Development (R&D)
Experts and leaders in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of biopharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech.