Expert and leader in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of bio pharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech
Tiffany D Rau, Ph.D., Owner and Principal Consultant of Rau Consulting and is an expert in bio processing 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 Bio molecular Engineering from the University of Pennsylvania and her Ph.D. in Chemical Engineering from Vanderbilt University.
Proven experience in setting up development and manufacturing centers of excellence in a global environment.
Expertise in:
Human health and animal health and the scientific and regulatory environment
Process development in industrial biotechnology.
Process robustness and reduction of variability ie Design for Manufacturing and DoE
Bioreactor development for microbial and mammalian cell culture.
Pilot plant design and management built to cGMP specifications- Projects greater than $6 million
Multiple biological products currently on market including the 1st Bio similar Insulin (Tech Transfer) and At Scale "Development" and commercial launch material
International process "development" consulting in bio pharmaceuticals, vaccines, and industrial biotechnology - Process Improvements/Optimization and process robustness.
Global scientific and business development/relationship management. Development and Integration of "new" technology into organizations. External Manufacturing and development management Improving product titers using small molecule additives while extending culture viability. Creation of well plate-based cell culture assays for increasing the speed of testing and evaluating in vitro cell cultures and conditions. Connecting MAb production enhancement to the biochemical network for specific productivity. Laboratory and IT project management International Project Management CMO Management
Delighted to have been in attendance at the Bio Process International in Boston. Wonderful to meet and catchup with so many people.
Looking forward to attending CPHI in Frankfurt 1-3 November
Experts and leaders in R&D, process development and commercialization (manufacturing) of mammalian and microbial processes for production of bio pharmaceuticals (API, MAbs, vaccines, therapeutic proteins, cell therapies, enzymes) & industrial biotech
