Providing strategic solutions and expertise to guide you through the challenges associated with Late Discovery, Early Development, Late Development/Commercialization, Regulatory Submission to Approval, across all the essential drug development workstreams
Tiffany D Rau, Ph. D, owner and Principal Consultant of Rau Consulting 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
Scale-up and Scale down Models
Design for Manufacturability
Six Sigma - Master Black belt
Global Expertise in CMC Facility Design & Startup
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