Rau Consulting

Expert and leader 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 

Biotech and Pharmaceutical

Process Development to Commercial Manufacturing, CMC Strategy, Biopharma & Industrial Proven experience in setting up development and manufacturing centers of excellence in a global environment. Providing guidance to your team - mentoring them, empowering them with the knowledge required, increasing their skill sets and thus enabling them to achieve their goals whilst providing rapid ROI for your organization.

 

  • Tech Transfer
    Tech Transfer
    Tech transfer is a complex operation carrying business, regulatory, product quality, and technical risks. Each TT case is potentially different and requires a tailored approach. Thats where Rau Consulting can assist and mentor you and your company.
  • Clinical and Commercial manaufacturing
    Clinical and Commercial Manufacturing 
    Commercial manufacturing is characterized by process and cleaning that are operated with full validation, as are the analytical methods. Clinical does not require process, cleaning or analytical methods to be validated
  • Cell and Gene Therapy
    Cell & Gene Therapy  
     With expertise across the cell and gene therapy life cycle our range of approaches will help tackle the challenges you might face in the development of cell and gene therapies. We’ll work with you to accelerate your projects, helping your cell and gene therapies to be safer, more effective, scalable and affordable.
  • Process Development
    Process Development 
    Integrating upstream and downstream process development strategies for a variety of expression systems- mammalian, microbial and cell free. Products include therapeutic antibodies, difficult to express protein and molecules, cell and gene therapies, and exosomes, etc
  • CMC
    CMC
    We have in-depth experience and expertise in developing CMC and manufacturing strategies for large molecule. We have also managed and overseen the CMC development and cGMP manufacturing from pre-clinical into late-stage development.
  • Project Management
    Compliance 
     GAMP 5 - A risk-based approach to compliant GxP computerized systems. The newly revised EU GMP Annex 11 includes an update to 21 CFR Part 11 which brings a more pragmatic approach to compliance in a GMP environment. We can empower your team with the latest that GAMP 5 has to offer.
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Principal Consultant

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

photo of Tiffany D Rau Consultant

Tiffany D. Rau Ph. D

Founder and Principal Consultant

Tiffany - Linked In »

 

 

Expertise 

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  

 
 

 

 

 

 

 

 

Who we are

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

Contact

Rau Consulting, LLC

Email: info@raubiotech.com

Our EU Partner

Bio Pharma Technical Consulting  

link to Bio Pharma Technical Consulting, our EU partner