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Bio Pharma Technical Consulting

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. Proven experience in setting up development and manufacturing centers of excellence in a global environment. Based in Cork, serving Ireland and the EU.

Your Partner in Biologics 

We provide strategic solutions and expertise to guide you through the challenges associated with Late Discovery, Early Development, Late Development/Commercialization and Compliance, across all the essential drug development workstreams. 

  • BPTC  experts in 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 BPTC can assist and mentor you and your company.
  • bptc - experts in 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
  • BPTC  specialists in 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.

  • BPTC experts in CMC strategy

    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.

  • BPTC epertise in Clinical and Commercial MAnufactuing  for Bio tech
    Clinical and Commercial Manufacturing

    Commercial manufacturing is characterised 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.

  • BPTC - expertise in Project Management deliverables strategy

    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.

Meet our Expert

Tiffany D Rau, Ph. D, Co-owner of Bio Pharma Technical 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 expert on CMC strategy

Tiffany D. Rau Ph. D

Tiffany -> Linked 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

Photo of Tiffany D Rau


Technical management 

Process Development 

Scale-up and Scale down Technology Transfers, DoE 

Metabolic flux analysis 

Kinetic modeling 

Bioreactor development 

Six Sigma- Master Black belt 

Global Expertise- Europe and Asia Ecoli, Yeast, Streptomyces, CHO, Vero Cell therapeutics/stem cells 

Industry Knowledge

Cell Culture 

Protein Chemistry 

Design of Experiments 

Process Simulation 

Six Sigma Assay Development 

Biochemistry Cell Biology 

Research and Development (R&D)

Bio Pharma Tech Consultant 

About BPTC 

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.

Bio Pharma Technical Consulting  
Cork, T23 KW8 , Ireland
Phone: +353 21 2019726
  Our US Partner 
   Rau Consulting  
link to our US partner Rau Consulting