Bio Pharma Technical Consulting Ireland Logo

Bio Pharma Technical Consulting

Your Partner in Biologics

Providing strategic solutions and expertise to guide you through the challenges associated with Late Discovery, Early Development, Late Development/Commercialisation, Regulatory Submission to Approval , across all the essential drug development work streams.
Proven experience in setting up development and manufacturing centers of excellence in a global environment.
Based in Cork, serving Ireland and the EU.


  • BPTC  experts in Tech transfer
    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.   more...
  • bptc - experts in Process development
    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  specialists in cell and gene therapy
    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  more...

  • BPTC experts in CMC strategy
    Technology 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 team. more...

  • 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
    GMP 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.   more....

Principal Consultant 

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 in Ireland

Tiffany D. Rau Ph. D

Tiffany -> Linked In »



GMP Project Management
Process Development
Scale-up and Scale down Models
Design for Manufacturability
Process Charactorisation
Bioreactor Development
Global Expertise in CMC, Facility Design & Startup
Regulatory Compliance 
Automation (Pharma 4.0)

Photo of Tiffany D Rau

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 
+353 21 2019726 

 Our US Partner 

Rau Consulting LLC