Bio Pharma Technical Consulting Ireland Logo

Biotech Consultancy 

 

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 centres of excellence in a global environment.
Based in Cork, serving Ireland and the EU.

Our Services  

  • BPTC Chemistry Controls and Manufacturing Ireland and the EU
    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.   more...
  • bptc - consultants in Cell and Gene Therapy Ireland and EU
    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 consultancy in process decelopment for Ireland and The EU
    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 consultants for Tech transfer Ireland and the EU
    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. that's where BPTC can assist and mentor you and your team. more...

  • BPTC epertise in Clinical and Commercial Manufactuing Ireland and EU
    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 - GMP Compliance consultants Ireland and The EU
    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.    

Tiffany has also 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.

Tiffany has recently been appointed Adjunct Professor in the School of Biochemistry and Cell Biology at University College Cork where she is currently lectures on a part time basis. more.....

Photo of Tiffany D Rau expert on CMC strategy in Ireland

Tiffany D. Rau Ph. D

Tiffany -> Linked In »

 

Specialties

Supplier and Internal Audits
Process Development
Scale-up and Scale down Models
Design for Manufacturability
Process Characterisation
Bioreactor Development
CMC
Facility Design & Start-up
Regulatory Compliance 
Automation

Photo of Tiffany D Rau
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About BPTC 

Biotech consultancy providing expertise in CMC, Cell and Gene Therapy, Process Development and Commercialisation, Compliance and Technology Transfer

Contact 

Bio Pharma Technical Consulting  
Cork, T23 KW81, Ireland
contact@bptc.ie 
 

 Our US Partner 

 
Rau Consulting LLC