Computer Software Assurance
Chemistry, Manufacturing and Control
CDMO Solutions
Providing strategic solutions, expertise and bespoke training 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, the EU and the US.
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...
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...
The paradigm shift - CSV to CSA, aims to make the adoption of compliant computerised system tools simpler, more streamlined and more straightforward.
Instead of producing a lot of documentation to validate a digital system, regulated companies should instead adopt an agile and risk-based approach. more ....
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.....
Supplier and Internal Audits
Process Development
Scale-up and Scale down Models
Design for Manufacturability
Process Characterisation
Bioreactor Development
Chemistry Manufacturing and Control
Facility Design and Start-up
Regulatory Compliance
Bespoke Training
ISPE GAMP Ireland Compliant digital solutions & paradigms for the future - Thursday 26th September, Rochestown Park Hotel, Cork.
Tiffany presented - 'Overcoming the OT/automation challenges across Cell & Gene Therapy manufacturing diversities'
