GAMP5 Annex 11 21 CFR Part 11
Chemistry, Manufacturing & Control
Full life cycle
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.
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. Thats where BPTC can assist and mentor you and your team. more...
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....
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
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)
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.
