GAMP5 Annex 11 21 CFR Part 11
Strategies for cGMP
Full life cycle
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.
We provide guidance to your team - we mentor them, empowering them with the knowledge required, increasing their skill sets and thus enabling them to achieve their goals whilst providing rapid ROI for your organisation.
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.
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.
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.
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.
Tiffany D Rau, Ph. D, Co-owner and Principal Consultant of Bio Pharma Technical Consulting and 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
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
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
Cell Culture
Protein Chemistry
Design of Experiments
Process Simulation
Six Sigma Assay Development
Biochemistry Cell Biology
Research and Development (R&D)
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.
