Biotech consultancy supporting
biopharmaceutical development globally
GreyRigge Associates or GRA is a biotech consultancy company that works internationally helping both small and large biopharmaceutical companies to develop their medicines. GRA offers both technical and commercial support for biotech products such as vaccines, cell therapies, monoclonal antibodies, gene therapies and diagnostics.
GRA offers both consultancy and training services to clients covering CMC, process and analytical development, formulation of biologics and pre-clinical and clinical assay development. GRA also have experience in product characterisation and supporting the CMC elements of regulatory submissions and interactions. GRA applies QbD practices to processes, advising on appropriate use of DoE. Please contact GRA on how we might help.
Process development – including process design, optimisation through to validation
“Lee’s vast experience in CMC aspects helped us to make the right decisions at critical stages of the project”
Dr. Matthias Mullner
Head of Manufacturing and Quality
Themis Bioscience GmbH
Conducting well-designed structured studies is important when formulating any vaccine. For live viral vaccines, some challenges include limited analytical tools and inherent variability that make evaluation difficult.