Design of experiments (DOE) is a systematic method to determine the relationship between factors affecting a process and the output of that process. This is essentially finding cause-and-effect relationships. DoE is a powerful tool that can be used for making improvements during process development. It can be used to achieve screen for critical process parameters (CPPs), achieve Six Sigma goals, optimise processes, decrease costs by optimizing yields or reducing process failures. DoE is an integral part of the Quality by Design (QbD) approach and is widely use throughout the biotech industry as well as in other industry sectors.
GRA has extensive experience of applying DoE approaches in the development of biological products both for process and analytical methods. GRA has worked with multinational biopharmaceutical companies as well as small biotech startups including Takeda Vaccines, Ipsen Biopharma, FluGen, Mesoblast and Capillary Film Technology in applying DoE approaches to both novel and existing processes. In addition, GRA also performs training on the application of DoE. GRA works closely with statistical associates in the application and statistical training of DoE to biotech products.
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