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Good Regulatory Practices are internationally recognised processes, systems, tools and methods for improving the quality of regulations. As specified by WHO, GRP aims at making sure that regulations are fit for purpose and will deliver what they are set out to achieve in terms of policy objectives…
With increasing numbers of cell and gene therapy products in development and entering commercialization, more and more sponsors are facing a unique set of challenges of developing bioassays for cell and gene therapy products…
Analytics play a critical role in assuring product quality through release testing, process control, deep characterization, defining critical quality attributes, comparability and analytical similarity…