Everyone involved in biopharmaceutical manufacturing must keep current with regulatory guidance and technology trends. Finalists in this year’s Readers' Choice Awards manufacturing category look both forward (to the burgeoning potential of bioprocessing 4.0) and back (to the aging facilities that don’t have to be left behind). In the process, the nominees define what is in many ways a transitional period for the industry. Quality by design (QbD) and risk-management principles permeate all these discussions, as should be no surprise.
Brower et al. provide heuristic tools for assessing a biologic's manufacturability and identifying potential for process redevelopment activities within a resource-constrained environment. Chattaway's article makes plain the many factors that can complicate technology transfer from a drug sponsor to a manufacturing partner. Kis describes how emerging software packages for process modeling could help accelerate the development of vaccines in response to global health crises. And Sandle explores 10 risk factors that deserve consideration when drug manufacturers plan to retrofit legacy facilities.
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