The U.S. Food & Drug Administration (FDA) outlines the drug development process in five steps: Discovery and development Preclinical research Clinical trials FDA review FDA post-market safety monitoring I caught up with Emerson’s Zuwei Jin whom you may recall from earlier posts on the role of automation in the drug development process. Zuwei explained to […]
Cell therapy is when: …cellular material is injected into a patient;[1] this generally means intact, living cells. For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy. For manufacturers in the Life Sciences industry, making these therapies poses challenges since each batch is specific to […]
Author: Jonathan Lustri I have previously been interviewed and written about a process control and MES [Manufacturing Execution Systems] architecture where the batch control logic within the process control system is the single procedural engine. It drives procedural logic and workflows executed by the MES system when called by the process control system. The benefit […]
Yesterday we highlighted advancements in exception management technology for pharmaceutical and biopharmaceutical manufacturers. Exception management is one element in an electronic batch record (EBR). Other elements for the EBR which also have high data integrity requirements include equipment management, material management and batch record process flow and recipe management. In a PharmTech article, Making the […]
Exceptions in batch manufacturing processes are the deviations that occur outside the prescribed specifications. For pharmaceutical and biopharmaceutical manufacturers, quality and manufacturing personnel must review these exceptions. Traditionally, this quality review process occurs after the batch has completed. A recent news release, Emerson Helps Life Sciences Companies Reduce Time to Market with Faster Quality Reviews, […]
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