The U.S. Food & Drug Administration (FDA) outlines the drug development process in five steps:
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 me how manufacturing execution systems (MES), such as Syncade MES can be used in research environment to gather and organize the information required for tech transfer through the drug development process.
Many pharmaceutical and biopharmaceutical manufacturers have been probing around the possibility of using MES in R&D and believe it can be very effectively applied when moving into the clinical and commercial production steps.
Zuwei has shared ways to use Syncade MES Equipment Management, rather than Recipe Authoring (RA), to be the main tool to organize the R&D workflow, documents, and materials. While the production environment is generally considered to be product centric where repeated runs for the same product are performed, the R&D environment can be equipment centric where different experiments are run on the same equipment. Therefore, a MES solution for R&D will be based on Equipment Management rather than RA which has been a norm for production.
MES expanding into R&D does not necessarily replace the existing electronic lab notebook solutions. It does however add exceptional capabilities in organizing research workflow, research planning, equipment logbooks, experimental results, etc. This approach also brings in the MES concept early in the drug development pipeline and it serves as a bridge for better and smoother tech transfer through the pipeline.
The Syncade MES Equipment Management solution provides users the capability to define any kind of state/event transitions or event interactions. This is a critical tool for documentation of activities on equipment in a regulated environment. It is also applicable for research activities in R&D in pharmaceutical industry. What makes the Equipment Management solution a great choice for R&D workflow management includes:
Learn more in the Manufacturing Execution Systems section on Emerson.com. You can also connect and interact with other MES and pharmaceutical & biotech industry experts in the MES, SCADA & Other Systems discussion forum and Life Sciences group in the Emerson Exchange 365 community.
The post Manufacturing Execution Systems in Drug Research and Development appeared first on the Emerson Automation Experts blog.
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