Posts Tagged ‘Michalle Adkins’

Tracking Cell Therapy Chain of Identity

Posted in Life Sciences, Operations Management on Monday, November 5th, 2018. No comments yet
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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 […]

Moving to Electronic Batch Records

Posted in Life Sciences, Operations Management on Wednesday, May 30th, 2018. One comment so far
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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 […]

Technology Trends for Life Sciences Manufacturers

Posted in Life Sciences on Tuesday, April 17th, 2018. No comments yet
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We seem to be fully in the swing of industry conferences. This week is the pharmaceutical and biotech manufacturing industries’ INTERPHEX conference in New York City. It: …brings over 11,000 global industry professionals and 650+ leading suppliers together to “Learn It, Experience It, Procure It” through a combination of no cost technical conference, exhibits, demonstrations, […]

Data Integrity for Pharmaceutical and Biotech Manufacturers

Posted in Life Sciences, Regulatory Compliance on Tuesday, March 13th, 2018. No comments yet
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Update: This post has been updated with a link to the most recent Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions – March 2018 document. For pharmaceutical, biotech and other manufacturers in highly-regulated industries, the production data is as important as the product itself for release to sale. Data integrity […]

Pharmaceutical Wireless Instrumentation Retrofits

Posted in Life Sciences, Wireless on Wednesday, August 23rd, 2017. One comment so far
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Many industries have benefitted from the use of wireless instrumentation, but how about the pharmaceutical and biotech manufacturing industries? Are there applications which might improve the performance of their operations? In a Pharmaceutical Manufacturing article, Retrofitting Pharmaceutical Processes with WirelessHART Instrumentation, Emerson’s Michalle Adkins and Dan Carlson describe ways that these additional measurements and final […]