Posts Tagged ‘biotech manufacturing’

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 […]

Identify and Resolve Cell Therapy Batch Manufacturing Exceptions

Posted in Life Sciences, Operations Management on Tuesday, February 20th, 2018. No comments yet
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We conclude our series on improving cell therapy manufacturing with a closer look at the review by exception process. In the manufacturing process of cell therapeutics, product cycle times are extremely short and any exceptions occurring during the production process must be found and addressed quickly. Emerson’s Bob Schiros notes that manufacturing execution systems, such […]

Managing the Chain of Identity in Cell Therapeutics Manufacturing

Posted in Life Sciences, Operations Management on Thursday, January 4th, 2018. No comments yet
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Medicines produced by pharmaceutical and biotech manufacturers are manufactured in many ways. One particular type of treatment, cell therapy, is defined as: …the transplantation of human or animal cells to replace or repair damaged tissue. From a manufacturing perspective, each therapeutic batch must be perfect the first time — because each batch is produced for […]

Successfully Implementing Process Analytical Technology

Posted in Life Sciences on Tuesday, October 31st, 2017. No comments yet
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It’s been well more than a decade since the U.S. Food & Drug Administration (FDA) announced a Process Analytical Technology (PAT) approach for pharmaceutical manufacturers in their Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. While conceptually understandable, it has taken time for PAT to be put into […]