Production Featured Articles
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Navigating The Pharma Supply Chain: Balancing Risk And Resilience
10/9/2023
Leveraging an experienced partner with a robust supply strategy can help manage the strain of a supply chain in flux and mitigate risk during the development and manufacturing processes.
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Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations?
10/6/2023
Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.
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Supply Chain Sustainability: Manufacturing Of RSMs And KSMs
10/3/2023
De-risking RSM and KSM procurement can be accomplished via several means, but local sourcing of raw materials and in-house production have proven tremendously effective.
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Three Steps To Digital Transformation In Life Sciences Manufacturing
9/29/2023
Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.
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How To Lose A Batch In 10 Days
9/25/2023
Inspired by the rom com How to Lose a Guy in 10 Days, this article spotlights the critical missteps that could lead you to lose a batch during the manufacturing process. By identifying these pitfalls, the author guides you toward best practices that will not only save your batches but also improve the quality, efficiency, and reliability of your operations.
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Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development
9/14/2023
The FDA now defines a prefilled syringe, a product that was at one point considered “packaging” for a drug, as a constituent part of a combination product. The ultimate combination of the drug, its package, and its delivery device means that during development and manufacturing you need to combine both drug and device current good manufacturing practices (cGMPs) and quality approaches.
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Continuous Processing For Enhanced Monoclonal Antibody Production
9/14/2023
mAbs have only recently been leveraged for advanced bioprocessing techniques. Explore highlights from a webinar where experts discussed their unique collaboration for the continuous processing of mAbs.
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Discover The Intricacies Of Molecular Landscapes Through QMSI
9/13/2023
Explore quantitative mass spectrometry imaging (QMSI) and leading spatial bioanalysis and biology services that offers one-on-one support throughout your drug development process.
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Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture
9/13/2023
Considering the feverish pace of innovation in the field of AI/ML and the inevitable impact on drug development, we outline the documents and guidances that the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.
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Using Media And Feed Panels During Media Development
9/12/2023
Find out how a panel-based approach can help accelerate cell culture media and feed development and maximize the productivity of your biopharmaceutical manufacturing process.