Guest Columns
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The Influence Of Flows In cGMP Architectural Design
8/22/2024
In drug manufacturing facility layout, balancing the roles of layout and procedure plays a critical role. This article examines how the interplay may be resolved, and how this resolution affects facility layout during design.
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NIST, IBBR Researchers Explore Excipient-Influenced mAb Dynamics At Atomic Level
8/16/2024
Nuclear magnetic resonance spectroscopy is powerful technique used to investigate the structure and dynamics of the drug substance in various drug formulations.
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FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA)
8/14/2024
The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.
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This Takeda Official Thinks Pharma 4.0 Won't Be Optional Much Longer
8/14/2024
Advanced technology like automation was once seen only as a competitive advantage. That viewpoint is shifting amid greater reliance on digital technology.
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2024 Emerging Trends In Cleanroom Technologies
8/14/2024
This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.
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VR/XR In Drug Manufacturing: No Longer Sci-Fi
8/13/2024
Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.
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Report: Single-use Bioreactor Uptake Plateaued, Other SUT On The Rise
8/12/2024
BioPlan Associates' latest manufacturing survey found signs of a maturing market and strong demand for innovation upstream and downstream.
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Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection
8/7/2024
This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.
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Improving Viral Safety: Highlights Of ICH Q5A(R2), USP, Ph. Eur. Recommendations
8/6/2024
ICH Q5A (R2) was released in Nov. 2023 and adopted by the FDA and EMA earlier this year. For a fuller assessment of viral control, compendia from the USP and European Pharmacopeia help.
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DSCSA Implementation Is Progressing, But More Complexity May Be Coming
8/5/2024
The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.