Guest Columns
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
7/25/2024
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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Is Your Lab Ready For A LIMS Implementation?
7/25/2024
Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.
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How CSL Behring Worked With EMA/FDA To Develop Hemgenix Potency Assays
7/24/2024
Gene therapy products are complicated, and it can be hard to know at which step to measure potency. Here's how CSL Behring did it for Hemgenix.
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9 Common Tech Transfer Pitfalls To Avoid
7/24/2024
Many issues can trip up a tech transfer process. Here are nine of them— plus ways to mitigate each one.
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Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
7/23/2024
In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.
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Uncovering Cell Culture Media's Part In Latest Biopharma Trends
7/19/2024
Cell culture media are ubiquitous in just about every bioprocess system, and advanced modalities are putting specialty media in the spotlight.
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Making Good Decisions When FDA Investigators Come Knocking
7/18/2024
Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
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5 Recommendations To Maximize CSV/CSA Outcomes
7/17/2024
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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How Eli Lilly's Making Peptides Faster And More Reliably
7/17/2024
Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.