BIO From The Editor and Guest Columns
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Manufacturing CAR-T In Vivo
7/25/2024
Manufacturing chimeric antigen receptor (CAR) T-cell therapies is a costly and complicated process. Interius BioTherapeutics is on a mission to reduce this complexity and get these therapies to patients faster — by manufacturing CAR cells in patients' bodies.
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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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Temperature & Containment Controls In ADC Manufacturing
7/19/2024
During a Bioprocess Online Live discussion with leaders from a couple of biotechs with Phase 1 ADC assets in the clinic, an audience member asked questions about OEB (occupational exposure bands) and managing the elevated temperatures required of ADC conjugation. We couldn't address them on the call, but here are some resources that might be helpful.
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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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The Path To Producing An Insulin Biosimilar
7/17/2024
I met with rBIO co-founder and president, Cameron Owen, as well as its CSO, Dr. Deenadayalan Bakthavatsalam, to learn about what it takes to develop an insulin biosimilar. They candidly told me about the company’s plan of execution, as well as how challenging it is to scale-up manufacturing to a commercial level (in the ballpark of several metric tons per year for insulin) — which is the company’s primary focus right now.