Industry Insights
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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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Breaking Down The FDA Draft Guidance, "Rare Diseases: Considerations For The Development Of Drugs And Biological Products"
7/24/2024
Raj Bandaru, Associate Director in Regulatory Affairs and U.S. Regulatory Affairs Lead at Accenture provides rich context on parts of the recent FDA Draft Guidance.
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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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Rocket Pharma's Modality-Agnostic Approach To Rare Disease
7/24/2024
Rocket Pharmaceuticals’ president, COO, and head of R&D, Dr. Kinnari Patel, discusses the company’s modality-agnostic approach to treating rare diseases.
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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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Extended GCP Training Is A "Must" For Cell And Gene Therapy Clinical Trials
7/18/2024
Cell and gene therapies (CGTs) carry specific challenges and risks, and so all parties need enhanced training to ensure patient safety, data quality, and Good Clinical Practice (GCP) and regulatory compliance.