Featured Bioprocessing Editorial
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Rising Allure And Critical Considerations Of Point-Of-Care Processing
8/1/2024
Mobile and standard cleanroom infrastructures are becoming more popular to meet the logistical demands of personalized medicine and public health emergencies.
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Takeda Cut Its PPQ Timeline With beePFS — Here's How
7/31/2024
The company broke from the norm and used a layered approach — as opposed to a linear one — to develop a new filling line for prefilled syringes of IBS therapy Entyvio.
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Draft Q&A Guidance Offers Roadmap For Biosimilar Post-approval Changes
7/31/2024
FDA explains how it's looking to evaluate the effects changes might have on biosimilar products' identity, strength, quality, purity, and potency.
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A Pragmatic 8-Step Approach To Choose Your Biologic CDMO
7/31/2024
Often, a CDMO partner is selected after a single recommendation or after being approached by a business development representative. There's a more pragmatic way to approach the process.
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The Real Cost Of Poor Quality — And What You Should Do About It
7/30/2024
It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.
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Harnessing Analytics To Minimize Antibody Variants And Speed Up Development
7/30/2024
Antibody heterogeneity comes in many flavors — size and charge variants, and from post-translational changes. To control them, start with thorough characterization.
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Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD
7/30/2024
The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.
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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.