Featured Bioprocessing Editorial
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A New Year’s Resolution Suggestion For The FDA
1/22/2024
Many pharma/biotech companies have continuing compliance problems when getting inspected by our friends at the FDA. In this article, this industry observer with almost 50 years of experience shares some New Year's resolution wishes for the FDA, and, by extension, industry members can consider the list as the foundation for sustainable quality in your operations.
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Need To Improve Your Change Management? Regulators Can Help With That
1/12/2024
The path to successful change management in drug manufacturing can be pocked with bottlenecks. Here are some tactics you can use to avoid them.
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Is FDA’s COVID Container Closure System Guidance Useful Post-Pandemic?
1/9/2024
The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.
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Are Single-Use Technologies Always The Answer?
1/9/2024
It is clear that single-use technologies (SUTs) have won the war over reusable stainless steel. However, beneath the surface, there is a web of considerations that challenge the belief that SUTs are unequivocally cost-effective. Let's look at cost considerations as well as risk considerations.
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Cell & Gene Therapies: How Can Our Knowledge Of 2023 Inform Our Predictions For 2024?
1/8/2024
2024 promises a potential turnaround and blue skies for cell and gene therapies. Let’s explore each modality’s prospects: oligos and mRNA, cell therapies, and viral gene therapies.
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How To Use Precipitation, Not Protein A Chromatography, For mAb Capture
1/4/2024
Protein A chromatography is a key bottleneck in mAb manufacturing. Precipitation, an early separation technique, has emerged as a ready solution for continuous manufacturing.
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Cryo-Shippers: Challenges, Controls, And Logistics
1/3/2024
Cryo-shippers are essential for shipping advanced therapeutics, but how do you choose and validate the right one? This article from BMS experts offers insights.
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Strategies For Minimizing The Impact Of Bioburden And Sterility Testing On Gene Therapy Batch Yield
1/2/2024
It is widely recognized that gene therapy manufacturing processes result in low yields. This article outlines strategies for reducing the volumes required for bioburden and sterility testing and, therefore, conserving product for patients while remaining compliant and delivering process information on the microbiological status.
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Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 3
12/20/2023
This is the third article in a series of three articles. It continues the discussion of measurement system analysis using continuous gage R&D studies by sharing a generic example using Minitab. Study setup, the role of the study director, analysis, and case studies are examined.
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To Thrive In A Highly Regulated Manufacturing Environment, Improve Your Flexibility
12/19/2023
It sounds counterintuitive. After all, industry must put (often rigid) rules into place to govern manufacturing processes and ultimately protect the integrity, efficacy, and safety of products. But by adopting process discipline to become more agile, you'll be able to respond to changes more quickly.