Featured Bioprocessing Editorial
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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.
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4 Focus Areas To Improve AAV Production Lines
12/18/2023
AAV-vectored drugs can potentially treat population-level diseases. But biopharmaceutical companies will have to get better at producing them in bulk. Here are some areas to focus on.
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WHO’s 6 Principles For An AI Regulatory Framework For Medical Product Development
12/14/2023
In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.
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Understanding CQAs For mRNA/Lipid Nanoparticle Product Development And Manufacture
12/13/2023
BioPhorum recently created a resource of potential critical quality attributes (CQAs) for mRNA products from the early stages of drug development to commercial manufacturing. We asked two of the paper’s authors some questions to explore the key areas in more detail.
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Mapping The Biosimilar Regulatory Landscape In The Middle East
12/13/2023
Countries in the Middle East and North Africa are promising markets for biosimilar drugs, but inconsistent regulations pose a challenge. Here's an overview of regulatory structures across the region.