BIO From The Editor and Guest Columns
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Have We Got Novel Drug Production And Compliance Timelines All Wrong?
6/13/2024
Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.
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Where's The Case For Generative AI In Biopharmaceutical Manufacturing?
6/12/2024
The early use cases for AI in the biopharmaceutical industry—at least, the early public use cases—have largely come from R&D, and more specifically, target identification and molecular design. Where are the use cases in biologics manufacturing, supply chain management, QMS, and operations, and what’s holding us back?
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Managing Change In Vaccine Production With All Stakeholders
6/12/2024
Balancing stakeholder expectations and opinions, and sometimes mitigating disagreements, during a change can prove more daunting than the change itself.
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Design And Function Of GMP Transition Spaces
6/12/2024
In pharma/biotech GMP, there are several spaces that function as transition spaces, such as air locks. This deep dive discusses how procedure and arrangement can influence their effectiveness.
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The Ins And Outs Of Modern Barrier Systems For Sterile Manufacturing
6/10/2024
This article looks at key features of restricted access barrier systems and isolators and discusses some of their applications.
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Beware AI Hallucinations
6/7/2024
As the use of AI increases and expands to new functional areas within biopharmaceutical companies, leaders must understand the risks and mitigate the impact of hallucinations in AI model outputs.
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Does Flow Play A Role in Protein Aggregation During Bioprocessing?
6/7/2024
We know about many factors that trigger protein aggregation, but does fluid flow itself play a part? These scientists at the University of Leeds are working to find out.
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The Growing Demand And Applications For HPLC
6/6/2024
High-performance liquid chromatography offers more features compared to other analytical techniques, and the industry is finding more valuable ways to use it.
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Balanced Sourcing Of Custom Media/Buffer Formulations, Part 2: The Case For Insourcing
6/6/2024
In part 1 of this 2-part series, the authors discussed the case for outsourcing of custom media/buffer formulations. In this article, they discuss key considerations in the case for vertical integration, or insourcing.
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Are Annex 1's CCS Requirements Still Challenging You?
6/5/2024
Contamination control strategies are nothing new, but their inclusion in the Annex 1 update represents one of the revision's few new requirements.