Guest Columns
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Chugai's Race To Zero Emissions At UK4 In Tokyo
6/21/2024
Chugai's sustainable model led the construction of a new DS/DP manufacturing site, UK4, in Tokyo. The company focused on eliminating three key emissions sources.
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How Mechanistic Modeling Eases Wet Lab Dependence
6/20/2024
Mechanistic modeling mimics process steps in a computational environment, thereby substantially reducing the dependence on physical experiments.
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What Does FDA's Draft Platform Guidance Mean For CGT Companies?
6/17/2024
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
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How Generative AI Could Change Pharmaceutical Manufacturing
6/14/2024
Despite the hype, pharma has been slow to integrate artificial intelligence. Other industries have shown how it adds value by simplifying tedious tasks.
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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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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.