Guest Columns
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Using The ADKAR Model In Biopharma Change Management
7/8/2024
Biopharma companies dedicated to continuous improvement are the ones that dominate their market sector. Using the ADKAR model of change management can help.
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System Failure Mode & Effects Analysis (SFMEA): An Alternative Approach For Analyzing Risks
6/26/2024
Your company likely uses risk matrices and FMEA for analyzing risks. This article describes an alternative approach for conducting a system failure mode & effects analysis.
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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Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance.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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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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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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AI Integration In Drug Manufacturing: GMP Insights For Operational Excellence, Regulatory Compliance
6/4/2024
This article provides insights into a variety of use cases on the application of AI/ML in GMP settings and 5 key considerations for drug manufacturers using AI.
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Is Your Intellectual Property Safe With Indian CROs And CDMOs?
6/3/2024
Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.