Material Handling Featured Articles
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Key To Formulation Development Is In The Details
7/20/2023
Find out how to face the challenges in tablet manufacturing environments through supportive vendor partnerships.
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Preparing A Framework For Artificial Intelligence And Machine Learning Validation: A 3-Step Approach
7/20/2023
Experts say it would be foolish to ignore the impending AI/ML revolution. There's official guidance out there now on how to prepare, but waiting for a full framework from regulators would be a mistake. This article lays out some strategies for building a foundation to implement AI/ML into your processes.
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Addressing 3 Challenges Using The Tablet Press Automatic Weight Control System
7/20/2023
Three serious issues have arisen in using tablet press automatic weight control systems. For example, we may encounter excessive start-up sampling when manufacturing small batch sizes, resulting in exceeding the maximum allowable loss and triggering an investigation. This expert discusses this point and two other issues.
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Streamline Early-Stage Development To Reach The Clinic Faster
7/17/2023
Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.
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A Micronization Method Enabling The Formulation Of Biopharmaceuticals
6/29/2023
Micronization is key for increasing the loading efficiency and lowering the burst of microspheres. Applying lyophilization-based micronization methodology at a small scale helps to support challenging formulation development projects.
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ICH Q12 Post-Approval Change Management Protocol
6/27/2023
The ICH Q12 guideline includes information about the post-approval change management protocol, which aims to simplify the process of registering site changes under certain criteria through an emphasis on gaining accelerated up-front feedback from the regulator before compiling submissions. Following this protocol reduces the approval cycle by up to six months.
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6 Emerging Trends In Pharmaceutical Tablet Coatings
6/26/2023
Tablet coatings have evolved to play a pivotal role in improving the overall appearance, functionality, and stability of tablets. Here are six emerging trends and a look at the overall tablet coatings space.
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Lost CMC Data In An ALCOA+ World
6/19/2023
As technologies advance, the drug/therapy products we make are becoming more complex, and so are their data fingerprints. This article takes a hard look at the way we currently capture and manage chemistry, manufacturing, and controls (CMC) development and manufacturing operations data, and sheds light on how the document-centric mindset of ALCOA+ is not suitable to support the transition to digital CMC and FAIR data management.
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FDA Seeks Input On AI Adoption In Drug Development And Manufacture
6/13/2023
The FDA released two discussion papers for consideration: Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products and Artificial Intelligence in Drug Manufacturing. The papers identify current and potential areas for AI adoption.
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Detection And Quantification Of Process-Related Impurities
6/1/2023
Finding a partner with the expertise and capabilities to provide solutions for detecting and quantifying process-related impurities ensures the successful development and manufacturing of safe and effective products.