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Pharmaceutical Technology, November 2023
Considering the Promises of Point-of-Care Manufacturing
November 03, 2023
Cover Story
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Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.
Pooling of Batches for Stability Data Analysis
November 03, 2023
Peer-Review Research
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One of the main purposes of stability testing is to establish shelf life for these drug products. The goal of this paper is to create an Excel spreadsheet, which can be used for statistical testing of more than three stability batches for poolability.
Predictive Modeling for Formulation Development: Coformers, Cocrystals, Complexes
November 03, 2023
Development
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Predictive modeling facilitates the identification of coformers, cocrystal components, and complexing agents.
Market for Packaging Continues to Expand
November 03, 2023
Manufacturing
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Interest grows in AI, digitalization, robotics, and sustainability.
Gleaning Scale-Up Lessons from mAbs for Viral Vectors
November 03, 2023
Manufacturing
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Monoclonal antibody and viral vector manufacture share similarities, but vector scale up faces unique challenges.
Differentiating Particle Size and Shape Information in Drug Products with Multiple Components
November 02, 2023
Analytics
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Using image analysis to characterize complex finished products is crucial in particle analysis.
Breathing Easier
November 02, 2023
From The Editor
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A novel approach for safety assessments in inhalation drugs may avoid animal testing for drug products.
The EU AI Act
November 02, 2023
Regulatory Watch
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The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.
Best Practice Tech Transfer Methods for CGTs
November 02, 2023
Outsourcing
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A look at using best practice tech transfer methods for CGTs to increase process and analytics robustness while being scalable.
Frontrunners in Next-Generation Radiotherapeutics
November 02, 2023
European Frontrunners
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New radiotherapeutic agents are making headway in hard-to-treat cancers.
Elicitation of Expert Knowledge and Probabilities for Controlling Subjectivity in Risk-Based Decision Making
November 02, 2023
Special Report
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More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.
Capitalizing on Success
November 02, 2023
From the CEO
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Industry investments indicate increasing trust in the newest modalities, including mRNA approaches.
Using a Third Party to Perform Audits
November 02, 2023
Ask the Expert
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There are key elements that should be covered when dealing with third-party auditors, according to Siegfried Schmitt, vice president, Technical, at Parexel.
Digital Valve Controller
November 02, 2023
Product Spotlight
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Fisher FIELDVUE DVC7K combines patented technology with real-time analytics to provide real-time awareness of valve health.
ROSS Reconditioned Mixers
November 02, 2023
Product Spotlight
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ROSS’ reconditioned mixers are restored to “like new” working condition by the ROSS OEM team and are designed to perform at the same standard as brand-new equipment while offering cost savings.