Authors
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Ongoing Analytical Procedure Performance Verification—Stage 3 of USP<1220>Analytical procedure performance can be continually verified by risk-based monitoring of performance related data.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Digitalization of QbD Risk AssessmentsQuality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. Their digital transformation can improve efficiency, reduce human errors, and facilitate integration within a much broader digital ecosystem.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
Latest:
Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Analytical Procedure Lifecycle Management: Current Status and OpportunitiesDrawing on practical experience, the authors examine key questions and answers about various aspects relating to the enhanced approach for analytical procedure lifecycle management.
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Enhancing the Solubility of Active Pharmaceutical Ingredients Using Hot Melt Extrusion and Polyvinyl Alcohol (June 2023)This whitepaper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol (Parteck® MXP polyvinyl alcohol 3-82 Emprove® Essential Ph Eur; referred to in this publication as Parteck® MXP 3-82 PVA) can be used to increase the solubility of DCS IIb molecules.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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NIST Fluorescence-Based Measurement ServicesFluorescence has long been used to detect biological targets. As these measurements are becoming more and more quantitative, standards are needed to ensure accuracy and reproducibility.
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Using Digital Tools to Optimize Facility DesignDigital tools, such as building information modeling (BIM) software, improves efficiency for optimizing pharmaceutical facility design.
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WHEATON® Primary Packaging Solutions manufactured by SciLabwareWHEATON® primary packaging solutions manufactured by SciLabware SciLabware Limited, a company of DWK Life Sciences, is one of the world’s leading manufacturers of high quality primary packaging solutions to the diagnostic and pharmaceutical industries across the globe.
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Continuous Processing: Challenges and Opportunities of Virus FiltrationRequirements for virus filtration must be considered in developing continuous downstream processes.
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Ensuring mAb Stability Through ModelingEnsuring the stability of biotherapeutics can be achieved through kinetic models that study aggregation and fragmentation.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Evaluating a New Quality Control Test for Soft Gelatin Rectal CapsulesThis article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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Advanced Analytical Approaches for Accelerated Development of Gene Therapy ProductsDownload the White Paper and learn how detailed characterization can guide successful development of gene therapy products.
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Raising the Bar on Tablet Manufacturing-- Innovations in Tablet Press Technology -- Containment for Tableting: Best Practices -- Direct Tableting a Mixture of a Powder Matrix and API Loaded Pellets
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Spectroscopy Facilitates Lean AnalysisSpectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
