QbD & Method Development

Explore comprehensive articles on pharmaceutical QbD and method development. Get expert insights on analytical validation, DoE, and ICH guidelines to streamline your drug development lifecycle.

A laboratory scientist operates a compact GC–MS system on a stainless-steel bench, demonstrating modern, space-efficient analytical instrumentation designed for fast, reliable testing in industrial or research environments.
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Compact GC–MS systems are revolutionizing the landscape of analytical testing. Mike Collins discusses how advancements in design and ease of operation are fueling this transformation.
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This article explores LC–MS/MS and immunoassay approaches, validation protocols, and QA/QC strategies supporting robust exosome biomarker assays. 
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A technical overview of sheath-flow and sheathless interfaces, optimization strategies, and future directions in analytical science.
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Understand how hydrodynamic volume governs molecular weight separation in SEC for accurate biopharma QC and aggregation analysis.
Molecular diagram demonstrating analyte separation by MEKC, depicting how hydrophobic, polar, and charged molecules interact with SDS micelles for complex separations.
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Micellar Electrokinetic Chromatography: A Workhorse for Complex Separations

Close-up of a gas chromatograph inlet.
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GC Pressure Errors in Splitless Injection: A Guide to Purge Flow

A laboratory setup with an operating ultracentrifuge on the left and a size-exclusion chromatography (SEC) system actively separating blue liquid into test tubes on the right, illustrating key extracellular vesicle isolation methods.
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Ultracentrifugation vs Size-Exclusion Chromatography: Optimizing EV Purification in Biotech and Pharma Labs

A capillary electrophoresis machine sits on a lab bench, displaying a scientific graph. Two lab technicians work in the background of the laboratory
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Capillary Electrophoresis: Modern Variants and Core Method Strategies 

Detailed microscopic view of numerous cells and vesicles, illustrating the complex biological environment from which exosomes are separated using exosome isolation protocols.
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Exosome Isolation Protocols and Quantification Guidelines

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Comprehensive LC-MS Workflows for Antibody Drug Conjugate (ADC) Analysis

Laboratory technician analyzing airflow paths with a tablet
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Visualizing Safe Airflow Paths in a Laboratory

LC-MS chromatogram of indole-3-carbinol showing double peaks
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Troubleshooting Double Peaks in Indole-3-Carbinol Chromatography

A chemist preparing a sample for injection into a GC-MS, a process crucial for analytical troubleshooting.
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GC-MS Tune Failure Diagnosis: A Case Study

A laboratory sample vial resting on a sheet of chemical structures and formulas, representing analytical chemistry and mass spectrometry research.
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Expert Q&A: Choosing the Correct Ionisation Technique for Successful Mass Spectrometry Experiments