INSIGHTS ON QUALITY ASSURANCE
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Why Emerging Drug Developers Can't Afford To Delay Analytical Development
Rushing early pharma development by neglecting quality and analytical frameworks risks regulatory failures, clinical holds, and expensive rework.
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Quality Time With Oliver: Guest Michael Dominguez
Build a stronger CCIT strategy with practical guidance on risk assessment, method development, and validation, as well as how to improve collaboration between sponsors and testing laboratories.
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The Shift To GMP-Compliant Automation In CGT Manufacturing
Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.
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ADC Development Grows More Complex — SPR Insights Bring Clarity
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
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How AI-Enabled Validation Technologies Enable The Predictive Plant3/18/2026
Discover how AI-enabled digital validation shifts manufacturers from reactive compliance to predictive intelligence, connecting validation, asset, and quality data to accelerate digital maturity.
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Ensuring Performance And Compliance: Successful FAT Of Filling Line Isolator For Creative Lifesciences, Taiwan3/19/2026
Rigorous Factory Acceptance Testing ensures filling line isolators meet performance and safety standards. This validation is vital for aseptic integrity and protecting both product and operator.
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GMP Calibration Management8/8/2025
Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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Your Guide To Precise And Robust Separation Methods11/12/2025
Discover a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis.
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A Scalable Analytical Method For Quality-Driven AAV Characterization7/1/2026
AEX-HPLC has emerged as a robust, GMP-compatible analytical method for accurately characterizing AAV capsid composition, enabling consistent assessment of empty, partial, and full capsids to support product quality, process development, and regulatory readiness.
QUALITY ASSURANCE SOLUTIONS
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Analyzing GLP-1 receptor agonist (RA) drugs has become increasingly complex. Peptide structures, closely-related impurities, and rising demands for sensitivity, speed, and compliance are putting pressure on laboratories.
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Ensure operator safety and product purity with unidirectional airflow solutions. Explore how modular ISO 5 environments provide containment and cross-contamination control for critical processes.
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Gene therapies hold immense potential to provide long-lasting treatments for a wide range of diseases. At Cytiva, we offer GMP-compliant, end-to-end manufacturing solutions designed to support the development and commercialization of advanced medicines across multiple modalities – including AAV, adenovirus (AV), lentivirus (LV), plasmid DNA (pDNA) and exosomes. Our dependable suite of technologies and expertise ensures scalability, quality, and regulatory confidence at every stage of your journey.
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Whether you're looking to boost performance, enhance your capabilities, or simply get consistent, high-quality results, HyClone™ peak expression medium and HyClone™ prime expression medium are the solutions for you.