INSIGHTS ON QUALITY ASSURANCE
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Why Composable Manufacturing Execution Is Becoming The New Standard
Low-code MES promises speed, but agility comes from ownership. Composable, no-code approaches give operations teams the ability to change workflows themselves and respond faster to disruption.
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The Impact Of The FDA's New CSA Draft Guideline
Ensure product quality and patient safety by examining the FDA's draft guideline on Computer Software Assurance that emphasizes a risk-based approach to streamline software validation.
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Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process
Upgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.
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Global Regulatory Harmonization: Comparisons In Aseptic Barrier Systems
Compare global aseptic standards from the FDA, EMA, PIC/S, and WHO. Gain insights into how advanced barrier systems harmonize international requirements to ensure sterile product integrity and safety.
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Comparison Of Constant- And PulsedField Electrophoresis3/4/2026
Accurate sizing of large DNA fragments is crucial in long‑read sequencing. Examine how different electrophoresis methods perform with 10–20 kb smears and how to choose the most reliable approach.
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Discover How Our Polyurethanes Can Enhance Your Medical Device Designs10/31/2025
Medureon™ is a family of medical-grade polyurethanes engineered for high performance, biocompatibility, and reliability in advanced, critical medical device applications.
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Good AI Practice In GxP: 4 Implications Of FDA/EMA's Joint AI Principles7/17/2026
See how quality, validation, and IT teams can prepare for the next generation of AI governance in regulated manufacturing.
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Aggregation In Antibody-Drug Conjugates: Causes And Mitigation9/1/2025
Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
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Quantifying Endotoxins Via Absorbance Or Fluorescence3/20/2026
Find out how endotoxin assays use Factor C activation to generate measurable absorbance or fluorescence signals, with guidance on selecting detection formats and implementing scalable workflows.
QUALITY ASSURANCE SOLUTIONS
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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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Protect your controlled environment by neutralizing particulate threats at the entry point. High-velocity filtration ensures stringent air quality standards remain consistent and validated.
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Our solutions have been specified in the testing process for the top two GLP-1 manufacturers
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Protect sterile materials during transfer with mobile ISO Class 5 airflow zones. These customizable trolleys eliminate contamination risks while ensuring operator safety and process integrity.
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Achieve ISO Class 5 containment for large-scale research equipment and robotics. These advanced enclosures ensure multi-level protection while maintaining rigorous aseptic standards.