INSIGHTS ON QUALITY CONTROL
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ICH Q9 Revision 1: Enhancing Quality Risk Management
ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Method Migration Of A Normal Phase HPLC Method For Tocopherols
The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.
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Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity
Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.
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Delivering Value Across Sites With Unified Quality Operations1/21/2026
Standardizing quality processes across 14 sites has enabled faster lead times. Discover how a unified platform reduces complexity, improves compliance, and delivers greater value for customers.
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Practical Considerations For Aseptic Gowning In Contamination Control Strategies2/26/2026
Master the complexities of aseptic gowning and Annex 1 compliance. Explore risk-based strategies to mitigate human-source contamination and strengthen your facility's sterility assurance.
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Designing An Environmental Monitoring Solution For GMP Applications3/5/2026
Implement robust contamination control strategies that align with current regulatory requirements. Optimize your environmental monitoring framework through precise design and data-driven analysis.
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Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality8/29/2024
Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.
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The Hidden Costs Of Paper Logbooks3/19/2026
Stop losing time and capacity to manual paperwork. Learn how digital workflows eliminate compliance risks and unlock the actionable data needed to optimize life sciences manufacturing.
QUALITY CONTROL SOLUTIONS
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Advance your cell processing capabilities with high-containment isolation. Ensure cGMP compliance and superior sterile protection for your most sensitive and critical biological workflows.
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Secure your laboratory environment when handling infectious materials. High-containment systems provide leak-tight protection for BSL 2+ through 4 applications, ensuring operator safety.
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Elevate your sterile compounding with advanced isolation technology. Ensure rigorous safety, superior containment, and improved workflow efficiency for critical pharmacy and laboratory operations.
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Three media, Friis, Frey, and Hayflick, are used to detect different ranges of mycoplasmas. MilliporeSigma offers all three as ready-to-use, with longer shelf-life broth and plates for compendial testing.
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The Milliflex® Rapid System 2.0 brings together membrane filtration and ATP bioluminescence to detect, image and quantify microcolonies of bacteria, molds and yeasts up to 4 times faster than compendial bioburden or sterility testing methods.