INSIGHTS ON QUALITY CONTROL
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Understanding FDA Calibration Requirements And Best Practices For Reducing Risks
Become equipped with the tools and strategies needed to strengthen your calibration efforts and better position your organization for success in regulatory audits.
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Delving Into Gene Expression Data Analysis And Experimental Reproducibility
Scientific reproducibility is essential for credible research. Learn to navigate standardized frameworks, refine normalization techniques, and ensure your data remains transparent and verifiable.
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Lentiviral Vector Upstream Process
Scalable lentiviral vector production is moving beyond adherent systems. Learn how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.
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High-Throughput Pyrogen Testing In A Multimode Microplate Reader
Explore a faster, high‑sensitivity approach to pyrogen detection that uses an NF‑κB reporter system to measure both endotoxin and non‑endotoxin contaminants to enable shorter workflows.
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ICH Q9 Revision 1: Enhancing Quality Risk Management8/12/2024
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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Leachables Method Development, Validation And Relevant ICH References5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
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Aseptic Filling Quality Through Precision3/20/2026
Precise measurement shapes every reliable workcell. Meet Andrew, a specialist who verifies components with micron‑level accuracy, ensuring each piece is built to perform exactly as designed.
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Practical Solutions For Protein Analytics And Residual DNA Testing11/12/2025
Discover practical solutions for common quality control bottlenecks in biotherapy manufacturing. Learn how to improve protein analytics and DNA testing robustness and accelerate time to market.
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Don't Let Seals Break Your Batch: A Risk-Based Approach To Column Maintenance7/28/2025
Optimize biopharmaceutical manufacturing by implementing risk-based seal maintenance. Tailor replacement protocols using data and advanced monitoring for enhanced efficiency and compliance.
QUALITY CONTROL SOLUTIONS
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Airborne ultrasound is a referenced technology in the new USP <1207> Chapter Guidance as a deterministic test method for seal quality testing, is an ASTM Test Method F3004 and FDA Recognized Standard for seal quality integrity testing.
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Partner with a trusted, globally proven CDMO whose world-class, rapidly scalable facilities and unwavering commitment to quality help accelerate patient access to life-saving biologics.
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Maintain a Grade-A environment for sterile fill-finish with a dual-pressure aseptic isolator. Accelerate campaign turnarounds using integrated vaporized hydrogen peroxide.
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Explore the latest in contaminant detection technology with this pharmaceutical metal detector for tablets and capsules. Ensure the highest quality products with its failsafe rejection system and more.
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Traditional bioburden testing (or microbial limit testing) takes several days to grow visible colonies of microorganisms, so identifying these and initiating corrective action takes longer. The Milliflex® Quantum system quantitatively detects microbial contamination in filterable samples in as little as a third of the time it takes with traditional plate-based monitoring methods. The Milliflex® Quantum system is based on fluorescent staining of all viable microorganisms, making emerging microcolonies visible to the system when they’re still too small to be seen with the naked eye. After rapid detection, the colonies can be reincubated to grow into visible colonies and be identified by any method—an approach that cleverly combines rapid and compendial bioburden testing.