INSIGHTS ON QUALITY CONTROL
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Your Guide To Precise And Robust Separation Methods
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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The Scalability Of Depth Filters For CHO Cell Culture Clarification
Clarification using depth filtration is standard in monoclonal antibody (mAb) manufacturing. Here, we showcase the scalability of Stax™ mAx depth filters, demonstrating their effectiveness.
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Tackling Residual DNA Testing In Biotherapy Manufacturing
Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.
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Host Cell Impurities, Bioassays, Micro-Flow Imaging
Ensuring the safety and efficacy of cutting-edge biopharmaceuticals hinges on meticulous quality control measures. Explore the role of qPCR and MFI in safeguarding drugs from potential contamination.
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Understanding cGMPs For Phase 1 Investigational Drugs8/15/2025
Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.
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Digitalizing Pharma Control Strategies: A Roadmap1/24/2025
Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.
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Method Migration Of A Normal Phase HPLC Method For Tocopherols9/17/2024
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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Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance2/24/2026
Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.
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How To Achieve Right-First-Time Manufacturing1/21/2026
Modernizing QC requires more than isolated fixes. Discover how cloud-based platforms unify systems, automate workflows, and improve data access to help labs reduce cycle times and minimize rework.
QUALITY CONTROL SOLUTIONS
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Realize the full potential of your cell therapy research. Experience end-to-end support to overcome developmental complexities, helping you to efficiently and safely commercialize your groundbreaking treatments.
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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.
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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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The most powerful and versatile rheometer for your laboratory.
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Ensure sterile integrity with advanced barrier systems. These controls offer real-time monitoring and flexible pressure settings to protect both your products and staff effectively.