INSIGHTS ON QUALITY CONTROL
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Activate Advanced Contamination Control Technology To Safeguard Your Cell Therapy
The most common contamination risks in cell therapy manufacturing are open processes that leverage different products, inflexible instruments, labor intensive workflows, lack of in-line monitoring, and zero failure tolerance.
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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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Aseptic Expertise And Delivery Of Services
A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.
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Ready To Bring GxP Training To The Next Level? LearnGxP
Upgrade your compliance strategy with accredited, scenario-based GxP training. Eliminate risks like failed inspections and costly deviations with a modern, global solution.
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Your Digital QC Companion For Sterility Testing8/13/2024
Discover software designed to ensure fully accurate data recording in sterility testing and that complies with 21 CFR Part 11 standards for electronic records and signatures.
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Development Of Separation Methods For GLP-1 Synthetic Peptides6/30/2025
Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.
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Engineering Excellence: JHS And Groninger's Partnership Drives Pharma Innovation And Local Growth7/7/2025
JHS and groninger’s partnership powers expansion with advanced aseptic filling lines, driving innovation, quality, and community growth through shared values and strategic collaboration.
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Monitoring, Media Fills, And QC: Demonstrating Sterility Assurance At Your CDMO2/13/2026
CDMO guide on environmental monitoring, media fills, and QC to prove sterility assurance in aseptic manufacturing—key elements of the Contamination Control Strategy beyond facility design.
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Building Control Strategies: It's Time To Go Digital1/24/2025
Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.
QUALITY CONTROL SOLUTIONS
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Blue Mountain RAM® delivers built-in Asset Performance Management (APM) capabilities that help GMP-regulated organizations monitor equipment health, detect risk trends, and optimize performance — without sacrificing compliance.
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Verify barrier integrity in aseptic environments using standardized pressure loss testing. Ensure repeatable workflows and regulatory compliance with portable, wireless detection technology.
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Choose the ideal mix of services with our FlexUP Technology Renewal Program for continuous operation in your laboratory and across your enterprise.
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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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A variety of test methods exist to challenge package quality and performance. The objective of a feasibility study is to evaluate if a recommended CCI solution works and establish the optimal test parameters and Limit of Detection (LoD).