INSIGHTS ON QUALITY ASSURANCE
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Stories From The Field: Supporting Critical Steps In Fill And Finish
Explore the critical final step in drug development—formulation and filling—and discover expert strategies that can help streamline operations, reduce risk, and enhance efficiency.
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Molecular Approaches To Streamline Cell Therapy Product Analytical Testing
Learn how rapid molecular methods of cell therapy testing like qPCR for mycoplasma, sterility, and lentiviral quantification are key to accelerating product release and timely treatment delivery.
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Build An AAV8 Platform: Lessons From A Collaborative Development Journey
Explore how a modular AAV8 platform enables scalable, GMP-ready gene therapy manufacturing with reproducible outcomes, streamlined tech transfer, and adaptability across serotypes.
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Compressed Gas Risk Assessment: A Significant Step In Your CCS
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.
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Automation-Assisted Washing Of Multicellular 3D Spheroids11/7/2025
Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.
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Best Practices In Commissioning And Qualification7/5/2024
An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.
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Can Today's ELNs Support Tomorrow's Labs?3/14/2024
The global electronic laboratory notebook (ELN) market is growing, however, ELNs must form part of a more comprehensive data strategy and ecosystem or they can impede progress.
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The Role Of IV Bag Inspection In Drug Manufacturing2/5/2025
Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Learn more about automated leak detection and quality control innovations to optimize your business.
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A Simple Method For Cell Growth Media Preparation11/3/2025
Explore how powder media and sterile fluid handling can reduce contamination risk and improve efficiency in viral vector production, especially for HEK293-based AAV workflows.
QUALITY ASSURANCE SOLUTIONS
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Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.
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The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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Proactively manage risks of pharmaceuticals, medical devices and other products with TrackWise Digital. The built-in templates comply with ISO 14971 and ICH Q9 allowing manufacturers to manage risks throughout the entire product lifecycle directly within TrackWise Digital.
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Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.
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The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).