INSIGHTS ON QUALITY CONTROL
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Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance
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 LIMS Supports QC Scaling At Forge Biologics
Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.
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Organ-Chips Outperform Animal Models And Spheroids
Examine how 780 human Liver-Chips were assessed for their ability to predict drug-induced liver injury from small molecules.
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Contamination Control Strategies For Innovation And Regulatory Compliance
Creating a robust contamination control strategy is essential for pharmaceutical manufacturing. Learn to align risk management and technical controls to ensure lasting regulatory compliance.
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A New Framework For Identifying Nitrosamine Risks And Derisking Products6/18/2024
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
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How Do You Navigate GxP Compliance?4/21/2026
Heightened FDA scrutiny demands a shift from fragmented data to unified digital systems. Learn how to automate QA tasks, secure data integrity, and maintain a constant state of inspection readiness.
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Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity6/19/2024
Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.
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Strategic CMC Planning Through A Phase-Appropriate Quality Approach5/28/2024
A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.
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Leveraging A Modern HPLC System For Peptide Drug Substances Analysis8/22/2024
This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.
QUALITY CONTROL SOLUTIONS
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As the only major supplier worldwide, we offer all three media to test for Mycoplasma according to EP 2.6.7 and USP 63 as both broth and agar plates. These ready-to-use Friis, Frey, and Hayflick culture media help to make the cumbersome compendial procedures of testing cell cultures, raw materials, intermediates, and final products for mycoplasmas easier.
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Explore the design services offered by the Gibco Media by Design team including cell line development, media and feed panel evaluations, bioproduction analytics and more.
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The Esco IntelliGlove Tester (EIGT) is an advanced glove integrity testing solution designed for pharmaceutical, biocontainment, and aseptic manufacturing environments where consistency, traceability, and regulatory compliance are essential.
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Using the correct media is critical to ensure microbiological quality. Explore a portfolio of culture media and substances for sample preparation, microbial enumeration tests, and tests for specified microorganisms.
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The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.