INSIGHTS ON QUALITY CONTROL
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Delivering Value Across Sites With Unified Quality Operations
Standardizing quality processes across 14 sites has enabled faster lead times. Discover how a unified platform reduces complexity, improves compliance, and delivers greater value for customers.
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Lessons From FDA 483s And Warning Letters: Cleanroom Compliance
Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.
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Why Cloud Migration Is The Key To Business Agility
Discover how transitioning to cloud-native architectures drives business agility in biopharma, reducing infrastructure costs, minimizing downtime, and accelerating time to market for novel therapies.
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Secondary Packaging: Inspection, Brite Stock Bottle Labeling, And Cartoning
Gain insight into a coordinated, around-the-clock approach that demonstrates how packaging efficiency can keep pace with urgent pharmaceutical launches and tight commercialization timelines.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance12/9/2024
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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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.
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Glucagon-Like Peptide-1 (GLP-1) Analogues Applications Notebook12/11/2025
View this collection of application notes about the chromatographic analysis and purification of GLP-1 analogues, including Semaglutide, Tirzepatide, Liraglutide, and Exenatide.
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Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC1/21/2026
Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.
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Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation3/5/2026
Maintaining high-purity water is vital for pharmaceutical production. Explore key strategies for system design, risk mitigation, and rigorous process control to ensure consistent regulatory compliance.
QUALITY CONTROL SOLUTIONS
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Tyvek® gives the premium microbial barrier protection for sterilized medical instruments and pharmaceuticals. Apart from protecting the medical devices and pharmaceutical products from physical damages, medical and pharmaceutical packages also should provide an effective microbial barrier and help to maintain the sterility of the products. Bacteria and viruses with sizes varying from 0.002 to 100 microns are a constant threat to pharmaceuticals and medical devices which in turn can be hazardous to the patients.
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The Milliflex® Rapid System 2.0 brings together membrane filtration and ATP bioluminescence to detect, image and quantify microcolonies of bacteria, molds and yeasts up to 4 times faster than compendial bioburden or sterility testing methods.
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Powerful tools for characterizing protein-protein interactions, structural stability, and formulation compatibility.
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Our solid forms plant exports 75% of its output, supplying products to 45 markets in 25 different languages.
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Integrated lab services deliver method development, validation, and testing across modalities, supporting quality, compliance, and formulation progress from early development to commercialization.