INSIGHTS ON QUALITY CONTROL
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Breaking Barriers In Malaria Prevention With A Mobile Cleanroom
The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.
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Mobile Lab For A Large Pharma Client
Completed in 2021, learn how this custom BSL-3 mobile laboratory received PHAC approval and ensured a secure environment for PPD powder-related MTech development work.
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Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2
Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.
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Mobile Gowning Cleanroom, Built To Meet ISO 7 Requirements
Uncover how Germfree designed and installed a mobile cGMP cleanroom on a 53′ tractor-trailer chassis to provide a flexible and efficient cleanroom solution tailored to the company’s needs.
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Improved GLP-1 Receptor Agonist Peptide Recovery6/30/2025
Discover how an innovative technology enhances LC-MS analysis of GLP-1 receptor agonists by minimizing peptide loss and improving assay sensitivity and consistency.
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Improving Bioprocess Monitoring And Control With Multivariate Data Analysis12/9/2024
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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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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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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Leachables Method Development, Validation And Relevant ICH References5/16/2025
It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.
QUALITY CONTROL SOLUTIONS
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Flow Sciences, Inc. (FSI) evaluates and ensures that every enclosure shipped to their customer meets all relevant standards. FSI performs procedures from the American Society of Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE) 110-2016 – Methods of Testing Performance of Laboratory Fume Hoods.
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API Hybrid Isolator designed to provide personnel protection while working with powder substances. Enclosure features include acrylic superstructure, black phenolic base, acrylic viewing panels, hinged door style, BIBO filtration with dual HEPA, top mount fan, vent kit, thimble connection, right and left side pass throughs, Go/No Go Red and Green Signal Light, removable draft shield with 6x 8” oval glove ports, 2x minihelic gauges, LED lighting, iris ports on both sides. LED lighting and Acrylic viewing panels maximize lighting across the workspace.
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Waters is providing a pathway for easier access to our latest innovative technologies with our FlexUP Technology Renewal Program.
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Developed for plasma protein binding determination and free fraction analyses, the Supel™ BioSPME 96-Pin Devices greatly improve upon the speed and simplicity of current sample preparation techniques.
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Sterility testing is a requirement to confirm that pharmaceutical products purporting to be sterile do not contain viable microorganisms before being released and administered to patients. So, it is vital that the method used for testing medical devices, pharmaceutical products, formulations, tissue materials, and other products is both reliable and accurate.